Explore the medical device requirements currently available for China, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Medical device advertising must be reviewed before publication by the advertising review authority designated by the province, and an advertisement approval number obtained;未经审查，不得发布. Content must be true and lawful, based on the registered/filed device IFU, without false, exaggerated or misleading claims.
What expires, what is retained periodically, and when must renewal start?
The medical device registration certificate is valid for 5 years. Class I filing has no ordinary 5-year certificate.
Renewal (延续注册) must be applied for with the original registering authority at least 6 months before the certificate expires.
If the authority fails to decide on a timely renewal application within the statutory time limit, the renewal is deemed approved.
Excerpt in English as published in the official NMPA translation.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Substantive changes to a registered Class II/III device (design, raw materials, production process, intended scope of use, method of use, etc.) that may affect safety or effectiveness require change registration (变更注册) applied for with the original registering authority.
Changes to a registered device other than those requiring change registration must be filed (备案) with the original registration authority within 30 days from the date of the change.
Excerpt in English as published in the official NMPA translation.
Which clinical or IVD performance evidence or study is required and accepted?
Registration/filing requires clinical evaluation unless a Decree Art. 24 exemption applies; evaluation may be satisfied either by a clinical trial or by analysis of clinical literature and data of equivalent (same-variety) devices. Clinical trials must follow medical device GCP at qualified trial institutions, with filing to the provincial drug regulatory department.
Clinical trials of Class III devices presenting high risk to the human body require prior NMPA approval before the trial may proceed; the approval application is decided within 60 days with silence deemed consent.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device is any instrument, apparatus, implement, in-vitro diagnostic reagent or calibrator, material or other similar or related item used directly or indirectly on the human body, including required computer software, whose action is obtained mainly by physical means and not by pharmacology, immunology or metabolism (which may play only an auxiliary role). IVD reagents, calibrators and software fall inside the device definition.
Which evidence, local deltas, formats, and signatures are required?
NMPA Announcement No. 121 of 2021 prescribes the mandatory registration dossier requirements and the certificate/decision document formats, with separate annexes for first registration, change, renewal and clinical-trial approval submissions; effective 2022-01-01, repealing the 2014 No. 43 formats.
Effective from 2022-01-01
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The China agent designated by an overseas holder must carry out adverse-event monitoring for the imported devices sold in China and cooperate with the overseas holder in re-evaluation obligations; holder and agent must maintain an information-transfer mechanism.
Effective from 2019-01-01
An overseas registrant exporting Class II/III devices to China must designate a Chinese legal-person enterprise (我国境内企业法人, the China agent) that submits the registration application to NMPA on its behalf; the foreign manufacturer remains the registrant/holder.
Which establishment licences, importer permissions, and distribution controls apply?
Distribution controls are tiered: operating Class II devices requires filing (备案) with the municipal drug regulatory department; operating Class III devices requires an operation license (经营许可) from the same municipal department.
Manufacturing Class II or III devices requires a production license (生产许可) applied for from the provincial drug regulatory department, supported by evidence of GMP compliance and the device registration certificate.
What regulator fee applies to this class, route, event, and date?
Registration fees are waived for innovative medical device registration applications filed by small and micro enterprises (小微企业), per the NMPA administrative licensing fee schedule.
Which label and IFU elements, languages, symbols, and translation controls apply?
Imported devices must have a Chinese IFU and Chinese label; the IFU must state the country of origin and the name, address and contact details of the China legal-person enterprise designated by the overseas registrant/holder. Devices without compliant Chinese labels may not be imported.
Labels and IFUs must use Chinese, conforming to national language norms; other languages may be added, but the Chinese text prevails.
Effective from 2014-10-01
Order No. 6 of 2014, in force since 2014-10-01; every minimum sales unit must carry an IFU (Art. 7).
Which current law, regulation, guidance, and transition provisions apply?
Primary legislation: Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), State Council Decree No. 739, in force since 2021-06-01.
Effective from 2021-06-01
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Registrants/holders must: establish and maintain a functioning QMS suited to the product; formulate and effectively implement post-market research and risk-control plans; conduct adverse-event monitoring and re-evaluation as required by law; and establish and operate product traceability and recall systems.
Holders must complete a periodic risk evaluation report (定期风险评价报告) for the previous year within 60 days after each anniversary of first approval/filing; NMPA-registered products report to the national monitoring centre and provincially registered products to the provincial centre; Class I reports are retained by the holder.
Effective from 2019-01-01
Which current form, portal, account, and submission package must be used?
Device licensing items are standardized and published on the NMPA government service portal (zwfw.nmpa.gov.cn) as 办事指南 items covering forms, materials, fees and statutory clocks; e.g. import Class III first registration is administered by NMPA as a national-level administrative licensing item.
Which QMS, audit, inspection, and certificate scope is accepted or required?
The revised Medical Device GMP (医疗器械生产质量管理规范) takes effect 2026-11-01 and simultaneously repeals the 2014 GMP (CFDA Announcement No. 64 of 2014, in force since 2015-03-01). Until 2026-11-01 the 2014 GMP remains the manufacturing QMS standard.
Effective from 2026-11-01
During registration review, the drug regulatory department organizes a quality-management-system verification (registration QMS check) when it considers one necessary.
Which recall, FSCA, notice, and authority-coordination duties apply?
Where a registered/filed device fails mandatory standards or the registered product technical requirements, or has other defects, the registrant/holder must immediately stop production, notify operators, user units and consumers to stop operation and use, recall marketed units, take remedial or destruction measures, record and publish information, and report the recall and handling to the drug regulatory and health authorities.
Recalls are classified by hazard severity (Art. 13: Level 1 = possible/actual serious health harm; Level 2 = temporary or reversible harm; Level 3 = lower likelihood of harm but recall warranted). After deciding a recall, the manufacturer must notify operators/user units or users within 1 day (Level 1), 3 days (Level 2) or 7 days (Level 3). Level 1 recall notices are published on the NMPA website and central major media; Level 2/3 on provincial department websites (Art. 14). For recalls, the responsible manufacturer includes the China agent designated by the overseas manufacturer (Art. 3).
Effective from 2017-05-01
Which registration, notification, listing, reliance, or conformity route applies?
Domestic Class II registration is reviewed and approved by provincial drug regulatory departments; domestic Class III and all imported devices (Class I filing and Class II/III registration) are handled by NMPA, with CMDE (NMPA center for medical device evaluation) conducting technical review of NMPA-level applications.
Class I devices are subject to product filing (备案); Class II and Class III devices are subject to product registration (注册) with acceptance, technical review and administrative decision.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Regulatory reference
Albanian device registration with AKBPM rests on CE conformity: Law 21/2020 amending Law 89/2014 provides that conformity with the essential requirements is confirmed by a CE marking document or, equally, an FDA certification document (held fact), and the AKBPM registration dossier under Order 360/2016 as amended by Order 734/2018 requires a copy of the declaration of conformity and/or CE certificate issued under technical rules VKM 731/2015, 508/2015 and 189/2016. No provision refers to China, NMPA or certificates from the country of manufacture, so an NMPA registration has no documentary or procedural role.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
albania
NMPA Class II/III certificates and Class I filings; target all Albanian classes
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2018-10-18
Source passage: Pas tërheqjes së Autorizimit, aplikanti plotëson dosjen për aplikim bazuar në Urdhrin nr. 360 date 22.08.2016 ndryshuar në Urdhrin nr. 734 date 18/10/2018, me dokumentacionin si vijon: [...] Fotokopje e deklaratës së konformitetit dhe/ose CE (bazuar në VKM nr. 731; 508; 189)
Prior approval / evidence record
Algeria's device regime (Décret exécutif n° 20-324 of 22 November 2020 and its implementing arrêté of 10 May 2021) requires an imported device to be documented by the competent authority of the country of origin: a certificate of free sale or equivalent and the origin-country marketing authorisation in the homologation dossier, and ongoing reporting of any prohibition or restriction imposed by the origin-country health authority, while the homologation decision itself rests on ANPP's own commission evaluation. For a China-manufactured device the NMPA registration certificate (or Class I filing) is the origin-country authorisation this evidence rests on, but neither text names NMPA or any foreign authority whose approval abridges the Algerian review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
algeria
All device classes (I-III) subject to ANPP homologation
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2020-11-22
Source passage: Art. 19. — La demande d'homologation déposée auprès de l'agence nationale des produits pharmaceutiques doit être accompagnée d'un dossier technico-administratif comprenant les renseignements d'ordre : — administratif sur le dispositif médical et le demandeur ; — technique, de la conception du dispositif médical jusqu'au produit fini ; — scientifique et données cliniques, le cas échéant. [...] Art. 36. — durant la période de validité de la décision d'homologation, il est fait obligation au détenteur et/ou à l'exploitant de la décision d'homologation de déclarer immédiatement à l'agence nationale des produits pharmaceutiques : [...] — toute interdiction ou restriction imposées par l'autorité de santé compétente du pays d'origine ou de tout autre pays où le dispositif médical est commercialisé et toute autre information nouvelle qui pourrait influencer l'évaluation du rapport de sécurité du dispositif médical concerné.
Regulatory reference
Decreto 892/2025 (in force 60 days after 17 Dec 2025) and ANMAT Disposición 236/2026 create a notification-based import route for Class I and II medical devices that are authorized for public consumption in at least one country of Anexo I of the decree, and exempt such products from local testing on presentation of a free-sale certificate. Anexo I lists Australia, the EFTA countries, the EU countries, the United States, Israel, Japan and the United Kingdom; China is not included, so an NMPA certificate does not open this route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
argentina
NMPA Class I filings and Class II certificates for devices that are ANMAT Class I/II (and IVD A/B without cold chain)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-02-15
Source passage: ARTÍCULO 2º.- ... productos médicos de clase de riesgo I y II ... siempre y cuando: 1. se encuentren autorizados para su consumo público en el mercado interno de al menos uno de los países o grupo de países que se indican en el ANEXO I (IF-2025-115076139- APN-MDYTE) del presente decreto
Prior approval / evidence record
For imported Class II–IV devices, Disposición ANMAT 727/2013 Art. 3 g3) requires an authenticated copy of the registration proof issued by the competent authority of the country where the device is manufactured, issued within the previous 24 months and legalized/apostilled; for China-made devices the NMPA registration certificate is therefore a mandatory dossier document but confers no abridged review. Separately, Art. 5 allows ANMAT, at its discretion, to treat a device authorized by a foreign health authority whose regulatory functions and legislation are 'in line with' Argentina's framework as meeting similar quality/safety/efficacy characteristics and to exempt it from certain dossier items; the disposición deliberately abolished the former country list (Anexo III of Disposición 5267/06), so no official list includes or excludes China.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
argentina
NMPA Class II/III certificates (and Class I filing proof) for ANMAT Class II, III and IV devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2013-02-08
Source passage: g3) Copia autenticada del comprobante de registro otorgado por la autoridad competente, en el país donde el producto médico es fabricado con fecha de emisión no mayor a 24 meses anteriores a la presentación del expediente. ... Art. 5 — Al momento de la inscripción de un producto médico en el RPPTM autorizado por una Autoridad Sanitaria de otro país, cuyas funciones regulatorias, fiscalizadoras y legislación resulten acordes a nuestro marco regulatorio vigente ... esta Administración Nacional podrá considerar que dicho producto cumple con similares características en términos de calidad, seguridad y eficacia.
Prior approval / evidence record
A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.
Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references
Origin Country Evidence
Evidence Only
Import Control
Yes
Yes
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
Prior approval / evidence record
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Regulatory reference
TGA accepts market-authorisation evidence only from its designated comparable overseas regulators and assessment bodies: EU notified bodies (MDD/AIMDD/IVDD, MDR, IVDR), US FDA (PMA and 510(k)), Health Canada, Japan MHLW/PMDA, Singapore HSA, and UK approved bodies designated by MHRA, with MDSAP certificates as manufacturer evidence. China's NMPA is not a comparable overseas regulator, so an NMPA registration certificate cannot be used as manufacturer evidence or product-assessment evidence for ARTG inclusion or to abridge a TGA conformity assessment.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
australia
All classes; ARTG inclusion applications and abridgement of TGA conformity assessment
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2018-10-01
Source passage: Premarket approval and 510K decisions of the United States Food and Drug Administration (FDA) • Approvals and medical device licences issued by Health Canada • Pre-market approvals or certification from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) • Registrations or approvals of the Singapore Health Sciences Authority (HSA)
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
austria
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
For Class B devices the dossier requires the free sale certificate from the country of origin, and for Class C/D the country-of-origin FSC is required alongside a reference-country FSC. A China NMPA registration certificate or NMPA-based FSC satisfies the country-of-origin requirement for China-made devices; no abridged review follows.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bangladesh
Bangladesh Class B (NMPA Class I/II equivalents); also the origin-FSC component for Class C/D
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2015-01-01
Source passage: 1. Regulatory status in the country of manufacture and in other developed economies : (a) For class B Devices, FSC from country of origin,
Regulatory reference
For Class C and D devices the DGDA registration dossier must contain a free sale certificate from any one of the EU, USA, Canada, Australia and Japan in addition to the country-of-origin FSC. China/NMPA is not among the accepted reference countries, so a China-made Class C/D device cannot rely on its NMPA certificate alone.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bangladesh
Bangladesh Class C and D (NMPA Class II/III equivalents)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2015-01-01
Source passage: (b) For class C and D Medical Devices , FSC from any one of the countries - EU, USA, Canada,Australia and Japan and FSC from country of origin. (c) Conformityassessment certificate or equivalent certificate has to be submitted.
Prior approval / evidence record
Since 7 July 2024, Ministry of Health Resolution No. 51 of 19 May 2021, as described in the Belarusian Embassy procurement notice, allows unregistered medical devices produced by residents of the People's Republic of China and in circulation in China to be offered in Belarusian public-procurement procedures. The bidder must include copies of the Chinese export certificate and the Chinese device registration certificate, a valid contract with the Centre for Expertise and Testing in Health Care for pre-registration technical work, and an undertaking to hold a Belarusian registration certificate by the delivery date.
china
nmpa
Chinese medical-device registration certificate and export certificate for the eligible China-produced device
belarus
China-produced, China-registered devices covered by the procurement notice; equivalence of a Class I filing to the required registration certificate is not established
Procurement Admission
facilitated
Public Procurement
Yes
Yes
Effective from 2024-07-07
Source passage: С 07.07.2024 в процедурах государственных закупок в Республике Беларусь разрешено предлагать незарегистрированные медицинские изделия, произведенные в Китайской Народной Республике и находящиеся в обращении на территории Китайской Народной Республики. Несмотря на вышеуказанное, к моменту поставки медицинское изделие должно быть зарегистрировано участником государственной закупки в соответствующем порядке. ... копии сертификата на экспорт медицинской продукции и сертификата о регистрации медицинского изделия;
Prior approval / evidence record
For foreign-made devices the national dossier must include a document on registration and/or authorisation to market the device in the country of manufacture (registration certificate, free-sale certificate, declaration of conformity or a dated screenshot of the regulator's official website), legalised and translated; an NMPA registration certificate is that document for China-made devices. Under the EAEU route the same evidence is an 'if available' item. Neither route abridges the Belarusian or EAEU expertise on the basis of NMPA approval.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
belarus
All classes under the national registration route (Minhealth Resolution 55, Appendix 1, item 2.3) and the EAEU route (Decision 46 dossier item 10)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2015-04-23
Source passage: (held fact) документ о регистрации и/или разрешении к применению медицинского изделия в стране производителя (регистрационное удостоверение, сертификат свободной продажи, декларация о соответствии, скриншот официального сайта регулятора с датой)
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
belgium
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Status is official-source-verified for the text of the draft; the conditions and the reliance-recognition value record that the instrument is not in force. This is the deliberate 'do not upgrade a policy aspiration into an operating route' fact for Botswana. The draft would also give registration a five-year term (draft reg. 20(1)).
Prior approval / evidence record
China NMPA medical device registration certificate
No
No route. The NMPA is not named among the ICH members, observers or mutual-recognition-associated authorities in G01 s.3.1.26, and G01's device guideline names no recognition procedure for it. An NMPA certificate may be filed where the Authority asks for proof of registration in other countries, but it carries no procedural benefit and does not abridge BoMRA's evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
China's National Medical Products Administration is named as an acceptable reference authority in the exemption pathway, but the recognition is expressly limited to Class A and Class B medical devices; the same limitation is applied to SAHPRA. China NMPA is not a Stringent Regulatory Authority under BoMRA's SRA definition and so cannot ground the Class C or Class D abridged criteria.
China National Medical Products Administration (NMPA) marketing authorisation - Class A and Class B medical devices only
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2023-04-01
Filed as its own fact because China NMPA is the reference approval the customer question asks about explicitly, and because the class limitation is the actionable part. OCR interleaving of the parenthetical is flagged in the accompanying exemption-route fact. NMPA's absence from the SRA definition is verified separately at s. 3.1.26 of BOMRA/ER/MED/P04/G01.
Prior approval / evidence record
For devices that are not on the interim register/listing, BoMRA's exemption guideline makes a foreign marketing authorisation a required piece of evidence: a copy or proof of the marketing authorisation issued by a relevant Reference Regulatory Authority, Singapore HSA, China NMPA (Class A and B only) or SAHPRA (Class A and B only), and/or a CE certificate issued by a European notified body under MDD 93/42/EEC, IVDD 98/79/EC, MDR (EU) 2017/745 or IVDR (EU) 2017/746, and/or proof of a WHO EUL or Prequalification acceptance letter. Approval places the device on an exempted list with a six-month validity.
Reference Regulatory Authorities recognised by BoMRA; Singapore Health Sciences Authority; China NMPA (Class A and B only); South African Health Products Regulatory Authority (Class A and B only); CE certificate from a European notified body under MDD/IVDD/MDR/IVDR; WHO EUL or WHO Prequalification acceptance letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2023-04-01
Excerpt read from the OCR pass over BoMRA's scanned copy (download/98/exemptions/25635/...). In s. 5.5.1 the parenthetical '(Only for Class A & B medical devices)' is interleaved by the PDF's line order and applies to China NMPA and to SAHPRA; the wording has not been altered but the reading is flagged. BoMRA's own revision sheet records the addition of 'China National Medical Products Administration (Only for Class A & B medical devices)' at Issue 3.0 and 'by European notified bodies (Except Class A)' at Issue 2.0.
Regulatory reference
ANVISA's optimized (reliance) review for Class III/IV device registration under RDC 741/2022 is available only for devices previously authorized by an AREE listed exhaustively in IN 290/2024 Art. 6: TGA (ARTG), Health Canada (Medical Device Licence), US FDA (510(k)/PMA/De Novo) and Japan MHLW (Shonin). China's NMPA is not listed, so an NMPA registration certificate gives no access to the optimized procedure and the ordinary route (RDC 751/2022 / RDC 830/2023) applies.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
brazil
NMPA Class II/III certificates and Class I filings; target: ANVISA Class III/IV registration (optimized procedure)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-03
Source passage: Art. 6º Para fins de adoção do procedimento otimizado de análise são consideradas as seguintes AREE e respectivas comprovações de registro ou autorização: I - Austrália: Australia Therapeutic Goods Administration (TGA) - Australian Register of Therapeutic Goods (ARTG); II - Canadá: Health Canada (HC) - Medical Device Licence; III - Estados Unidos da América (EUA): US Food and Drug Administration (US FDA) - 510(k) Clearance, Premarket Approval (PMA) ou 513(f)(2) "De Novo"; e IV - Japão: Japan Ministry of Health, Labour and Welfare (MHLW) - Pre-market approval (Shonin).
Prior approval / evidence record
NMPA Commissioner Jiao Hong and ANVISA Director-President Antonio Barra Torres signed a Memorandum of Understanding on cooperation on 26 November 2020 covering information exchange in the regulation of drugs, medical devices and cosmetics. ANVISA's official cooperation page lists the 'Memorando de Entendimento entre Anvisa e NMPA' under China, and a separate BRICS regulators' MoU. Neither instrument creates recognition of NMPA registrations; they are information-exchange frameworks.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
brazil
All device classes (framework MoU; no product-level effect)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2020-11-26
Source passage: The National Medical Products Administration (NMPA) Commissioner Jiao Hong signed a memorandum of understanding (MoU) on cooperation with Antonio Barra Torres, head of the Brazilian health regulatory agency ... on Nov 26. ... have agreed to further strengthen information exchanges in regulation of drugs, medical devices and cosmetics under the framework of the MoU
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bulgaria
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
Health Canada issues a Class II-IV medical device licence only on its own review of the application prescribed by section 32 of the Medical Devices Regulations (SOR/98-282); the Regulations contain no reliance or abridged licence route based on a foreign marketing authorisation, so a China NMPA registration certificate does not shorten or replace the Canadian licence review. NMPA appears in Health Canada's List of Regulatory Agencies only for the sections 61.2/68.3 foreign risk notification duty.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
canada
NMPA Class II/III -> Canada Class II-IV licences
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: Section 32 prescribes the content of a Class II, III or IV licence application; no provision refers to foreign marketing authorisations. Canada.ca list entry: 'National Medical Products Administration' under 'China' (Date modified 2024-01-24).
Regulatory reference
Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72-hour foreign risk notification duty.
Page issued 2024-01-03, modified 2024-01-24.
Prior approval / evidence record
Decreto Supremo 825/1998 Art. 21 a) 6 requires, for every imported device subject to control, a certificate for export purposes issued in the country of origin, authorized by the corresponding state authority and duly legalized; an NMPA-issued export/free-sale certificate therefore satisfies this documentary requirement for China-made devices. Neither DS 825 nor Decreto Exento 25/2026 (which brought a further group of devices/IVDs under registration) names any foreign reference agency or provides an abridged review based on foreign approvals; conformity is verified by ISP against NCh-ISO 16142, 13485 and 14971 and product standards.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
chile
NMPA Class I/II/III (all ISP classes I–IV, since Class I requirements apply cumulatively to higher classes)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 1999-08-21
Source passage: 6. Certificado para propósitos de exportación otorgado en el país de origen, autorizado por la autoridad estatal correspondiente y debidamente legalizado, en el caso dispositivos médicos que se importen a Chile.
Prior approval / evidence record
For imported devices, Decreto 4725/2005 Art. 29 b) requires a certification from the competent authority of the country of origin stating that the product is authorized for production or marketing there; for China-made devices the NMPA registration certificate or filing record fulfils this requirement. The full INVIMA dossier (technical studies, sterilization, clinical evidence) still applies because China is not a reference country.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
colombia
NMPA Class I filings and Class II/III certificates for all INVIMA classes of imported devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2005-12-27
Source passage: b) Certificación de la autoridad competente del país de origen en el que conste que el producto ha sido autorizado para su producción o comercialización en el territorio del país de origen.
Regulatory reference
Decreto 4725/2005 Art. 29 b) names the 'países de referencia' exhaustively as the European Economic Community, the United States, Canada, Japan and Australia (plus countries with a mutual recognition agreement), and Decreto 3275/2009 (Art. 18 parágrafo 3) lets a free-sale certificate from those reference countries stand in for technical studies, sterilization and clinical data for class I, IIa and IIb devices. China is not a reference country and Colombia has no mutual-recognition agreement with it, so an NMPA certificate cannot replace technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
colombia
NMPA Class I/II/III; target INVIMA classes I, IIa, IIb (Decreto 3275/2009 homologation) and reference-country CLV substitution under Art. 29 b)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2005-12-27
Source passage: el certificado de la entidad sanitaria que conste que se vende libremente en un país de referencia (Comunidad Económica Europea, Estados Unidos de Norte América, Canadá, Japón y Australia), o con los países en donde exista acuerdo de mutuo reconocimiento
Prior approval / evidence record
RTCR 505:2022 (Decreto Ejecutivo 43902-S) requires, for imported equipo y material biomédico, a Certificate of Free Sale as defined in numeral 4.7 (as amended by Decreto Ejecutivo 44431-S of 11 April 2024): a document issued by the competent authority of the country or region of origin certifying that the products are authorized for sale, use or distribution there, legalized or apostilled with official translation (numeral 11.3). For China-made devices an NMPA certificate is that document; it does not shorten the review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
costa-rica
NMPA Class I filings and Class II/III certificates for EMB classes 2, 3 and 4 (class 1 exempt from registration)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2023-09-09
Source passage: 4.7. Certificado de Libre Venta: Es el documento expedido por la autoridad competente del país o región de origen, en el cual se certifica que el producto o productos a que se refiere el certificado están autorizados para la venta, uso o distribución en el país o región de origen.
Prior approval / evidence record
Croatia is an EU member state: a device may be placed on the Croatian market only if it complies with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration certificate is not recognised by HALMED and opens no abridged, documentary, fast-track or reciprocal route; the holder must obtain CE marking through a notified body under MDR/IVDR before the device may lawfully be placed on the Croatian market. The only exception is a public-health derogation under Article 59 MDR / Article 54 IVDR, which Croatia implements nationally in Article 14 of NN 100/2018 and which authorises a specific device for a limited purpose; it is not recognition of a foreign approval.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Source is the English consolidated MDR text on EUR-Lex. Verbatim: "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." The IVDR equivalent is Article 5(1) of Regulation (EU) 2017/746. The Croatian implementing act's only gateway for a non-conforming device is Article 14 (national derogation).
Prior approval / evidence record
The retained official E 86-16 text, section 3.2.4, permits a current prior registration certificate from the origin country or a qualifying comparable regulatory programme (including IMDRF members) in place of specified software, biological, safety, raw-material and stability evidence. This is evidence reduction, not automatic Cuban approval. Section 4.1.2 restricts ordinary Proceder B eligibility to specified devices; China Class III does not itself establish eligibility. The regulation expressly excludes in vitro diagnostics. Current applicability still requires confirmation because the live official PDF could not be retrieved in this review.
china
nmpa
Current country-of-origin product registration certificate, including a qualifying NMPA Class II/III certificate for a China-made device
cuba
General medical devices only; excludes IVDs; Cuban risk class, novelty and sensitive-device rules must be checked separately
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2016-07-29
Retained official PDF SHA-256 ac391e2e881c7d576da7568b9618b658354d486bc845eda92e96cacd6cf0a8a3. Independent passage review completed 2026-09-15; live currentness not confirmed, so source-backed-partial is retained.
Regulatory reference
Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.
Effective from 2016-07-29
Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.
Regulatory reference
The cited 2023 policy refers to PAHO reference authorities, WHO-listed authorities and authorities covered by CECMED agreements. WHO subsequently included NMPA on its transitional medical-device list on 1 July 2026. Whether CECMED treats that transitional device listing as qualifying under its policy has not been established. Do not infer exclusion from the permanent medicines-authority list or from an incomplete list of cooperation instruments.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
cuba
all regulatory functions incl. device registration (reliance practice)
Eligibility Unresolved
undetermined
Product Marketing
Yes
Yes
Effective from 2023-10-09
Source passage: SEGUNDO: El CECMED aplicará la Confianza Reguladora a las decisiones y procesos de las Autoridades Nacionales Reguladoras de Referencia Regional certificadas por la Organización Panamericana de la Salud, las Autoridades Listadas por la OMS, así como aquellas Autoridades Reguladoras Nacionales con las que [...]
Prior approval / evidence record
Cyprus, as an EU Member State, operates no abridged, fast-track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or China NMPA approval cannot be placed on the Cypriot market: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are directly applicable and permit placing on the market only of a device that complies with them, and CYMDA's own description of how a manufacturer affixes the CE marking describes only the Union conformity assessment procedure, with no national pre-market approval step and no reference to any third-country approval.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2021-05-26
English source (Regulation (EU) 2017/745). The excerpt is the Union rule that governs placing on the Cypriot market. The Cypriot side of the same answer is CYMDA's conformity-assessment page (source res-cy-conformity-assessment), which describes only the Annex I essential-requirements plus notified-body route, and CYMDA's statement that it has imposed no additional requirement beyond Union and national law (source res-cy-importer-notice-2025). No Cypriot or Union instrument consulted names an FDA, PMDA, MFDS or NMPA approval as a basis for placing a device on the Cypriot market.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
czech-republic
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
denmark
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
From 28 January 2027, ARCSA-DE-2026-003 Article 25(a) accepts a Certificate of Free Sale (CLV), or qualifying equivalent, from the country of manufacture/export, a high-vigilance agency or an IMDRF member country. A China-issued document must itself satisfy the required declaration of marketing and product/manufacturer/site particulars; an NMPA registration certificate or Class I filing is not automatically a compliant CLV. This is documentary evidence for registration, not an automatic simplified-review benefit.
china
nmpa
China-issued Certificate of Free Sale or equivalent satisfying Article 25(a), not merely any NMPA certificate
ecuador
Imported devices within the regulation; qualifying free-sale documentation must be established for the particular product
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2027-01-28
Source passage: Se aceptará el CLV proveniente del país donde se fabrica o exporta, o proveniente de una Agencia de alta vigilancia, o de un país miembro del IMDRF.
Regulatory reference
From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high-vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device-scope authorisation and ARCSA risk classification I-IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.
Effective from 2027-01-28
Recognition opens a simplified procedure; it is not a full reliance approval.
Regulatory reference
For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high-vigilance agency, or from an IMDRF member country; if the CLV or the product-owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.
Effective from 2027-01-28
Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).
Regulatory reference
From 28 January 2027, Articles 31-32 require both high-vigilance authority status and IMDRF membership, plus the stated device marketing/class conditions. IMDRF membership alone is insufficient. NMPA appears on WHO's July 2026 transitional medical-device authority list, but ARCSA's treatment of this listing under its high-vigilance definition has not been established; the maintained evidence therefore does not resolve NMPA-only eligibility.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ecuador
NMPA Class II/III certificates; target ARCSA simplified registration (Arts. 31–34) for classes I–IV
Eligibility Unresolved
undetermined
Product Marketing
Yes
Yes
Effective from 2027-01-28
Source passage: Agencias de alta vigilancia. - Son autoridades reguladoras que han sido calificadas por la OPS / OMS como Autoridades de Referencia Regional; así como aquellas agencias consideradas como Autoridades Reguladoras Estrictas por la OMS. ... Art. 31.- La ARCSA, reconocerá el registro sanitario o su equivalente, proveniente de Agencias de alta vigilancia y que, a su vez, sean miembros del IMDRF.
Prior approval / evidence record
For non-sterile imported Class IIa devices EDA accepts, in the initial registration file, a free-sale certificate from the country of origin, and even one from a non-reference country, provided a reference-country free-sale certificate is filed within a 6-month grace period. This is the only point in GL.CAMD.002 at which an origin-country (e.g. Chinese, NMPA-based) marketing document has any evidentiary role; it grants no abridged review and lapses unless replaced by reference-country evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
egypt
Non-sterile Class IIa only (initial registration file)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2025-09-01
Source passage: The following documents are sufficient for the initial registration file: - Declaration of conformity - CE certificate - ISO 13485:2016 - Free sale certificate from a reference country in case of devices classified as Class II b, III. - Free sale certificate from the country of origin in case of devices classified as Class II a. * In the initial registration file: - For devices classified as Class IIa: It is sufficient to submit a free sale certificate from a non-reference country in case a free sale certificate is not available from one of the reference countries, provided that a free sale certificate from one of the reference countries shall be submitted within the grace period of (6 months).
Regulatory reference
EDA's device-registration guideline GL.CAMD.002 v2 (September 2025) enumerates the reference countries exhaustively (the EU/EEA states plus Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the UK and the USA) and China is not among them, so an NMPA certificate confers no reference-country status. A China-made device must submit the full Appendix 1 file (declaration of conformity, CE certificate from an EU notified body, ISO 13485:2016 for the actual manufacturer, and a free-sale certificate from a reference country because the country of origin is non-reference) and is routed to the relevant specialised scientific committee before registration, which may require published clinical trials, a stamped summary of market history in reference countries, and ILAC-accredited laboratory test reports depending on device type.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
egypt
All classes (I, IIa, IIb, III; sterile and non-sterile); NMPA Class I/II/III devices are treated as 'imported from a non-reference country'
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-09-01
Source passage: List of Reference Countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom and United States of America [...] Devices that are subjected to specialized scientific committees' evaluation as a step prior to registration are: • Devices submitted for new registration or re-registration, which are imported from non-reference countries or locally manufactured. [...] 1) The free sale certificate that is issued by the Ministry of Health of the country of origin if it is a reference country (or a free sale certificate from one of the reference countries if the country of origin is a non-reference country) [...] For medical devices imported from non-reference countries in all classifications (I, IIa, IIb & III), the following shall be provided: - clinical trials published in reputable scientific journals. - An approved and stamped Summary of market history from centers and hospitals where the device has been used in the reference countries.
Prior approval / evidence record
EFDA's SRA route enumerates exhaustively the foreign authorities whose marketing authorisation, registration certificate or free-sale certificate makes a device eligible (US FDA, Japan MHLW, Australia TGA, Singapore HSA, the 27 EU Member State competent authorities, UK MHRA, Health Canada, South Korea MFDS), plus WHO and UNFPA prequalification. China NMPA is not among them, so a device holding only an NMPA registration certificate is not eligible for the §9.4 shortened route and must be filed for full assessment. The NMPA certificate still has a documentary role, because every application must include a free-sale certificate or marketing authorisation certificate from the national regulatory authority where the device is marketable, which for a China-made device is the NMPA certificate.
China NMPA medical device registration certificate (Class II/III) or Class I filing record
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2026-06-25
Bounded claim: the cited passage enumerates the accepted authorities and states 'The list of Authorities that are recognized by the EFDA as Stringent Regulatory Authorities will be updated as deemed necessary.' China NMPA does not appear anywhere in the enumeration. Verbatim: 'At present, EFDA accepts the registration submissions as an SRA or prequalified products application if they're supported by one or more of the following document(s).' followed by the closed list of eight authorities plus WHO and UNFPA prequalification.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
eu
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
finland
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
france
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
germany
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
FDA Ghana's Guidelines for the Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01, Version 02, issued 1 March 2016) prescribe a full technical dossier (device description, evidence of conformity to Essential Principles via the Annex II checklist, materials, specifications, verification and validation, biocompatibility, clinical evidence, labelling) with no abridged route, no list of reference regulatory agencies and no requirement for a certificate of free sale or country-of-origin approval. A prior NMPA approval is therefore neither required nor recognised in the standard registration procedure; any credit for foreign approval arises only through the separate reliance guideline.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ghana
all classes under the device registration guideline (full dossier review)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2016-03-01
Source passage: 3.2 Evidence of Conformity to Essential Principles. Provide evidence of conformity to Essential Principles of Safety and Performance (EPSP) by completing the checklist appended as Annex II. [...] 3.5.1.7 Declarations/certificate of compliance to a recognized standard as applied by the manufacturer should be provided.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
greece
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
GN-06:2026 permits an NMPA registration certificate, with associated Product Technical Requirements where applicable, as a reference marketing approval supporting MDACS listing of Hong Kong Class B/C/D IVDs under D002. The Hong Kong class must be assessed separately. D003 requires the signed MDIVD-CCL; an EU ER/GSPR checklist is an alternative only with qualifying EU approval evidence. Local listing and remaining requirements still apply.
china
nmpa
NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable
hong-kong
NMPA-registered IVD; separately determine whether the product falls within Hong Kong Class B/C/D
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2026-07-31
Independent review of the current official PDF on 2026-09-15: D002 identifies Chinese Mainland NMPA registration certificates; D003 retains the essential-principles checklist. No automatic risk-class mapping or retired checklist exemption is established by these items.
Prior approval / evidence record
"Novo Lane" innovative device priority (GN-02 item E001)
Prioritised processing for first-of-its-kind devices, devices approved through another regulator’s innovation channel (NMPA 創新器械名錄, FDA De Novo) within 5 years, devices with AI features approved within 5 years, or devices whose core technology was patented within 5 years
Priority in the processing queue; MDD publishes no shorter target period, and the device still needs the same D001 or D002 evidence
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
GN-02:2026 D002 accepts an NMPA registration certificate, with associated Product Technical Requirements where applicable, as reference approval evidence for MDACS Class II/III/IV general-device listing. A003 also allows specified Chinese QMS documentation when accompanied by valid NMPA approval. E001 provides priority for eligible innovative devices, while E002 has additional conditions for expedited approval. These provisions do not grant automatic listing.
china
nmpa
NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable
hong-kong
NMPA Class II/III registration certificate (医疗器械注册证) -> MDACS Class II/III/IV general medical devices
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2026-07-31
Independent review of the current official PDF on 2026-09-15: D002 identifies Chinese Mainland NMPA registration certificates; D003 retains the essential-principles checklist. No automatic risk-class mapping or pre-2004 checklist exemption is established by these items.
Prior approval / evidence record
NMPA (Chinese Mainland)
Yes
Registration certificate satisfies D002; pairs with a GB/T 42061 certificate or manufacturing licence as QMS evidence
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
hungary
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
An approval from a non-EEA regulator gives no market-access route and no abridgement in Iceland. Act No. 132/2020 and the Regulations provide no reference-country fast track, no abridged review based on a foreign approval, and no acceptance of a foreign registration certificate in place of CE marking. A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be carried in the technical documentation as supporting evidence but substitutes for nothing: without CE marking and an EU declaration of conformity the device may not lawfully be placed on the Icelandic market.
none
No Reliance Route
none
Product Marketing
No
Yes
Effective from 2021-05-26
Verified negative. The Act states an exhaustive single condition for placing on the market (CE marking per Annexes IX–XI) and the Act and Regulations nowhere name a foreign regulator or a reference-country route; the agency's guidance likewise describes CE marking and the EU declaration of conformity as the route. The only non-CE access is the national exemption route in Article 9 and the Union derogations recorded under special-access-derogation, which are discretionary and are not recognition of a foreign approval.
Prior approval / evidence record
CDSCO and China's NMPA are both parties to the BRICS regulators' Memorandum of Understanding (together with ANVISA, the Russian Ministry of Health, Ministry of Industry and Trade and Roszdravnadzor, and SAHPRA), listed by CDSCO as valid until 31 January 2029. The instrument is a cooperation MoU and creates no recognition of NMPA approvals in India.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
india
Not class-specific; regulatory-cooperation instrument only
Cooperation Mou
none
Product Marketing
Yes
Yes
Source passage: 04 BRAZIL, RUSSIA, INDIA, CHINA, SOUTH AFRICA (BRICS) Memorandum of Understanding (MoU) ... The Central Drugs Standard Control Organization of The Republic of INDIA (CDSCO) ... The National Medical Products Administration of The People's Republic of CHINA (NMPA) ... 31.01.2029
Prior approval / evidence record
For devices imported from countries outside the rule 36(3) list, Class C and D licences may be granted only after safety and effectiveness are established through clinical investigation in India, and Class A and B licences after published safety and performance data or a clinical investigation in the country of origin plus a free sale certificate from the country of origin. A China NMPA registration certificate or the NMPA-based free sale certificate therefore serves only as the country-of-origin documentary evidence required with Form MD-14/MD-15; it gives no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
india
NMPA Class II/III certificate or Class I filing used as country-of-origin evidence; Indian Class A/B (rule 36(5)) and Class C/D (rule 36(4))
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2018-01-01
Source passage: (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in case of Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished.
Regulatory reference
Rule 36(3) of the Medical Devices Rules, 2017 grants the import licence without an Indian clinical investigation only where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country or the United States (the United Kingdom was added by amendment in 2022). China/NMPA is not on the list, so an NMPA registration certificate does not trigger the clinical-investigation waiver.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
india
All NMPA classes; concerns Indian import licence (Form MD-15) for Class A-D devices
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2018-01-01
Source passage: (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation.
Regulatory reference
PMK 5/2026 Pasal 58(4) requires the Indonesian izin edar before importing medical devices and PKRT, subject to the applicable exceptions. This establishes a local permit requirement. It does not determine whether reliance, evidence reuse or an abridged assessment may be available in obtaining that permit; the cited clause alone cannot support a country-wide finding that NMPA evidence has no benefit.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
indonesia
Medical devices and PKRT within Pasal 58; local classification and application pathway require separate assessment
Eligibility Unresolved
undetermined
Product Marketing
Yes
Yes
Effective from 2026-05-04
Independent review of PMK 5/2026, Pasal 58(4)-(5) and 62, from the Ministry JDIH PDF; source-backed-partial reflects unresolved NMPA pathway eligibility.
Prior approval / evidence record
IMED's import registration file requires a sales/free-sale certificate in the country of manufacture in addition to CE/FDA/Japan approval. For a device manufactured in China this country-of-manufacture requirement can be met with the NMPA registration certificate or China free-sale documentation, but this is purely documentary evidence and provides no abridged or reliance review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
iran
NMPA Class II/III registration certificate (and Class I filing) as country-of-manufacture sales evidence for China-made devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Source passage: ارائه تاییدیه های معتبر بین المللی CE، FDA و یا تاییدیه ژاپن ... گواهی فروش در کشور سازنده. سابقه فروش در اتحادیه اروپایی، آمریکا و یا ژاپن (برای اقلام کلاس C و D)
Regulatory reference
IMED's device registration directive requires imported devices to present valid international approvals from CE (notified bodies of IMED-accepted rank), US FDA (510(k)/PMA plus registration) or Japan, together with a sales certificate in the country of manufacture. The country-of-manufacture scoring table places the USA, Germany and Japan in G1, listed European states, Canada and Australia in G2, South Korea and other European countries in G3, and 'all other countries' in G4 with zero points. China/NMPA is not among the accepted approval authorities or named country groups, so an NMPA certificate carries no reliance value, and devices made in G3/G4 countries face mandatory ISO 13485 evidence (classes A/B) and pre-registration production-line audits (classes C/D).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
iran
NMPA Class I/II/III; all imported devices (IMED risk classes A-D)
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: ارائه تاییدیه های معتبر بین المللی CE، FDA و یا تاییدیه ژاپن. توجه: ارائه تاییدیه CE صرفا از NB های رتبه 1، 2 و یا 3 مورد قبول ... گواهی فروش در کشور سازنده ... امتیاز دهی بر اساس کشور سازنده اصلی G1 30 G2 20 G3 10 G4 0 ... کشورهای G3: کره جنوبی، سایر کشورهای اروپایی؛ کشورهای G4: سایر کشورها ... ارائه گواهی مطابقت با استاندارد ISO13485 از نهاد ذیصلاح برای کلاس A و B که در کشورهای G3 و G4 تولید می شوند، الزامی است. برای تجهیزات و ملزومات کلاس C و D که در کشورهای G3 و G4 تولید می شوند، ممیزی خط تولید قبل از ثبت الزامی
Regulatory reference
KIMADIA tenders 55/2023/84 and 55/2023/85 for the national hemodialysis project specify FDA/CE quality evidence for the covered equipment. This dated tender document does not establish the requirements of every Iraqi procurement or private-sector registration. Its Arabic/English wording also differs at item 2, so the procurer should resolve the exact tender requirement.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
iraq
Equipment covered by these two 2023 dialysis tenders only
Eligibility Unresolved
undetermined
Public Procurement
Yes
Yes
Source passage: على ان تكون الاجهزة حاصلة على شهادات (FDA or CE) ومصنعة من قبل شركات عالمية رصينة وحسب المواصفات الفنية المعتمدة من قبل دائرة الامور الفنية / قسم ادارة الاجهزة الطبية ... 34- تكون الاجهزة الطبية الاساسية والملحقة والاجهزة المختبرية حاصلة على شهادة الجودة (FDA or CE).
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ireland
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
The cited AMAR procedure requests regulatory evidence from recognised states for its recognised-state pathway. This does not establish that a China-made device is legally barred from the ordinary assessment route without FDA/CE approval. Confirm the current ordinary-route procedure and product scope before concluding whether NMPA-only evidence is eligible.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
israel
NMPA Class II/III certificates and Class I filings; AMAR regular track for imported devices of all risk classes
Eligibility Unresolved
undetermined
Product Marketing
Yes
Yes
Effective from 2025-01-01
Source passage: אישורים רגולטורים (אישורים ממדינות מוכרות (עפ"י חוק הציוד הרפואי) ... FDA אישורים רגולטוריים של ה-FDA (למשל 510K, PMA, CTFG, Reg. & Listing) ... CE אישורים רגולטוריים ממדינות מוכרות באירופה ... DOC הצהרת תאימות לדרישות ... אישורים רגולטוריים ממדינות מוכרות אחרות (למשל: קנדה, אוסטרליה, וכו') || Q&A: עבור מוצר שאיננו רשום ומשווק במדינה מוכרת יש להגיש בקשה לרישום במסלול הרישום הרגיל.
Regulatory reference
Israel's Medical Equipment Law 5772-2012 defines a 'recognized state' (מדינה מוכרת) as any state listed in the First Addendum, and section 6(b) grants the abridged recognized-state registration only to devices registered or marketed in such a state. The First Addendum enumerates 21 states exhaustively and China is not among them, so an NMPA registration certificate does not qualify a device for the recognized-state route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
israel
All NMPA classes (Class I filing, Class II/III registration); relevant to all Israeli risk classes and tracks
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2013-09-10
Source passage: "מדינה מוכרת" — כל אחת מהמדינות המנויות בתוספת הראשונה ... תוספת ראשונה (סעיף 1, ההגדרה "מדינה מוכרת") רשימת המדינות המוכרות: 1. אוסטריה; 2. אוסטרליה; 3. איטליה; 4. איסלנד; 5. אירלנד; 6. ארצות הברית; 7. בלגיה; 8. בריטניה; 9. גרמניה; 10. דנמרק; 11. הולנד; 12. יוון; 13. נורווגיה; 14. ניו–זילנד; 15. ספרד; 16. פורטוגל; 17. פינלנד; 18. צרפת; 19. קנדה; 20. שבדיה; 21. שוויץ.
Prior approval / evidence record
On 8 December 2020 NMPA Commissioner Jiao Hong and Israel's Ambassador to China (on behalf of the Israeli Minister of Health) signed a Joint Declaration of Intent on cooperation in the regulation of drugs, medical devices and cosmetics between NMPA and the Israeli Ministry of Health. The instrument is a cooperation-intent declaration only; it contains no mutual recognition or reliance on NMPA registrations, and Israel's recognized-state list was not amended as a result.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
israel
Drugs, medical devices and cosmetics (regulatory cooperation; no product-class scope)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2020-12-08
Source passage: 2020年12月8日上午，国家药监局局长焦红与以色列驻华大使何泽伟在京签署了《中华人民共和国国家药品监督管理局与以色列国卫生部关于药品、医疗器械和化妆品监管领域合作意向联合声明》（以下简称《联合声明》），旨在进一步促进双方药品、医疗器械和化妆品监管交流与合作。
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
italy
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
Japan's only foreign-approval-linked mechanism for devices is priority processing under PMD Act Art. 23-2-5(9) for devices already approved in a country designated by Cabinet Order as having an approval system of equivalent standard to Japan's. Enforcement Order Art. 37-26, as amended by Cabinet Order No. 362 of 2025 effective 1 May 2026, designates only the United States for medical devices and IVDs; China/NMPA is not designated. All devices still require Japanese approval, certification or notification following full review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
japan
All device and IVD marketing approvals (承認); NMPA approval carries no procedural benefit
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-05-01
Source passage: 法第二十三条の二の五第九項第一号の政令で定める国は、専ら動物のために使用されることが目的とされている医療機器又は体外診断用医薬品以外の医療機器又は体外診断用医薬品の製造販売の承認については、アメリカ合衆国とする。
Regulatory reference
JFDA's binding circulation rules (Annex 1, item 4) require the registration file to contain ONE of an exhaustively listed set of conformity credentials: an FDA Certificate to Foreign Government, an FDA 510(k), a CE certificate from an EU Notified Body, a Japanese MHLW free-sale certificate, or a country-of-origin free-sale certificate paired with a free-sale certificate from Switzerland, Australia, Canada, Norway or the United Kingdom. China/NMPA is not among the listed authorities, so an NMPA registration certificate alone does not satisfy the requirement and confers no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
jordan
All imported medical supplies/devices subject to JFDA registration (Class I sterile/measuring, IIa, IIb, III, active implants); NMPA Class I/II/III alike
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2019-04-01
Source passage: ٤- النسخة الأصلية أو نسخة مختومة ختماً أصلياً من كاتب العدل في بلدها (Notary Public) أو من غرفة الصناعة والتجارة أو أي جهة رسمية معتمدة في بلد المنشأ ... لأي من الشهادات التالية: ٤:١ شهادة FDA المسماة (Certificate to Foreign Government) ... ٤:٢ شهادة 510 K ... ٤:٣ شهادة CE صادرة عن جهة معتمدة لدى دول الاتحاد الاوروبي والمعروفة بـ Notified body ... ٤:٤ شهادة حرية بيع من اليابان صادرة عن Ministry of Health & Welfare Labour. ٤:٥ شهادة حرية بيع (Free Sale Certificate) من جهة رسمية في بلد المنشأ بالإضافة إلى شهادة حرية بيع من أي من الدول التالية: (سويسرا، استراليا، كندا، النرويج، المملكة المتحدة) في حال كون منشأ المستلزمات الطبية من غير هذه الدول
Prior approval / evidence record
Where a device is made in a country outside the named list, JFDA accepts a free-sale certificate from an official body in the country of origin as part of the file, but only when supplemented by a free-sale certificate from Switzerland, Australia, Canada, Norway or the UK. An NMPA-based Chinese FSC is thus admissible origin evidence but must state that the device is freely sold in China, carry a validity period, name the manufacturer/marketing-rights holder and site, and be accompanied by one of the five listed countries' FSCs; no abridged review follows.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
jordan
All imported medical supplies/devices not holding FDA CFG/510(k), CE or Japanese FSC, i.e. the typical position of an NMPA-only device
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2019-04-01
Source passage: ٤:٥:١ أن تنص على أن المستلزمات الطبية مسموح ببيعها في بلد المنشأ وتعتمد أي من الصيغ التالية: تسوق بحرية Freely marketed ... ٤:٥:٢ ان تحمل مدة صلاحية (Validation time) وبخلاف ذلك تعتبر مدة صلاحية الشهادة خمس سنوات من تاريخ اصدارها. ٤:٥:٣ أن تذكر اسم الشركة الصانعة أو الشركة مالكة حق التسويق وموقع التصنيع.
Prior approval / evidence record
Under the national expertise rules, the registration dossier for any foreign-made device must contain a document certifying registration in the country of the manufacturer or production site (registration certificate, free-sale certificate or export certificate) with Kazakh and Russian translation. For a China-made device the NMPA registration certificate or NMPA-based export/free-sale certificate is that document; it triggers no abridged expertise.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kazakhstan
All classes (1, 2a, 2b, 3 and IVDs) under the national registration route
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2021-02-06
Source passage: 1. Документ, удостоверяющий регистрацию в стране производителе или производственной площадке (регистрационное удостоверение, или Сертификат свободной продажи (FreeSale), или Сертификат на экспорт) с аутентичным переводом на казахский и русский языки (за исключением медицинских изделий, произведенных в Республике Казахстан) + + + + +
Prior approval / evidence record
The EAEU registration dossier includes, where available, a copy of the registration certificate (free-sale certificate or export certificate) issued in the manufacturer's country, and information on registration in other countries. An NMPA certificate for a China-made device is submitted under this item; it is optional ('при наличии') and does not shorten the EAEU expertise.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kazakhstan
All classes under the EAEU common registration route (Council Decision No. 46)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2016-02-12
Source passage: 10. Копия регистрационного удостоверения медицинского изделия (сертификата свободной продажи, сертификата на экспорт (за исключением медицинских изделий, впервые произведенных на территории государства-члена)), выданного в стране производителя (при наличии) ... 11. Сведения о регистрации в других странах ... или копия документа, удостоверяющего регистрацию медицинского изделия в других странах (при наличии)
Regulatory reference
PPB's abridged, expedited (EBR/ECR/EDR) and immediate (IBR) evaluation routes are available only to devices already approved by PPB's listed medical-device reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVDD certificates), Japan MHLW, US FDA (510(k) or PMA; 510(k)-exempt products excluded), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. China NMPA is not among the eight agencies, so an NMPA registration certificate does not qualify a device for any abridged route; a device with no reference-agency approval goes to the full evaluation route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kenya
NMPA Class II/III certificates and Class I filings; target Kenya Class B, C and D (abridged, expedited and immediate routes)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2021-08-01
Source passage: Table 2: Types of marketing clearances or approvals from each country/region — 1. Australia: Australia Therapeutic Goods Administration (TGA) license; 2. Canada: Health Canada License; 3. European Union (EU) [...]; 4. Japan: Ministry of Health, Labour and Welfare (MHLW) License; 5. United States of America (USA): US FDA 510(K) clearance letter [510(K) exempted products do not qualify for abridged evaluation route.]; or US FDA PMA approval letter; 6. Ireland: Irish Health Products Regulatory Authority; 7. Saudi Arabia: Saudi Arabia Food and Drugs Authority; 8. Switzerland: Swiss Medic. [...] A medical device that has not obtained any prior approval from any of PPB's reference regulatory agencies at the point of application will be subject to the full evaluation route.
Regulatory reference
PPB's Guidelines on Reliance Mechanisms (HPT/PER/GUD/091 Rev 0, January 2025) enumerate the reference authorities and institutions PPB relies on: WHO PQ/CRP/EUL, SRAs, WHO Listed Authorities, WHO transitional WLAs (Category A ML3/ML4 NRAs for vaccines, B SRA, C highly performing NRA for vaccines), continental and regional harmonisation bodies, EMA Article 58/Swissmedic MAGHP, NRAs with a PPB MoU at WHO ML3 or above, and 'Member of the International Medical Devices Regulators Forum as a founding member country'. China NMPA is not an SRA, not a WLA, and not an IMDRF founding member, so its decisions are not within PPB's recognised reference set.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kenya
all health products and technologies incl. medical devices and IVDs (reliance pathways)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-01-01
Source passage: e) WHO Listed Authorities (WLAs)/SRA f) WHO Transitional WLAs (Category A, B and C)- Category A - ML3 & ML4 NRAs for vaccines only, Category B- SRA and Category C- Highly performing NRA (Vaccines) [...] j) Member of the International Medical Devices Regulators Forum as a founding member country. Note: The list of Reference Regulatory Authorities shall be reviewed from time to time based on WHO updates of WLA, changes in regulatory environment and adoption of best practices.
Prior approval / evidence record
For listing of Class A medical devices PPB requires, among the submission documents, 'Regulatory approval from the country of origin of the product' together with proof of a quality management system. For a device made in China this documentary requirement is met by the NMPA registration certificate or Class I filing record; the requirement is evidentiary only and confers no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kenya
NMPA Class I filing (备案) or Class II/III certificate as country-of-origin evidence; target Kenya Class A listing
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2021-08-01
Source passage: 8. Regulatory approval from the country of origin of the product. 9. Proof of Quality Management System (QMS) – E.g. ISO 13485 certificate, conformity to US FDA Quality System Regulations (Certificate of free sale), Japan MHLW Ordinance 169 or attestation stating adequate QMS, CE Certificate from the EU/UK IRELAND
Prior approval / evidence record
Latvia operates no abridged, fast-track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or China NMPA approval cannot be placed on the Latvian market: the Latvian pre-market notification procedure (paziņošanas procedūra) requires a copy of the EU declaration of conformity and copies of valid notified-body certificates issued under Regulation (EU) 2017/745, and no Latvian or Union instrument names a third-country approval as a basis for market access.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2023-08-23
Latvian source; translation: '9. Persons who in the territory of the Republic of Latvia start placing on the market class IIa, IIb and III medical devices shall submit to the agency a completed notification form (Annex 1) and attach a copy of the EC (EU) declaration of conformity, as well as copies of valid certificates issued by notified bodies (hereinafter - the notification procedure).' The excerpt shows that the only Latvian pre-market procedure is conditioned on EU documentation, i.e. on CE marking; the Union-side rule that a device may be placed on the market only if it complies with the Regulation is evidenced by the separately declared source res-lv-mdr (Article 5(1), Article 52(1)). No Latvian or EU instrument consulted names FDA, PMDA, MFDS or NMPA approval as a market-access basis.
Prior approval / evidence record
The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre-2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and class IIb implantable devices other than certain well-established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit because it is not a Directive certificate.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2023-03-20
English source. The excerpt is quoted from the amending act; the inserted text uses the defined terms of Regulation (EU) 2017/745 / 93/42/EEC / 90/385/EEC and names no third-country approval.
Prior approval / evidence record
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
Yes
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For products whose countries of origin are other than the European Union, the USA, Canada, Australia and Japan, the accepted conformity document is a certificate of conformity of the manufacturer's quality management system to ISO 13485, in place of a reference-authority approval certificate. This is the documentary channel through which a device carrying only a Korean MFDS or Chinese NMPA approval can be filed, together with the manufacturer's authorisation for the local distributor.
Korea MFDS; China NMPA; any other authority outside the EU, USA, Canada, Australia and Japan
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Un certificat de conformité à la norme ISO 13485 du système de gestion de la qualité du fabricant pour les produits dont les pays d'origine sont autres que l'Union Européenne, USA, Canada, Australie et Japon." Translation: "A certificate of conformity to the ISO 13485 standard for the manufacturer's quality management system, for products whose countries of origin are other than the European Union, USA, Canada, Australia and Japan."
Prior approval / evidence record
A Korean MFDS, Chinese NMPA or other approval from outside the GHTF reference set is named in neither the closed five-jurisdiction conformity list nor the GHTF conformity requirement, and it opens no abridged or recognition route. The procedure instead provides a distinct evaluation track for medical devices that have no approval obtained from one of the regulatory authorities of the GHTF countries, so such a device is assessed on its own dossier rather than through reliance.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Evaluation des dispositifs médicaux qui n'ont pas d'approbation obtenue de l'une des autorités réglementaires des pays de la GHTF." Translation: "Evaluation of medical devices that do not have an approval obtained from one of the regulatory authorities of the GHTF countries." This is the procedure's own separate step for devices lacking a GHTF-authority approval; read with section 6.3 provision 24, whose list of jurisdictions is closed.
Prior approval / evidence record
In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.)
Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2014-02-18
Source language Arabic; the PDF is a scan with no text layer and the text was recovered by OCR (pdftoppm -r 300 -png + tesseract -l ara+eng), so the wording is an OCR reading and Arabic-Indic digits are unreliable — hence source-backed-partial. OCR original: "إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government صادرة عن احدى الدول المنتمية الى مجموعة IMDRF (International Medical Devices Regulators Forum) اي انها تباع في واحدة من هذه الدول مهما كان منشؤها." Translation: "In addition to the documents required under Article Six of Decision No. 455/1 of 16/4/2013, the registration application shall be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum); that is, that it is sold in one of these countries, whatever its origin." The article number (المادة الرابعة, Article Four) is legible in the OCR.
Prior approval / evidence record
Korea MFDS, China NMPA and other non-reference approvals, and the manufacturer's ISO 13485 certificate as the documentary route for goods from other origins
No
Not accepted as a reference authorisation: Decision 455/1 Art. Six lists the European Union, the United States, Switzerland, Australia, Canada and Japan, and Decision 1506/1 Art. Four the GHTF/IMDRF group, but neither names Korea or China. A device made in or imported from a country outside that list follows the Industrial Research Institute's certificate against Lebanese or international reference specifications, with the manufacturer's ISO 13485 certificate accepted as evidence in the service records for sterile instruments and reagents — a documentary route that carries no recognition and shortens no period.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
liechtenstein
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
lithuania
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
luxembourg
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
Law 12/2025 makes prior registration or marketing authorisation in the place of manufacture a legal precondition for registering (Class IIb/III) or filing (Class I/IIa) any foreign-made device in Macau, unless the device is made in a region designated by Chief Executive dispatch (currently the Hengqin Cooperation Zone). An NMPA registration certificate or Class I filing therefore satisfies this documentary prerequisite for Mainland-manufactured devices, but ISAF still conducts its own review of safety, efficacy and quality controllability and issues its own registration certificate; the law creates no Mainland-specific abridged or recognition channel. Separately, Article 12 designates PRC mandatory national standards as an accepted quality standard.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
macau
All classes (I, IIa filing; IIb, III registration); NMPA Class I filing / Class II-III registration certificates satisfy the origin-authorisation prerequisite for Mainland-made devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2026-07-01
Source passage: 二、如屬在外地製造的醫療器械，為在澳門特別行政區註冊或備案，須在外地已註冊或取得銷售許可，但屬公佈於《公報》的行政長官批示訂定的地區製造的醫療器械除外。
Prior approval / evidence record
Following the 2025 IVD reliance pilot (Phase 1, held), MDA and NMPA launched Pilot Phase 2, the Malaysia-China Joint Evaluation Pilot Programme, from 1 July to 30 September 2026 under the GHWP Common Evaluation Reliance Practice (CERP) framework. Phase 2 replaces one-way reliance with simultaneous, collaborative assessment by both regulators of devices not yet registered in either country: Chinese manufacturers submit to NMPA under its Special Channel Pilot Programme and Malaysian manufacturers submit to MDA for full conformity assessment, with each authority evaluating and issuing its own certificate. This is not a pathway for a product that already holds a China NMPA registration certificate.
china
nmpa
No prior registration certificate in either China or Malaysia (eligibility prerequisite)
malaysia
China-made NMPA Class II or III general medical devices and IVDs (via NMPA 'Special Channel Pilot Programme'); Malaysian-made Class B/C/D GMD and IVDs (via MDA full conformity assessment)
Bilateral Programme
none
Product Marketing
Yes
Yes
Effective from 2026-07-01 · Effective until 2026-09-30
Source passage: The second phase introduces a Joint Evaluation approach. Unlike the previous reliance model, this phase enables collaborative, simultaneous assessment by both the MDA and NMPA. ... Device Classes: Class B, C, or D (GMD or IVD) [Malaysian-Made] / Class II or Class III (GMD or IVD) [China-Made]. Prior Registration Status: The device must not have obtained registration certificates in Malaysia or China.
Regulatory reference
Outside the time-limited bilateral pilots, MDA's verification route (abbreviated CAB conformity assessment) is available only for devices holding a qualifying approval from the authorities enumerated in MDA/GD/0070 Annex 1 Table 5: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, US FDA, UK MHRA, Singapore HSA and Thai FDA. China's NMPA is not in the table, so an NMPA-only device must undergo full conformity assessment.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
malaysia
Class B/C/D devices and IVDs under the standard conformity-assessment-by-verification route; NMPA approvals not eligible
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-10-13
Source passage: Types of approvals eligible for conformity assessment by way of verification process
Regulatory reference
Pilot Phase 1 (30 July - 30 September 2025) under the MDA-NMPA MoU: Chinese-made IVDs (Class II approved by Provincial MPA or Class III by NMPA, manufacturer owning its China facility) are eligible for Malaysia's verification pathway, and Malaysian-made IVDs (Class B, C or D approved by MDA) are eligible for China's green channel; up to 6 applications per side, priority for rare-disease and innovative devices.
Effective from 2025-07-30 · Effective until 2025-09-30
Prior approval / evidence record
Malta gives no market-access route, abridged review or recognition to a US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration. The only pre-market route onto the Maltese market is the EU conformity assessment under Regulation (EU) 2017/745 (MDR) Annexes IX to XI — Regulation (EU) 2017/746 (IVDR) for IVDs — followed by CE marking; S.L. 458.59 defines a 'medical device' solely by reference to those two Union Regulations, so the national regime has no approval of its own that a third-country clearance could feed. A holder of only a third-country approval must obtain a CE certificate (or use the MDR Art. 59 / IVDR Art. 54 public-health derogation) and appoint an EU authorised representative.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2021-05-26
Verbatim passage supports the mandatory-and-exclusive character of the EU conformity route. Regulation (EU) 2017/746 Art. 48(1) is identically worded for IVDs (source res-eu-ivdr-2017-746): 'Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.' Neither Regulation contains any provision recognising, or providing an abridged route on the basis of, a third-country marketing authorisation of the kind issued by FDA, PMDA, MFDS or NMPA; that absence is the basis of this fact rather than a quotable clause.
Prior approval / evidence record
A China NMPA registration certificate or Class I filing gives no market-access route in Malta. Regulation (EU) 2017/745 Art. 52(1) (and Regulation (EU) 2017/746 Art. 48(1) for IVDs) requires the manufacturer to complete the EU conformity assessment in Annexes IX to XI before placing the device on the market; the Regulation contains no reliance or abridged procedure based on a third-country marketing authorisation, so the NMPA certificate is not assessed and the Chinese manufacturer needs a CE conformity route plus an EU authorised representative.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
malta
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2021-05-26
Verbatim source passage. The Maltese national instrument adds nothing: S.L. 458.59 reg. 2 defines 'medical device' by reference to MDR Art. 2(1) and IVDR Art. 2(2) only, so the national regime recognises no third-country approval category.
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
On 21–22 April 2021 COFEPRIS Commissioner Alejandro Svarch and NMPA Commissioner Jiao Hong signed, virtually, the 'Acuerdo entre la NMPA de la República Popular China y la Secretaría de Salud de los Estados Unidos Mexicanos sobre cooperación regulatoria de productos médicos'. Per Mexico's Foreign Ministry, both agencies undertake to take into account the registration information issued by the counterpart as a reference for registration in their own country, in line with applicable national law, to exchange information and to explore acceptance of GMP inspection results. It is a cooperation agreement; it does not itself create an abridged route, which now flows from the 2025 Lineamientos.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
mexico
Vaccines, medicines and medical devices/equipment (framework agreement)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2021-04-21
Source passage: The agreement stipulates that both regulatory agencies will take into account the registration information issued by their counterpart as a reference for registration in their own country, in line with the applicable national legislation.
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.
Effective from 2025-07-19
Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.
Prior approval / evidence record
The 2025 Lineamientos Article 24(I) recognises decisions of IMDRF Management Committee authorities for medical devices. NMPA is a committee member, so its qualifying product registration can support the COFEPRIS-04-050 equivalence application under Article 26(II), subject to the dossier in Article 31 and the Mexican decision. Article 24(II) separately addresses GMP certificates from MDSAP full members; IMDRF membership does not establish that a particular Chinese GMP document satisfies the GMP requirement.
china
nmpa
Qualifying NMPA Class II/III medical-device registration certificate
mexico
NMPA Class II and Class III registration certificates (medical devices and IVDs); target COFEPRIS registro sanitario of any class via COFEPRIS-04-050
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Solicitud de Registro Sanitario de Dispositivos Médicos por Equivalencia de Autoridades Regulatorias de Referencia (COFEPRIS-04-050)
Source passage: ARTÍCULO 24.- Para dispositivos médicos, la COFEPRIS reconoce las decisiones de las Autoridades Reguladoras de Referencia de: I. Países miembros del Management Committee del International Medical Device Regulators Forum (IMDRF); y, II. Miembros plenos del Programa de Auditoría Única de Dispositivos Médicos (MDSAP por sus siglas en inglés), para Certificados de Buenas Prácticas de Fabricación.
Prior approval / evidence record
FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
No
Mongolia recognises none of them and names none of them. Art. 33.2 requires the Agency to take into account that the device has been placed on the market in its country of manufacture, Order A/136 §3.6 permits the foreign risk grade to be considered, and Annex Two §§3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate — but no authority, country or reference list appears anywhere in the Law, in Order A/206 or in Annex Two, the foreign element is evidence of origin-country market placement rather than a recognised authorisation, no clock is shortened, and the Medical Devices Council still takes the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Myanmar FDA's import-recommendation document list for Class B, C and D devices requires Evidence of Marketing Approval from abroad, such as an export certificate, free-sale certificate or marketing history. An NMPA registration certificate or NMPA-issued export sales certificate for a China-made device meets this item; it is supporting evidence only and DFDA retains its own decision with no abridged pathway.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
myanmar
Class B, C and D import recommendation applications; NMPA Class II/III certificate or NMPA export/free-sale certificate serves as 'Evidence of Marketing Approval from abroad'
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Source passage: Evidence of Marketing Approval from abroad (export certificate / free sale certificate / marketing history) - item 11 as recorded in the held extraction
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
netherlands
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
New Zealand has no pre-market approval system for medical devices: there is no mandatory requirement for a device to be approved by any regulator before supply, and WAND notification does not imply any Medsafe assessment. A China NMPA certificate therefore has no regulatory role; the sponsor simply notifies the device to WAND and meets Medicines Act, labelling, advertising and post-market obligations.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
new-zealand
All classes
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2004-01-01
Source passage: There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand. Notification to the WAND database does not mean or imply that a medical device has been assessed by Medsafe in terms of quality, safety, efficacy, or performance.
Prior approval / evidence record
NAFDAC's Guidelines for Registration of Medical Devices in Nigeria (VBM-R&RA-GDL-001-00, effective 4 November 2024) require, for imported devices, a Certificate of Manufacture and Free Sale issued by the relevant health/regulatory body in the country of manufacture and authenticated by the Nigerian Embassy, and the notarised declaration lists a 'Manufacturing license / Certificate for companies from India and China' authenticated by the Nigerian Mission. An NMPA registration certificate / export certificate therefore serves as country-of-origin evidence for China-made devices, but NAFDAC still performs full documentation review, GMP inspection of the factory abroad, laboratory testing and FDRC approval (120 working days).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
nigeria
NMPA Class I filing or Class II/III certificate and Chinese manufacturing licence as documentary evidence; target all imported devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2024-11-04
Source passage: 3.5 Certificate of Manufacture and Free Sale (for imported medical devices). The manufacturer must show evidence that the company is licensed to manufacture medical devices and that the sale of the product does not constitute a contravention of the laws of that country, i.e., Free Sale Certificate (Certificate of Manufacture and Free Sale). The Free Sale Certificate should: 3.5.1 Be issued by a relevant Health/Regulatory body in the country of manufacture. [...] c. Manufacturing license / Certificate for companies from India and China and the authentication thereof by the Nigerian Mission in the country of origin
Regulatory reference
NAFDAC's Reliance Procedure applies to drugs, vaccines and medical devices including IVDs whose quality, safety and efficacy/performance have been confirmed by a Stringent Regulatory Authority 'as per WHO definition/classification' or by an authority with which NAFDAC has a reliance agreement (WAHO, AMRH, Swissmedic MAGHP). The guideline's SRA definition is closed: ICH members before 23 October 2015 (US FDA, European Commission, Japan MHLW/PMDA), ICH observers before that date (EFTA/Swissmedic, Health Canada) and MRA-associated authorities (Australia, Iceland, Liechtenstein, Norway). China NMPA is not an SRA, is not a WHO Listed Authority and has no reliance agreement with NAFDAC, so an NMPA certificate cannot open the reliance pathway.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
nigeria
NMPA Class II/III certificates; target all NAFDAC-registered devices incl. IVDs (reliance procedure)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-09-25
Source passage: Stringent Regulatory Authority (SRA): is defined as a well-resourced authority as defined by the WHO that is: a. a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission, and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or b. an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swissmedic and Health Canada; or c. a regulatory authority associated with an ICH member through a legally binding, mutual recognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway.
Prior approval / evidence record
An approval from a regulator outside the European Union gives no market-access route and no abridgement in North Macedonia. The Law recognises conformity assessment only through institutions recognised in the European Union or bodies authorised by the Minister of Health, and the device registration rulebook distinguishes only between devices that hold an EC certificate and devices that do not. A US FDA 510(k) clearance or PMA approval, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be placed in the technical documentation as supporting material but substitutes for nothing: without the EC certificate or EC declaration of conformity the full quality, safety and efficacy dossier under Article 8 of the 151/10 rulebook applies, together with an Agency opinion on efficacy.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Verified negative. Macedonian. Article 118(1) is exhaustive in form ('Постапката за оцена на сообразноста на медицинските средства се врши: … или …'). The same conclusion is reached on the origin-country side: the free-sale certificate is required from the manufacturer's own country whatever that country is, which shows the Law is not operating a reference-country recognition list. FDA, PMDA, MFDS and NMPA were searched for in the consolidated Law and in the device rulebooks and appear nowhere.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
norway
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
Oman's Class C&D registration guideline lets the applicant declare the regulatory jurisdiction the device follows, with an open 'Others (specify)' option, and requires in Section 10 a free sale certificate from the competent authority in the country of origin. A Chinese manufacturer can therefore file under 'Others' with NMPA-based origin evidence (NMPA registration certificate / China free-sale certificate), but the guideline defines product-certificate expectations only for the EU and US routes and offers no abridged review for NMPA approval.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
oman
Class C (IIb/III) and Class D (other III/IV/AIMD) medical devices, i.e. NMPA Class II/III devices falling in Oman's C/D bands
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2025-11-18
Source passage: Regulatory jurisdiction the device follows: • KSA (MDMA) • USA • EU • Canada • Australia • Japan • Others (specify) [...] Submit free sale certificate from competent authority in origin country or certificate of foreign government CFG if the product from USA and CDNE (certificate for medical device not exported from the United States).
Prior approval / evidence record
The import application forms require a free sale certificate from the country of origin attested by the Embassy of Pakistan as a mandatory document, and separately ask whether the product is on free sale in a rule 67 reference country. For a China-made device the NMPA-based free sale/export certificate satisfies the country-of-origin item; it does not satisfy the reference-country item and gives no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
pakistan
NMPA Class I filing / Class II-III certificate used as country-of-origin free-sale evidence; Pakistan Class A enlistment (Form 6-A) and Class B-D registration (Form 7-A) for import
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2018-01-16
Source passage: (xiii) Original Agency agreement from Market authorization Holder duly notarized from the country of origin. (xiv) Free sale certificate in the country of origin duly attested by Embassy of Pakistan. (xv) Whether the product is available on free sale in reference countries provided in rule 67 of Medical Devices Rules, 2017, Please attach original and valid free sale certificate duly attested by embassy of Pakistan.
Regulatory reference
The Medical Devices Rules, 2017 reference-country clause names the USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the United Kingdom, plus WHO-prequalified devices and CE-marked devices certified by NANDO-listed bodies. China/NMPA is not among them, so an NMPA certificate confers none of the reliance or foreign-inspection exemptions tied to that list.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
pakistan
All classes (enlistment Class A, registration Class B-D)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2018-01-16
Source passage: ...enlisted or registered by the MDB or approved by any regulatory authority of USA, Japan, Australia, Canada, Austri[a]...
Prior approval / evidence record
Decreto Ejecutivo 490 of 4 October 2019 (Gaceta Oficial 28875-A), which regulates Ley 90/2017, requires in Art. 36 numeral 11 a valid Certificate of Free Sale issued by the competent authority of the country of provenance (all such countries if more than one), and defines the CLV as the document from the competent authority of the country of provenance showing the device is registered and legally authorized for sale there. An NMPA certificate is therefore the required document for devices sourced from China; the decree names no reference agencies and provides no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
panama
NMPA Class I filings and Class II/III certificates for all Panamanian device classes (registration under Ley 90/2017 and DE 490/2019)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2019-10-04
Source passage: 11. Certificado de Libre Venta vigente, emitido por la autoridad competente del país de procedencia. Si existe más de un país de procedencia deberán presentar el Certificado de Libre Venta de todos los países, se exceptúan de este requisito los productos fabricados en la República de Panamá.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
Yes
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
From 30-120 business days down to 15 business days
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For imported devices of every class, D.S. 016-2011-SA Arts. 124–127 numeral 2 require a copy of the free-sale certificate issued by the competent authority of the country of origin or of the exporter; an NMPA certificate therefore satisfies this requirement for China-made devices. Under Art. 21, a certificate issued by an authority that does not appear on DIGEMID's published list of competent authorities is valid only if legalized by the Peruvian consulate (or the exporting country's embassy in Peru) attesting that the issuer is the competent authority.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
peru
NMPA Class I filings and Class II/III certificates for DIGEMID device classes I, II, III and IV
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2011-07-27
Source passage: 2. Copia del certificado de libre comercialización emitido por la Autoridad competente del país de origen o exportador, para productos importados. ... (Art. 21) Se tiene por válido el certificado ... emitido por la autoridad competente del país de origen o exportador distinta a la que figura en dicho listado, siempre que cuente con la legalización del consulado peruano del lugar ... que acredite que es la Autoridad Competente.
Regulatory reference
D.S. 016-2011-SA Art. 9 fixes the closed list of 'países de alta vigilancia sanitaria' used throughout the regulation (for example acceptance of foreign GMP certificates in Arts. 22–23 and information sources for safety actions in Art. 13): France, Netherlands, United Kingdom, United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden. China is not on the list, so NMPA approvals or GMP certificates carry no high-vigilance status before DIGEMID.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
peru
NMPA Class II/III certificates; target DIGEMID device classes I–IV (references to 'países de alta vigilancia sanitaria' for GMP acceptance and product-evidence purposes)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2011-07-27
Source passage: Artículo 9°.- Países de alta vigilancia sanitaria. Para efectos de lo señalado en la Ley y el presente Reglamento, se consideran como países de alta vigilancia sanitaria los siguientes: Francia, Holanda, Reino Unido, Estados Unidos de América, Canadá, Japón, Suiza, Alemania, España, Australia, Dinamarca, Italia, Noruega, Bélgica y Suecia.
Prior approval / evidence record
For Class A notification of imported devices, the 2025 Citizen's Charter checklist requires evidence attesting to safety and effectiveness issued in the country of origin, which may be a product notification, certificate of product registration or equivalent document issued by the manufacturer (self-declaration), the regulatory agency or an accredited notified body. An NMPA Class I filing record or a Class II/III registration certificate for a China-made device satisfies this documentary requirement; there is no abridged review linked to it.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
philippines
Class A imported devices (Certificate of Medical Device Notification); NMPA Class I filing or Class II/III certificate serves as country-of-origin evidence
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2025-09-01
Source passage: Evidence attesting to safety and effectiveness issued in the country of origin: product notification, certificate of product registration, or equivalent document issued by the manufacturer (self-declaration), regulatory agency or accredited notified body
Regulatory reference
FDA Circular No. 2022-008 limits abridged processing to Class B/C/D devices with product approval issued by the national regulatory authority of an ASEAN member country under the AMDD-CSDT requirements, and expressly excludes devices whose CPR is based on abridged approval in countries outside ASEAN. China is not an ASEAN member, so an NMPA registration certificate does not qualify a device for abridged processing; such applications undergo standard CDRRHR technical review under AO 2018-0002.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
philippines
Class B/C/D medical devices (abridged processing); NMPA approvals not eligible; IVDs and refurbished devices excluded from the circular altogether
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: This Circular shall apply to Class B, C and D medical devices that are covered under AO No. 2018-0002, with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements ... This issuance shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN. ... Reference national regulatory authority (NRA) refers to the FDA counterpart regulatory authority of any ASEAN member country which approves medical devices based on the AMDD-CSDT requirements.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
poland
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
portugal
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For implantable medical device registration, MoPH's application checklist requires notarized CE or FDA certificates covering the devices; it enumerates only CE and FDA and offers no 'other reference authority' option. A China NMPA registration certificate is therefore not an accepted conformity credential for IMD registration in Qatar.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
qatar
Implantable medical devices (IMD) of any NMPA class; MoPH IMD registration is the only product-registration route Qatar operates for devices
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: 6. Notarized CE or FDA certificates from the country of origin with reference numbers of the devices for registration.
Prior approval / evidence record
The IMD registration checklist separately requires a Free Sale Certificate for the device from the country of origin. For a China-made implant this would be NMPA-based free-sale evidence, but it is a supplementary document that does not replace the CE/FDA certificate requirement or trigger any abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
qatar
Implantable medical devices (any NMPA class)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Source passage: 7. Free Sale Certificate (FSC) for the device from the country of origin.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
romania
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
National registration is conducted on the basis of technical tests, toxicological studies and clinical trials carried out as Russian conformity-assessment forms, production inspection, analysis of the manufacturer's evidence materials and Roszdravnadzor's expertise of quality, effectiveness and safety. The Rules recognise no foreign approval and the dossier list contains no country-of-origin registration certificate item, so a China NMPA certificate has no legal effect in the national procedure.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
russia
All classes under the national registration route (Government Decree No. 1684)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-03-01
Source passage: Государственная регистрация медицинских изделий проводится на основании результатов технических испытаний, токсикологических исследований, клинических испытаний, представляющих собой формы оценки соответствия медицинских изделий с учетом классификации в зависимости от потенциального риска их применения, инспектирования производства, анализа доказательных материалов производителя (изготовителя) медицинского изделия, экспертизы качества, эффективности и безопасности медицинских изделий...
Prior approval / evidence record
Roszdravnadzor, the Russian Ministry of Health and the Ministry of Industry and Trade are parties with China's NMPA to the BRICS regulators' Memorandum of Understanding listed by CDSCO as valid until 31 January 2029. It is a cooperation MoU and gives NMPA registrations no legal effect in Russia; no Russia-China mutual-recognition arrangement for medical devices exists.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
russia
Not class-specific; cooperation instruments only
Cooperation Mou
none
Product Marketing
Yes
Yes
Source passage: The Ministry of Health of The Russian Federation, The Ministry of Industry and Trade of The Russian Federation, The Federal Service for Surveillance in Healthcare (Russian Federation) ... The National Medical Products Administration of The People's Republic of CHINA (NMPA) ... 31.01.2029
Prior approval / evidence record
In the EAEU registration dossier filed with Roszdravnadzor, a copy of the registration certificate, free-sale certificate or export certificate issued in the manufacturer's country is an 'if available' item, together with information on registration in other countries. A China NMPA certificate is submitted under this item and does not abridge the EAEU expertise.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
russia
All classes under the EAEU common registration route (Council Decision No. 46)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2016-02-12
Source passage: 10. Копия регистрационного удостоверения медицинского изделия (сертификата свободной продажи, сертификата на экспорт (за исключением медицинских изделий, впервые произведенных на территории государства-члена)), выданного в стране производителя (при наличии)
Prior approval / evidence record
China NMPA registration certificate
No
Not a reliance trigger: NMPA is named nowhere in the Rwandan framework and is not a WHO Listed Authority, so an NMPA certificate serves as global market-history evidence rather than as the basis of an abridged assessment.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
SFDA and China's NMPA signed a Memorandum of Understanding on regulatory cooperation in medicines, medical devices and cosmetics at NMPA headquarters in Beijing on 1 November 2024 (SFDA CEO Hisham Aljadhey and NMPA Commissioner Li Li). SFDA describes its scope as exchange of regulatory information on laws and regulations and sharing of regulatory experience and best practices; the Saudi Council of Ministers approved the MoU on 12 May 2025. No implementing measure giving NMPA certificates any reliance or recognition effect in the MDMA process has been published by SFDA as of the check date, so the MoU is a cooperation framework, not a recognition route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
saudi-arabia
Not class-specific; regulator-to-regulator cooperation covering drugs, medical devices and cosmetics
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2024-11-01
Source passage: وقّعت الهيئة العامة للغذاء والدواء مذكرة تفاهم لتبادل الخبرات والمعلومات التنظيمية مع الإدارة الوطنية للمنتجات الطبية (NMPA) في جمهورية الصين الشعبية، وذلك في مقر الأخيرة بالعاصمة بكين. || Areas of cooperation outlined in the MoU regarding medicines, medical devices, and cosmetics include exchanging regulatory information pertaining to laws and regulations, as well as sharing regulatory experiences and best practices.
Regulatory reference
Under the Medical Devices Law (Royal Decree M/54) framework, the SFDA Medical Devices Marketing Authorization (MDMA) is a standalone technical-file assessment: MDS-REQ 1 v6.0 requires conformity with the Essential Principles (Annexes 1-2), technical documentation (Annexes 3-4) and an ISO 13485:2016 QMS, and neither lists reference regulators nor accepts any foreign marketing approval as a basis for authorization. The GHTF-founding-member basis (Australia, Canada, Japan, USA, EU/EFTA) of the pre-2021 Interim Regulation guidance MDS-G5 no longer appears in the current requirement. A China NMPA registration certificate therefore confers no abridged, verification or recognition route, and China was never a listed reference jurisdiction.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
saudi-arabia
All NMPA classes (Class I filing, Class II, Class III); SFDA MDMA covers Saudi Classes A-D and IVDs
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2021-12-19
Source passage: Medical device may be made available in return for payment or free of charge, with a view to distribution and/or use within the KSA only if it is registered at SFDA and obtaining medical devices marketing authorization (MDMA). 1 General Medical device shall comply with the "Essential Principles of Safety and Performance" specified in Annex (1) and Annex (2). 2 Medical device manufacture shall: - Prepare, hold and update the "Medical Device Technical Documentation" and/or "IVD Technical Documentation" that confirm to "Essential Principles of Safety and Performance" specified in Annex (3) and Annex (4) - Establish, document and maintain an effective quality management system (QMS) according to the international ISO standard (ISO 13485:2016) or any identical adopted standard for the same issue/version.
Regulatory reference
Registration with ALIMS under the Pravilnik o registraciji medicinskog sredstva (Sl. glasnik RS 84/2018, 58/2021, 6/2023) requires a Declaration of Conformity and, for all devices other than Class I and 'other' IVDs, an EC Certificate issued by a notified body; for Class I/other-IVD manufacturers from states that are not EU members and have no MRA/PECA with the EU, an accredited ISO 13485 certificate or proof that the device is marketed in an EU/MRA state is required. The bylaw's recognition procedure (Član 3-5) tests whether the foreign technical regulation and conformity-assessment body give at least the same protection as the Serbian technical regulation; it names no countries and provides no role for an NMPA registration certificate, so Chinese devices are registered on the basis of CE documentation.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
serbia
NMPA Class II/III certificates and Class I filings; target all Serbian classes (I, IIa, IIb, III, IVD)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2023-01-27
Source passage: 2) Сертификат о усаглашености медицинског средства (ЕC Certificate, односно сертификат који издаје именовано тело), осим за медицинска средства класе I и за остала in vitro дијагностичка медицинска средства [...] 3) ако је произвођач медицинских средстава класе I и остала in vitro дијагностичка медицинска средства [...] из државе која није држава чланица ЕУ, односно која није закључила Споразум о међусобном признавању са EУ (Mutual Recognition Agreements – MRAs) [...] сертификат система управљања квалитетом према ISO 13485 [...] односно доказ да се медицинско средство налази у промету у некој од држава чланица ЕУ, односно држава које су закључиле наведене споразуме
Prior approval / evidence record
HSA and NMPA signed a renewed and expanded MoU in Beijing on 11 May 2026, replacing the 2021 agreement, to strengthen regulatory cooperation and 'explore building facilitative regulatory pathways, pilot innovative schemes, capacity building and staff exchanges'. The MoU does not itself create any reliance route or recognition of NMPA device approvals; HSA's reference-agency list is unchanged.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
singapore
Framework MoU covering chemical drugs, APIs, biologics, TCM, medical devices, cosmetics and (new) cell, tissue and gene therapy products
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2026-05-11
Source passage: The renewed MOU expands the scope of regulatory cooperation into new emerging areas such as cell, tissue and gene therapy products, and strengthens collaboration to explore building facilitative regulatory pathways, pilot innovative schemes, capacity building and staff exchanges.
Regulatory reference
HSA's abridged, expedited (ECR/EDR) and immediate (IBR) evaluation routes are available only for devices with prior approval from HSA's overseas reference regulatory agencies, which are exhaustively listed as Australia TGA, EU Notified Bodies, Health Canada, Japan MHLW and US FDA. China's NMPA is not a reference agency, so an NMPA-registered device without one of those approvals undergoes full evaluation (optionally under the Priority Review Scheme).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
singapore
Class B/C/D devices and IVDs (abridged, expedited and immediate routes); NMPA Class II/III approvals do not qualify
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-03-13
Source passage: A medical device without prior approval from any of our overseas reference regulatory agencies must undergo a full evaluation. ... Overseas reference regulatory agencies: Australia Therapeutic Goods Administration (TGA); European Union Notified Bodies (EU NB); Health Canada (HC); Japan Ministry of Health, Labour and Welfare (MHLW); US Food and Drug Administration (US FDA)
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
slovakia
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
slovenia
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
SAHPRA recognises six jurisdictions for premarket evidence: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification. Establishment-licence applications must annex 'Evidence of premarket registration from one of the 6 jurisdictions recognised by SAHPRA', and Certificate of Free Sale applications for Class C and D devices must show pre-market approval/registration or emergency-use authorisation from at least one of the six or WHO PQ. China NMPA is not one of the six, so an NMPA-only Chinese device cannot satisfy the Class C/D evidence requirement.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-africa
NMPA Class II/III certificates; target South Africa Class C and D devices and IVDs (licence listing and Certificate of Free Sale)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-05-21
Source passage: For medium to high risk (Class C) and high risk (Class D) medical devices listed in the Certificate of Free Sale application: o Evidence of pre-market approval/registration/evidence of emergency use authorisation for each listed medical device/s from at least one of the six jurisdictions recognised by SAHPRA (Australia, Brazil, Health Canada, Europe, Japan, USFDA) or pre-qualification by the World Health [Organization] o Evidence of ISO13485 certification of the original manufacturer
Regulatory reference
SAHPRA's Medical Devices Reliance Guideline (SAHPGL-MD-22 v1, 25 February 2026; consulted as the November 2025 consultation text SAHPGL-MD-19_v1) grants abridged review only to devices already approved by a Recognised Regulatory Authority with which SAHPRA aligns (list to be published on SAHPRA's agreements/MoUs page), by a WHO Listed Authority (WHO permanent WLA list), under WHO CRP/PQ/EUL, or under the AMA continental procedure; a device without prior approval from any listed recognised authority goes to the full evaluation route. China NMPA is neither on the WHO WLA list nor named as an RRA, and SAHPRA's agreements page currently lists no China arrangement.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-africa
NMPA Class II/III certificates; target Class B, C and D product registration and licence listing (reliance pathways)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-02-25
Source passage: A medical device that has not obtained any prior approval from any of the listed medical device recognised regulatory authorities at the point of application will be subject to the full evaluation route. [...] i) RECOGNISED REGULATORY AUTHORITIES An application must have been approved by one or more of the RRAs with which SAHPRA aligns itself. The list of RRA is available on the SAHPRA website. [...] iv) WHO Listed Authority (WLA) https://www.who.int/publications/m/item/list-of-who-listed-authorities-wlas
Regulatory reference
Korea grants manufacturing/import approval only after MFDS (Class 3-4) or an MFDS-designated technical document review body (Class 2) reviews the application and technical documents for safety and performance under Medical Devices Act Arts. 6 and 15 and the MFDS Notice on Approval, Notification and Review of Medical Devices. No provision recognises a foreign marketing approval as a basis for abridged or waived review; foreign data are accepted only as content of the technical file (e.g., clinical data), and MDSAP results are used only within the KGMP audit layer (already held).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-korea
All device classes (1-4) and IVDs; NMPA Class I-III certificates confer no review benefit
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: ｢의료기기법｣ 제6조제2항 및 같은 법 시행규칙 제5조제1항, ｢의료기기 허가・심사・신고 등에 관한 규정｣에 따라 신청사항 및 제출 자료를 심사하여 안전성과 성능이 적합한 경우 의료기기를 허가 ... 등급별로 심사기관이 다르며, 2등급은 식약처장으로부터 지정받은 기술문서심사기관이, 3·4등급은 식약처에서 심사
Prior approval / evidence record
NMPA and MFDS signed a Memorandum of Understanding on regulatory cooperation for drugs, medical devices and cosmetics in Beijing on 26 February 2019. The MoU sets cooperation areas and channels (high-level meetings, staff visits and training, information exchange) and does not establish any reliance, mutual recognition or abridged review of each other's device approvals. No subsequent Korea-China device reliance pilot has been announced by either regulator as of the check date.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-korea
Framework MoU covering drugs, medical devices and cosmetics; no product-class scope
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2019-02-26
Source passage: 《合作谅解备忘录》明确了双方未来的合作领域和方向，同意通过高层会晤、人员互访和培训、信息交流等方式进一步加强双方在药品、医疗器械和化妆品监管领域的合作。
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
spain
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
NMRA's reliance pathway considers registrations only from the USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member states (plus Singapore for IVDs). China/NMPA is not a recognized reliance country, so a China NMPA certificate does not open the reliance pathway and the device follows the standard consolidated-dossier evaluation.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
sri-lanka
All device classes (general medical devices and IVDs)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2025-07-23
Source passage: Reliance Pathway - Recognized Countries: For General Medical Devices, registration from the following countries will be considered under the reliance pathway: USA, UK, Australia, Canada, Japan, Norway, Switzerland & All European Union (EU) member countries. For In Vitro Diagnostic (IVD) Medical Devices: USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
sweden
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Regulatory reference
Switzerland recognises only the EU CE conformity route (unilateral recognition of CE-marked devices under the MedDO/IvDO); a China NMPA registration certificate gives no route to the Swiss market and is not assessed. A Chinese manufacturer needs CE conformity assessment plus a Swiss authorised representative and Swissmedic registration duties.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
switzerland
All NMPA classes -> all Swiss classes
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: Switzerland unilaterally recognises the CE label for medical devices (existing verified source section).
Regulatory reference
Taiwan does not recognise NMPA approval and additionally restricts PRC-origin devices: 附表二 說明十三(三) provides that a device manufactured in China may only be submitted for TFDA registration after the applicant first obtains permission-to-import documentation from the Ministry of Economic Affairs (formerly Bureau of Foreign Trade, now International Trade Administration), reflecting the Mainland-goods import controls under the restricted-import list. Only tariff lines published as permitted Mainland goods may be imported freely; other items require a project-based (專案) approval from the trade authority before TFDA will accept the registration application.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
taiwan
All imported devices whose place of manufacture is Mainland China (陸製醫療器材), all classes; NMPA registration confers no import right
Import Restriction
none
Filing Prerequisite
Yes
Yes
Effective from 2023-11-27
Source passage: (三) 為配合經濟部國際貿易局公告之限制輸入貨品及海關協助查核輸入貨品彙總表，輸入產地為中國之醫療器材，應先向經濟部國際貿易局取得准許輸入之證明文件，始得向中央主管機關申請查驗登記。
Prior approval / evidence record
TFDA import registration for Class II/III devices requires an original 出產國許可製售證明 (certificate that the device is approved for manufacture and free sale) issued by the highest health authority of the country of manufacture, stating device name/model, manufacturer name/address and approval-for-sale status. For a device made in Mainland China the NMPA registration certificate or an NMPA-issued free-sale/export certificate is the document that meets this definition; it is a dossier element only and TFDA performs full technical review. The certificate must be issued within 2 years and authenticated by a Taiwan overseas mission unless issued by a country with a device pre-market technical cooperation agreement with Taiwan.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
taiwan
Imported Class II/III devices (Class I import registration also requires FSC per 附表一); NMPA Class II/III certificate serves as the country-of-manufacture free-sale evidence for PRC-made devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2023-11-27
Source passage: 四、出產國許可製售證明：(一) 本項文件應記載下列事項：1、醫療器材之名稱、規格型號。2、製造業者名稱、地址、製造情形及核准在其本國販賣實況。... (三) 本項文件限出具日起二年內有效，且應經我國駐該地區之駐外使領館、代表處、辦事處或外交部授權之駐外機構驗證。
Regulatory reference
TMDA's device registration framework (Control of Medical Devices Regulations 2015 and the June 2024 Compendium) subjects all Class A-D devices and IVDs to independent dossier assessment with no reference-authority list and no abridged pathway based on foreign approvals; TMDA's separate regulatory-reliance guideline (17 April 2025) covers marketing authorisation of human medicinal products only, and the only device-related reliance mechanism is the WHO Collaborative Registration Procedure for WHO-prequalified IVDs. An NMPA registration therefore gives no procedural benefit beyond documentary marketing-history evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
tanzania
all device classes A (registrable), B, C, D and IVDs under standard registration
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-01
Source passage: According to The Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015, all class A, B, C and D devices get market approval through registration while a selected class A devices attain market approval through notification. [...] For requirements for registration, please refer to Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020
Prior approval / evidence record
TMDA's Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment (TMDA/DMD/MDA/G/001 Rev 03, June 2024) requires applicants for specialised devices such as MRI, ultrasound, X-ray and ECHO systems to submit a 'Certificate of market approval from any other country and market history', listing all countries where the device is marketed or withdrawn. An NMPA registration certificate satisfies this documentary requirement for a China-made device; the compendium names no reference regulatory authorities and provides no abridged route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
tanzania
NMPA Class II/III certificates as foreign market-approval evidence; target Tanzania Class B, C and D specialised devices (MRI, ultrasound, X-ray, ECHO and similar)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2024-06-01
Source passage: a) Certificate of market approval from any other country and market history. Brief description of the foreign marketing history, if any, of the device, including a list of all countries in which the device has been marketed and a list of all countries in which the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device.
Regulatory reference
Thai FDA offers two submission channels: the full pathway and the abridged evaluation pathway, the latter reserved for devices with a registration history from the agencies Thai FDA recognises: Australia TGA, Health Canada, EU Notified Bodies, Japan MHLW, US FDA and WHO Prequalification for IVDs. China's NMPA is not a recognised reference agency, so NMPA-registered devices are evaluated under the full pathway. The Singapore HSA reliance programme and the Malaysia MDA reliance programme (both held) are the only bilateral reliance channels and do not involve China.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
thailand
Class 2-4 devices and IVDs (detailed notification and licence routes); NMPA approvals do not qualify for the abridged pathway
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-04
Source passage: 2. การประเมินเอกสารแบบย่อ (Abridged pathway) สำหรับเครื่องมือแพทย์ที่มีประวัติการขึ้นทะเบียนจากหน่วยงานที่ อย. รับรอง ดังนี้ Therapeutic Goods Administration: TGA; Health Canada: HC; European Union Notified Bodies: EU NB; Japan Ministry of Health Labour and Welfare: MHLW; US Food and Drug Administration: US FDA; WHO Prequalification of in Vitro Diagnostics (IVD)
Regulatory reference
Türkiye's Tıbbi Cihaz Yönetmeliği (national transposition of EU MDR 2017/745) allows a device to be placed on the Turkish market only if it meets the Regulation's requirements, demonstrated through the conformity-assessment procedures of Annexes IX-XI (notified-body involvement for Class IIa and above) and evidenced by CE marking. The Regulation contains no clause recognising, abridging on the basis of, or otherwise giving effect to a non-EU marketing authorisation; a China NMPA registration certificate or Class I filing has no regulatory status in Türkiye, and a Chinese manufacturer must obtain CE certification under the aligned regulation and register in ÜTS/EUDAMED through a Turkish authorised representative/importer.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
turkey
All NMPA classes (Class I filing, Class II/III registration) mapped to Türkiye Class I/IIa/IIb/III; IVDs under the parallel IVD regulation
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2021-06-02
Source passage: MADDE 5- (1) Usulüne uygun olarak temin edildiğinde ve doğru şekilde kurulduğunda, bakımı yapıldığında ve kullanım amacına uygun şekilde kullanıldığında bu Yönetmeliğin gerekliliklerini karşılayan cihazlar, piyasaya arz edilebilir veya hizmete sunulabilir. [...] MADDE 20 - (1) Ismarlama imal edilen veya araştırma amaçlı cihazlar hariç olmak üzere, bu Yönetmeliğin gerekliliklerine uygun olduğu kabul edilen cihazlar, Ek V'te gösterildiği şekilde CE uygunluk işareti taşır. [...] MADDE 52 – (1) İmalatçılar, bir cihazı piyasaya arz etmeden önce, Ek IX ila Ek XI'de belirtilen ilgili uygunluk değerlendirme prosedürleri uyarınca söz konusu cihazın uygunluğunun değerlendirmesini gerçekleştirir.
Prior approval / evidence record
Article 6(1)(c) provides for EDE assessment of reference-country marketing approvals or research information demonstrating effectiveness, safety and quality. It does not name NMPA, automatically accept an NMPA certificate or Class I filing record, or create an NMPA-specific abridged route. Any Chinese origin-country evidence must meet the applicable EDE documentary requirements and remains subject to EDE assessment.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uae
No NMPA class or filing record is expressly accepted by the cited provision; product-specific EDE requirements must be met.
Eligibility Unresolved
undetermined
Product Marketing
Yes
Yes
Effective from 2025-01-02
Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.
Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
Yes
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
China NMPA registration certificate
No
China is not on NDA's recognised-country list, which is closed: DAR/GDL/028 §4.11 enumerates the United States, Canada, Japan and Europe, Table 2 names Australia, Canada, the European Union, Japan and the United States, and the medical-devices page names the same five. An NMPA registration therefore does not put a product into Track 1 and does not satisfy the §4.11 gate for classes B-D; a Chinese-manufactured device reaches Uganda through Track 2 or Track 3, and the country-of-origin marketing approval must still be legalised and filed in every case.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.
WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.
Prior approval / evidence record
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Uganda's recognised-country list is closed and does not include China. DAR/GDL/028 s. 4.11 enumerates the recognised countries as the United States, Canada, Japan and Europe; Table 2 names Australia, Canada, the European Union, Japan and the United States; and NDA's Medical Devices page names 'Australia, Canada, European Union countries, Japan, and the United States'. A China NMPA registration therefore does not by itself put a product into Track 1 and does not satisfy the s. 4.11 certification gate for classes B-D. The applicable track depends on the device's qualifying approvals and evidence, not its manufacturing country alone. A Chinese-manufactured device holding a qualifying recognised-country approval may use Track 1. The separate country-of-origin approval document requirement remains applicable.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2020-08-14
Upgraded from source-backed-partial: round 204 recorded this negative from the same lists but could not read the document directly. The lists are closed enumerations ('the recognized countries below', 'the IMDRF founding member countries') and the excerpt quotes them, which is what makes the bounded negative verifiable. This entry deliberately does not repeat round 204's earlier framing, which described the s. 4.11 gate in terms of 'China NMPA' rather than the closed list; the value here is bounded to the list itself. NDA's page list omits Australia's GMPALS detail and the guideline's Table 2 omits nothing, so the three citations are consistent.
Regulatory reference
Great Britain requires UKCA marking (or, within the statutory transition, CE marking) under the UK MDR 2002 before a device is placed on the market; MHRA guidance names no third-country approval other than CE, so a China NMPA registration certificate is not recognised and creates no abridged route. Overseas manufacturers also need a UK Responsible Person and MHRA registration.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uk
All NMPA classes -> all UK classes
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: Existing verified sections: CE-marked devices accepted in Great Britain until 30 June 2028/2030; UKCA route; no other foreign approval named.
Regulatory reference
Ukraine requires conformity assessment to its technical regulations by Ukrainian designated bodies and recognises no foreign registration certificate. The martial-law derogation (Resolution 389 of 29 March 2022) only lets a Ukrainian designated body recognise results of conformity assessment performed by foreign accredited conformity-assessment bodies under Article 45(1) and (3) of Law 124-VIII, which requires an accreditation-body MLA link and a recognition agreement between the Ukrainian designated body and the foreign body. An NMPA registration certificate is a regulator's approval, not an accredited-body assessment result, and no arrangement with Chinese bodies is provided for or was found.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ukraine
All classes (Technical Regulations 753, 754, 755)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2022-03-30
Source passage: 2-6. Установити, що на період воєнного стану введення в обіг та/або експлуатацію медичних виробів/систем медичних виробів/процедурних наборів, щодо яких не виконані вимоги Технічного регламенту, затвердженого цією постановою, дозволяється за умови визнання призначеним органом з оцінки відповідності результатів оцінки відповідності, проведеної іноземними акредитованими органами з оцінки відповідності, відповідно до вимог частин першої та третьої статті 45 Закону України «Про технічні регламенти та оцінку відповідності».
Prior approval / evidence record
Decreto 3/008 Art. 7 d) requires, for product registration before the Ministry of Public Health, a free-sale certificate issued by the competent body of the country of origin; if the origin authorities do not issue one and MSP deems it pertinent, it may be replaced by a quality certificate from recognized bodies. An NMPA registration/free-sale certificate is therefore the required origin document for China-made devices. The decree contains no reference-country list and no abridged review based on foreign approvals, and MSP evaluates safety and efficacy under Art. 8 f) with the option to require clinical investigation.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uruguay
NMPA Class I filings and Class II/III certificates for all MSP product categories (reactivos de diagnóstico, equipos médicos, dispositivos médicos)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2008-01-17
Source passage: d) certificado de libre venta emitido por el organismo competente del país de origen. En caso de que las autoridades del país de origen no lo emitieran y si el Ministerio de Salud Pública lo juzga pertinente, podrá sustituirse por certificado de calidad otorgado por organismos reconocidos;
Regulatory reference
FDA requires foreign manufacturers to meet applicable US requirements, including establishment registration, device listing, quality-system, labelling and reporting requirements, a US agent, and premarket notification or approval unless exempt. An NMPA certificate alone does not discharge these obligations. Determine the FDA class and submission/exemption separately.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
usa
All NMPA classes -> all FDA classes
No Reliance Route
none
Product Marketing
null
null
Independent primary-page review 2026-09-15. The earlier purported quote about recognising no foreign authorisations was not on the cited page and has been removed.
Prior approval / evidence record
On 27 June 2025 NMPA Commissioner Li Li and Alisher Temirov, Director of the Pharmaceutical Safety Center of the Uzbekistan Ministry of Health, signed in Beijing the 'Memorandum of Understanding between the NMPA of the PRC and the Pharmaceutical Safety Center of the Ministry of Health of the Republic of Uzbekistan on regulatory cooperation for drugs and medical devices'. The MoU establishes cooperation and exchange; it does not add NMPA to Uzbekistan's recognition list.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uzbekistan
Not class-specific; regulatory-cooperation MoU (drugs and medical devices)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2025-06-27
Source passage: 6月27日，国家药监局局长李利在京会见乌兹别克斯坦卫生部药品安全中心主任阿利舍尔•特米罗夫一行，双方就进一步加强中乌在药品监管领域的交流合作进行了深入务实交流，并签署《中华人民共和国国家药品监督管理局与乌兹别克斯坦共和国卫生部药品安全中心关于药品和医疗器械监管合作谅解备忘录》。
Prior approval / evidence record
The general-route dossier table requires, for every class, a certificate of registration of the device in the manufacturer's country or a document confirming registration (free-sale certificate, export certificate with state-language translation), or a copy of a document confirming registration in other countries. A China NMPA registration certificate or NMPA-based export certificate satisfies this item; the device still undergoes full expertise (60-120 working days by class).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uzbekistan
All classes (I, IIa, IIb, III) under the general registration route
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2026-02-26
Source passage: 5. Тиббий жиҳознинг ишлаб чиқарувчи давлатида рўйхатдан ўтказилганлик ҳақида гувоҳнома ёки рўйхатдан ўтказилганлигини тасдиқловчи ҳужжат (эркин реализация учун сертификат, экспорт сертификати (давлат тилига таржимаси билан) ёки бошқа давлатларда рўйхатдан ўтганлигини тасдиқловчи ҳужжатнинг нусхаси. + + + +
Regulatory reference
Under Cabinet of Ministers Resolution No. 738, medical devices are registered by the recognition route only if registered by the US FDA, EU bodies authorised to issue CE certificates, the EMA, Japan's PMDA, Korea's MFDS or the UK MHRA. China's NMPA is not on the list, so a China NMPA certificate does not open the 15-working-day recognition route and the device follows the general (full) registration procedure.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uzbekistan
All classes (recognition route)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-02-26
Source passage: Бунда қуйидаги хорижий ташкилотлар томонидан рўйхатдан ўтказилган тиббий жиҳозлар тан олиш йўли билан давлат рўйхатидан ўтказилади: Озиқ-овқат ва дори воситалари сифати назорати бошқармаси (FDA), АҚШ; Европа мувофиқлиги (СЕ) сертификатини беришга ваколатли органлар, Европа Иттифоқи; Европа дори воситалари агентлиги (EMA), Европа Иттифоқи; Фармацевтика ва тиббий буюмлар агентлиги (PMDA), Япония; Озиқ-овқат ва дори воситалари хавфсизлиги вазирлиги (MFDS), Корея Республикаси; Дори воситалари ва тиббий буюмлар назорати агентлиги (MHRA), Буюк Британия.
Prior approval / evidence record
Decree 98/2021/NĐ-CP (consolidated text 08/VBHN-BYT of 6 March 2026) names China's NMPA as one of the 'reference countries' (nước tham chiếu): a Class C/D device holding a Certificate of Free Sale or Market Authorization from a reference country qualifies for fast-track issuance of a circulation number under Art. 29(2)(a). The fast-track dossier (Art. 30(3)) consists of the application, legal documents, the reference-country marketing document, a Vietnamese IVD quality certificate where applicable, and the CSDT; the Ministry of Health assesses only the legal documents and must issue the circulation number within 10 working days of a complete dossier (Art. 32(3)(a)). Other reference countries are US FDA, Australia TGA, Health Canada, Japan MHLW/PMDA, EU member states, UK, Switzerland and Korea MFDS.
china
nmpa
Valid Certificate of Free Sale or Market Authorization from China NMPA, as the named reference authority
vietnam
Products holding the qualifying reference-authority document and independently classified as Vietnam Class C or D; do not assume Chinese risk classes map to Vietnam
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2022-01-01
Source passage: 2. Cấp nhanh số lưu hành mới đối với thiết bị y tế thuộc một trong các trường hợp sau đây: a) Đã được một trong các tổ chức hoặc nước sau cấp giấy chứng nhận lưu hành tự do (Certificate of Free Sale) hoặc giấy chứng nhận lưu hành (Market Authorization) (sau đây viết tắt là giấy lưu hành): Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ (FDA) - Mỹ; Cục Quản lý hàng hóa trị liệu (TGA) - Úc; Cơ quan quản lý y tế Canada (Health Canada); Bộ Y tế, Lao động và Phúc lợi Nhật Bản (MHLW) hoặc Cơ quan Dược phẩm và Thiết bị y tế (PMDA) - Nhật Bản, các nước thành viên EU, Anh, Thụy Sỹ; Cục Quản lý sản phẩm y tế quốc gia cấp trung ương (National Medical Products Administration - NMPA) - Trung Quốc; Bộ An toàn thực phẩm và dược phẩm (Ministry of Food & Drug Safety - MFDS) - Hàn Quốc hoặc thuộc danh sách các tổ chức cấp giấy lưu hành được cơ quan có thẩm quyền của Việt Nam công nhận (sau đây viết tắt là nước tham chiếu);
Prior approval / evidence record
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
China NMPA medical device registration certificate or Class I filing record
No
No route. The NMPA is not among the approvals the Annex I form asks the applicant to disclose, and no recognition procedure in the non-IVD or IVD guideline names it. An NMPA certificate may be filed as documentary proof of registration in other countries, which carries no procedural benefit, and it cannot substitute for the Free Sale Certificate, which must be addressed to Zambia from the manufacturer's own authority.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Origin Country Evidence
Evidence Only
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non-IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non-IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance.
Product Marketing
Yes
Yes
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An FDA, CE, PMDA, MFDS or NMPA approval holder has nowhere to file it in Zimbabwe. Zimbabwe does not operate a general medical device registration pathway: the Medicines and Allied Substances Control Act's registration machinery covers medicines, and devices enter control only through ministerial regulations made under section 38(1)(b). The only device classes ever brought under control are male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). For any other device - an infusion pump, an orthopaedic implant, a CT scanner, an IVD - there is no marketing authorisation to apply for, so no foreign approval can open, shorten or substitute for one. MCAZ's own Strategic Plan 2026-2030 records the Medical Devices Unit's entire regulatory function as the assessment of male condoms and medical gloves, and lists an 'expanded scope to medical devices and allied substances' as an effect of a Medical Products and Allied Substances Control Bill that is still only proposed.
none
No Reliance Route
none
Product Marketing
No
Yes
The claim rests on the Act's long title and structure (Part IV, 'REGISTRATION OF MEDICINES', ss.26-41, is the only registration regime in the Act) read together with the exhaustive MCAZ listing of device instruments (only the Condom Regulations, the Glove Regulations and their 2014 amendments) and the Strategic Plan 2026-2030 statement that the Medical Devices Unit's functions are 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005', 'Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006' and 'Factory inspections (cGMP) of condom and glove manufacturing facilities'. No device registration guideline, application form or device fee schedule exists in MCAZ's published document set.
Prior approval / evidence record
China NMPA medical device registration certificate
No
No route, and the NMPA is not named in any Zimbabwean device instrument retrieved. An NMPA certificate carries no procedural benefit in Zimbabwe.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Foreign Clinical Data
Yes
May be accepted if China GCP compliant
12-18 months if accepted
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Hainan Boao Pilot Zone
Fast-track initial use with real-world data collection
4 months vs 3-5 years standard
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
NMPA Registration
5
6
months
official-verified
NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300201
2026-08-25
24
36
months
14
20
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For import Class II/III registration the designated China agent submits, together with the application dossier, the marketing-approval certificate issued by the regulator of the registrant's home country/region. The certificate functions as an eligibility/documentary gate, not a reliance route: NMPA still performs its own full review.
Prior approval / evidence record
Greater Bay Area (GBA) Connect
Fast-track for Hong Kong/Macau approved devices
Access to 9 major cities
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Required as home country approval
Required documentation
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
China's National Medical Products Administration (NMPA) is a member of the IMDRF Management Committee, listed by IMDRF alongside Australia TGA, Brazil ANVISA, Health Canada, the European Commission, Japan PMDA/MHLW, the Russian Ministry of Health, Singapore HSA, South Korea MFDS, Swissmedic, UK MHRA and US FDA; China is scheduled to hold the IMDRF chair in 2030. Membership does not itself grant product market access; each destination rule must independently establish its legal effect.
china
nmpa
IMDRF Management Committee membership (not product approval)
china
NMPA as an authority (all device and IVD classes)
International Listing
Evidence Only
Authority Status
null
null
Source passage: The current members are: Australia, Therapeutic Goods Administration; Brazil, ANVISA; Canada, Health Canada; China, National Medical Products Administration; European Union ...; Upcoming rotations are as follows: 2027 - Brazil, 2028 - Canada, 2029 - UK, 2030 - China
Regulatory reference
WHO's list of transitional WHO Listed Authorities for medical devices (tWLAs-MD), as of 1 July 2026, names China's National Medical Products Administration (NMPA) with the scope 'Medical devices including in vitro diagnostics', alongside TGA, ANVISA, Health Canada, the European Medical Devices Regulatory Network, MFDS, MHLW/PMDA, the Russian Ministry of Health, Swissmedic, HSA, MHRA and US FDA. The list exists to support regulatory reliance on medical devices and is built from the WHO Prequalification recognized regulatory authorities plus IMDRF Management Committee membership as of 30 June 2026; whether a given importing regulator relies on it is that regulator's decision.
china
nmpa
WHO transitional medical-device authority listing (not product approval)
china
NMPA as an authority (all device and IVD classes)
International Listing
Evidence Only
Authority Status
null
null
Effective from 2026-07-01
Source passage: 4. China National Medical Products Administration (NMPA) Medical devices including in vitro diagnostics ... 2. The list is built based on the existing list of Recognized Regulatory Authorities by the WHO Prequalification for medical devices and membership to Management Committee of the International Medical Devices Regulators Forum (IMDRF), as of 30 June 2026.
Prior approval / evidence record
Priority Review (Innovative Devices)
Expedited review for rare diseases, malignant tumors, pediatric devices
6-12 months faster
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Innovative medical devices not yet marketed outside China need not submit the home-country/region marketing-approval certificate in the import filing/registration.
Prior approval / evidence record
EU CE Mark
Yes
Required as home country approval
Required documentation
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Pilot Phase 1 (30 July - 30 September 2025) under the MDA-NMPA MoU: Chinese-made IVDs (Class II approved by Provincial MPA or Class III by NMPA, manufacturer owning its China facility) are eligible for Malaysia's verification pathway, and Malaysian-made IVDs (Class B, C or D approved by MDA) are eligible for China's green channel; up to 6 applications per side, priority for rare-disease and innovative devices.
Effective from 2025-07-30 · Effective until 2025-09-30
What review, validation, and applicant stop-clock rules apply?
For high-risk Class III clinical-trial approval applications, CMDE must decide whether to agree within 60 days of acceptance and notify the applicant via the CMDE website; if no notice is given within the period, the trial application is deemed agreed (silence = consent).
Where supplementary information is required during review, the applicant must deliver all requested items in a single submission within 1 year of receiving the notice; failure leads to termination of the technical review or rejection of the application.
Excerpt in English as published in the official NMPA translation.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Devices for rare diseases, life-threatening conditions without effective treatment, or public-health emergencies may receive conditional approval (附条件批准) with the conditions recorded in the registration certificate; for emergency use, NMPA may, after organized assessment and consent, permit use of devices within a defined scope and period.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Applicants who disagree with an approval conclusion on NMPA licensing items may seek administrative reconsideration (行政复议) by NMPA or file administrative litigation (行政诉讼).
Which UDI, device listing, database, and traceability duties apply?
NMPA operates the national UDI database; registrants/holders must upload the product identifier (UDI-DI) and related data to the database, per the UDI System Rules (NMPA Announcement No. 66 of 2019).
Following implementation across all Class III devices (incl. IVDs) and 103 Class II device types, all Class II devices (including IVDs) and all Class I IVDs produced from 2027-06-01, and all Class I devices produced from 2029-06-01, must carry a UDI.
Effective from 2027-06-01
UDI is implemented in batches: from 2021-01-01 the first 9 categories / 69 types of Class III devices; from 2022-06-01 all other Class III devices including IVDs; from 2024-06-01 the third batch covers selected Class II devices (high-volume single-use, centralized-procurement and medical-aesthetics products), devices in scope produced from that date must carry a UDI, and new registration applications must submit the UDI-DI of the smallest sales unit in the registration system.
Effective from 2021-01-01
What is reportable, by whom, where, in what format, and by what deadline?
Group (群体) adverse events must be reported within 12 hours by phone/fax to the provincial drug regulatory and health departments where the event occurred, with basic information entered in the national monitoring system and each individual case reported within 24 hours; the holder must immediately suspend production and sales, notify user units to stop use, investigate, run a QMS self-inspection, and report to both provincial authorities and monitoring institutions within 7 days.
Effective from 2019-01-01
Reporting follows the report-if-suspicious (可疑即报) principle: events that led or may lead to serious injury or death must be reported (innovative devices: all events in the first registration cycle). Individual deadlines: fatal events within 7 days; serious injury or possible serious injury/death within 20 days; events occurring overseas known to the holder within 30 days; evaluation results reported to the provincial monitoring centre within 30 days (death) or 45 days (serious).
Effective from 2019-01-01
china:medical-device
china
Risk classes I through III.
i
Class I
low
ii
Class II
medium
iii
Class III
highest
NMPA
official-source-verified
NMPA medical-device classification rules
https://english.nmpa.gov.cn/2019-10/11/c_415411.htm
2026-08-13
China
china
CN
🇨🇳
National Medical Products Administration
NMPA
asia-pacific
1
3-class (I, II, III)
class-i
Class I
low
Filing/Recordation (备案) — no review, no fee
0
0
days
official-verified
NMPA service item — 进口第一类医疗器械备案 (imported Class I device filing): 办件类型 即办件, filed 当场 once the materials are complete and in the required form, no fee, and Regulation No. 739 art. 15 obliges publication within 5 working days of receipt
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
2026-08-30
2
4
months
No
No
No
class-ii
Class II
medium
Provincial Registration
4
4
months
official-verified
NMPA licensing service item — promised acceptance 5 working days, statutory approval clock
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300301
2026-08-25
12
18
months
No
Yes
Yes
class-iii
Class III
highest
NMPA Registration
5
6
months
official-verified
NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300201
2026-08-25
24
36
months
14
20
months
Yes
Yes
Yes
Priority Review (Innovative Devices)
Expedited review for rare diseases, malignant tumors, pediatric devices
6-12 months faster
Hainan Boao Pilot Zone
Fast-track initial use with real-world data collection
4 months vs 3-5 years standard
Greater Bay Area (GBA) Connect
Fast-track for Hong Kong/Macau approved devices
Access to 9 major cities
FDA 510(k)/PMA
Yes
Required as home country approval
Required documentation
EU CE Mark
Yes
Required as home country approval
Required documentation
Foreign Clinical Data
Yes
May be accepted if China GCP compliant
12-18 months if accepted
Yes
China Agent
No
Not accepted
5 years (Class II & III), Unlimited (Class I)
2026-08-30
official-verified
医疗器械监督管理条例 (Regulations on the Supervision and Administration of Medical Devices, State Council Order No. 739). Art. 13 puts Class I on filing and Classes II and III on registration; art. 15 completes the filing on submission of conforming materials; art. 18 gives the registering authority 20 working days from receipt of the review opinion to decide
https://www.gov.cn/zhengce/zhengceku/2021-03/18/content_5593739.htm
2026-08-30
NMPA service item — 进口第一类医疗器械备案 (imported Class I device filing): 办件类型 即办件, filed 当场 once the materials are complete and in the required form, no fee, and Regulation No. 739 art. 15 obliges publication within 5 working days of receipt
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
2026-08-30
NMPA licensing service item — promised acceptance 5 working days, statutory approval clock
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300301
2026-08-25
NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300201
2026-08-25
2026-08-30
china
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Device Classification
Classify device under NMPA rules (Class I, II, or III). Class III requires full registration.
2-4 weeks
🏷️
2
In-Country Testing
Testing at NMPA-designated Chinese laboratories required for most Class II/III devices.
3-6 months
🧪
3
Clinical Trial (if required)
Many Class II/III devices require Chinese clinical trials. Can take 12-24 months.
12-24 months
🏥
4
Appoint Agent
Foreign manufacturers must appoint a Chinese agent/legal representative for submissions.
2-4 weeks
🏛️
5
NMPA Application
Submit registration dossier to NMPA/CFDA. Documentation must be in Chinese.
1-2 weeks
📤
6
NMPA Review
NMPA conducts technical review. Multiple Q&A rounds common. Average 12-18 months for Class III.
12-18 months
⚙️
7
Registration Certificate
NMPA issues registration certificate. Valid 5 years with annual renewal requirements.
2-4 weeks
✅
China
china
CN
NMPA
0
210900
CNY
Yes
308800
308800
CNY
Yes
imported-class-i-filing
Imported Class I filing
CNY
0
CNY 0
Per filing
The official service lists no government application charge.
exact-current
official-verified
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
NMPA imported Class I device filing service
2026-08-25
imported-class-ii-registration
Imported Class II registration
CNY
210900
CNY 210,900
Per registration
exact-current
official-verified
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300301
NMPA imported Class II device registration service
2026-08-25
imported-class-ii-change-registration
Imported Class II change registration (变更注册)
CNY
42000
CNY 42,000
Per registration
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
imported-class-ii-renewal-registration
Imported Class II renewal registration (延续注册)
CNY
40800
CNY 40,800
Per renewal
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
imported-class-iii-registration
Imported Class III registration
CNY
308800
CNY 308,800
Per registration
exact-current
official-verified
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300201
NMPA imported Class III device registration service
2026-08-25
imported-class-iii-change-registration
Imported Class III change registration (变更注册)
CNY
50400
CNY 50,400
Per registration
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
imported-class-iii-renewal-registration
Imported Class III renewal registration (延续注册)
CNY
40800
CNY 40,800
Per renewal
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
domestic-class-iii-first-registration
Domestic Class III first registration (境内第三类首次注册)
CNY
153600
CNY 153,600
Per registration
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
domestic-class-iii-change-registration
Domestic Class III change registration
CNY
50400
CNY 50,400
Per registration
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
domestic-class-iii-renewal-registration
Domestic Class III renewal registration (国产第三类延续注册)
CNY
40800
CNY 40,800
Per renewal
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
clinical-trial-application-high-risk
Clinical-trial application - high-risk medical device (domestic and import Class III)
CNY
43200
CNY 43,200
Per application
exact-current
official-verified
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
NMPA administrative-licensing fee catalogue for medical devices
2026-08-25
2026-08-25
official-verified
NMPA imported Class I device filing service
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
2026-08-25
NMPA imported Class II device registration service
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300301
2026-08-25
NMPA imported Class III device registration service
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017214300201
2026-08-25
NMPA administrative-licensing fee catalogue for medical devices
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
2026-08-25
2026-08-25
exact-current
Yes
china
China
low
nmpa-electrical-emc-evidence
NMPA electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
Devices must comply with mandatory national standards (GB), or where none exists mandatory industry standards (YY) (Regulations Art. 7). Registration testing may be performed by the registrant itself under the Registration Self-Testing Provisions (NMPA Announcement No. 126 of 2021) as an alternative to third-party testing.
candidate
srrc-radio-transmission-equipment-type-approval
SRRC radio transmission equipment type approval
Radio Spectrum
Mandatory If Feature
Catalogued Radio Transmitter
candidate
ccc
CCC
General Electrical Components
Mandatory If Feature
Catalogued Product Or Component
unresolved
samr-p-p-v-legal-metrology
SAMR P/P+V legal metrology
Legal Metrology
Mandatory If Feature
Catalogued Measuring Instrument
candidate
china-rohs
China RoHS
Environmental And Batteries
Mandatory If Feature
Electrical Electronic Product
unresolved
MIIT
radio transmission equipment type approval
https://www.miit.gov.cn/jgsj/wgj/bmgz/art/2023/art_c504af4beeb944fba57e618140959213.html
CNCA
compulsory product certification
https://www.cnca.gov.cn/hlwfw/ywzl/qzxcprz/index.html
SAMR
compulsorily managed measuring-instrument catalogue
https://www.samr.gov.cn/jls/zt/jlfwzxqy/zcfg/art/2023/art_1d7270734e844327aec3ff6738dbf9b0.html
NMPA
Regulations mandatory national and industry standards for devices
https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20250416172904188.html
NMPA
Registration Self-Testing Provisions Announcement 126 of 2021
https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20211022153823130.html
