Explore the medical device requirements currently available for Japan, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
No person may advertise, describe or disseminate false or exaggerated claims — explicit or implicit — about the name, manufacturing method, efficacy, effects or performance of devices.
Advertising the name, manufacturing method, efficacy, effects or performance of devices that require approval or certification is prohibited until the approval (incl. foreign special approval) or certification is obtained.
What expires, what is retained periodically, and when must renewal start?
Product approvals (承認) and certifications (認証) have no statutory expiry under the PMD Act; the recurring 5-year obligations are the MAH license (Order Art. 36), manufacturer registration (Order Art. 37-7), foreign manufacturer registration (Order Art. 37-13), and QMS conformity survey interval (Order Arts. 37-21/39).
Corrects baseline 'route-dependent product renewal' framing: no product-level renewal event exists.
Foreign manufacturer registration (and likewise domestic manufacturer registration, Order Art. 37-7) runs on a 5-year validity cycle; QMS survey periods under the RCAB route are likewise 5 years (Order Art. 39).
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes to approved items split into: partial-change approval for anything beyond Ordinance-defined minor changes (Art. 23-2-5(13)) and notification for minor (軽微な) changes (Art. 23-2-5(14)); the certification route mirrors this split via the certifying RCAB (Art. 23-2-23(7)/(8)).
Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.
Not minor (thus requiring approval-level change review): adding/changing/deleting intended use or effects; changes to methods for inactivating/removing pathogenic factors; and any change MHLW deems to affect quality, efficacy or safety (Rule Art. 114-25(1)); IVD analogs in Art. 114-25(2) (incl. changes to reaction-system components).
Which clinical or IVD performance evidence or study is required and accepted?
Device approval requires clinical trial results or MHLW-accepted substitute evidence, explicitly including documentation created by analyzing information on individuals' physical/mental conditions obtained from medical care (real-world data); clinical trials must satisfy device GCP Ordinance No. 36/2005.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device (医療機器) is a machine, instrument or similar article intended for diagnosis, treatment or prevention of disease in humans or animals, or to affect body structure or function, designated by Cabinet Order; regenerative medicinal products are excluded.
IVDs are regulated as 体外診断用医薬品 (in-vitro diagnostic drugs): drugs used solely for disease diagnosis that are not applied directly to the human or animal body. Their approval, MAH licensing, manufacturer registration and postmarket rules follow the medical-device chapter of the PMD Act (e.g., Arts. 23-2, 23-2-3, 23-2-4, 23-2-5).
Device-chapter provisions consistently read 「医療機器又は体外診断用医薬品」.
Software that is a medical device (医療機器プログラム) is explicitly in scope: providing it over telecommunication lines constitutes marketing (製造販売) and is regulated like any other device marketing.
Same treatment in the distribution-license provision (Art. 39(1)).
Which evidence, local deltas, formats, and signatures are required?
Nonclinical safety data must meet device GLP Ordinance No. 37/2005 and clinical trial data device GCP Ordinance No. 36/2005 (both 2005 MHLW Ordinances), plus data-integrity requirements (accurate creation; handling of unfavorable findings).
Postmarket survey plans reference PMSP Ordinance No. 38/2005 via Rule Art. 114-19(1) ト.
Device approval dossier (Rule Art. 114-19) comprises: development history incl. foreign use status; design and development verification; conformity to Art. 41(3) standards; risk management; manufacturing method; clinical trial results or MHLW-accepted substitutes (incl. documentation analyzed from real-world clinical data); postmarket survey plan (PMSP Ordinance 38/2005); and safety-information/labeling documentation. Application on form 様式第六十三の八 with MAH license copy (Rule Art. 114-17).
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Only holders of the class-matched MHLW marketing license may market devices/IVDs as MAH: 高度管理医療機器 → 第一種医療機器製造販売業許可; 管理医療機器 → 第二種; 一般医療機器 → 第三種; IVDs → 体外診断用医薬品製造販売業許可.
MAH = 製造販売業者 (marketing authorization holder).
A foreign manufacturer of certified designated products must notify the certifying registered certification body within 30 days of changing its appointed Japan MAH (or changes to the MAH's details) (Art. 23-3(2)); MAH-side events such as business suspension/closure or changes to the 総括製造販売責任者 are notified to MHLW within 30 days (Art. 23-2-16(1)).
Changing the appointed MAH is a notification, not a re-certification; transfer of approval itself runs through separate change/inheritance procedures.
Foreign manufacturers of devices/IVDs exported to Japan register each manufacturing site with MHLW (医療機器等外国製造業者登録); product approval is refused if the manufacturing site lacks domestic registration (Art. 23-2-3) or foreign registration (Art. 23-2-4) (Art. 23-2-5(2)(ii)).
Registration per manufacturing site (製造所ごと).
Which establishment licences, importer permissions, and distribution controls apply?
Selling, granting, leasing (or displaying for such purposes) 高度管理医療機器 (Class III/IV) or 特定保守管理医療機器 requires a distribution or leasing license (販売業/貸与業許可); providing the equivalent device programs over telecommunication lines is equally covered.
MAHs and manufacturers supplying downstream licensed entities are excepted within the same paragraph.
An MAH importing devices/IVDs for marketing must, by the time of customs clearance, hold a document proving for each product that an approval or approval application, a notification, a foreign special approval (or application), or a certification (or application) exists.
Items (1)-(4) of the paragraph list the four qualifying statuses.
Domestic entities manufacturing devices/IVDs as a business — including design — must register each applicable manufacturing site (design, assembly, sterilization or other Ordinance-designated processes) with MHLW.
Registration is a condition for product approval (Art. 23-2-5(2)(ii)).
Which label and IFU elements, languages, symbols, and translation controls apply?
When marketing, the MAH must publish current precautions/safety information (注意事項等情報), based on the latest literature and other knowledge, by electronic/ICT means — the statutory basis of the electronic package insert (電子添文) system.
PMDA operates the 電子添文 service (res-jp-pmda-eifu).
The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and prescribed precautions for designated devices.
Which current law, regulation, guidance, and transition provisions apply?
Core framework: Pharmaceuticals and Medical Devices Act (Act No. 145 of 1960, as amended), with Enforcement Cabinet Order No. 11/1961, Enforcement Rule No. 1/1961, QMS Ordinance No. 169/2004 (manufacturing/quality control) and GVP Ordinance No. 135/2004 (postmarket safety management).
Act references: 昭和三十五年法律第百四十五号.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
MAH postmarketing safety management (製造販売後安全管理) must comply with MHLW Ordinance No. 135 of 2004 (GVP), the standards designated under Arts. 12-2(1)(ii), 23-2-2(1)(ii) and 23-21(1)(ii) of the PMD Act.
For MHLW-designated devices/IVDs, the approval holder must apply within 3 months after the end of the MHLW-directed survey period for the use-results evaluation (使用成績評価) — the re-examination of the approval.
Conditional approvals carry their own survey conditions (Art. 23-2-6-2).
Which current form, portal, account, and submission package must be used?
Current online submission surfaces: PMDA electronic submission data system (gateway system, esg.pmda.go.jp), MHLW FD申請 (web.fd-shinsei.mhlw.go.jp), and the medical device WEB application platform DWAP (www.dwap.pmda.go.jp) for device programs/submissions.
Gateway = 申請電子データシステム（ゲートウェイシステム）.
Which QMS, audit, inspection, and certificate scope is accepted or required?
For designated products, the manufacturer must undergo a document-based or on-site QMS conformity survey (書面/実地調査) by MHLW when seeking approval and again every Cabinet-Order period (not less than 3 years; set at 5 years — Order Arts. 37-21 and 39); successful survey yields the 基準適合証 (conformity certificate).
5-year survey interval set by Enforcement Order Arts. 37-21 (MHLW route) and 39 (RCAB route).
Japan QMS is set by MHLW Ordinance No. 169 of 2004 (医療機器及び体外診断用医薬品の製造管理及び品質管理の基準), the standards referenced in Art. 23-2-5(2)(iv) (also applied to foreign special approvals via Art. 23-2-17(5)); conformity is verified by MHLW/PMDA or RCAB surveys — a plain ISO 13485 certificate is not a substitute, while MDSAP results can streamline the survey (from 2022-04-01).
Which recall, FSCA, notice, and authority-coordination duties apply?
MHLW or prefectural governors may order persons handling devices to dispose of, recall, or take other measures sufficient to prevent public-health danger (e.g., defective devices, products whose approval was revoked).
Recalls by MAHs/foreign special-approval holders are reported promptly after initiation to MHLW (or prefectural governor where delegated) with specified items (recaller, product identifiers incl. approval/certification/notification numbers, lots/quantities, sites, export destinations, initiation date, method, planned completion, further measures), plus change reports and prompt completion reporting.
Statutory basis: PMD Act Art. 68-11. (Brief's hint 'Rule 228-15' is incorrect for recalls.)
Which registration, notification, listing, reliance, or conformity route applies?
Approval applications (new and partial change), except Cabinet-Order-designated exceptions, are submitted through PMDA (機構を経由).
MHLW-designated 高度管理医療機器/管理医療機器/IVDs (指定高度管理医療機器等) are certified product-by-product by a registered certification body (登録認証機関); foreign manufacturers market through a Japan MAH they appoint (選任製造販売業者).
Covers most Class II devices and designated Class III/IV products.
A foreign manufacturer of approval-route devices exported to Japan may itself hold the approval (外国製造医療機器等特例承認, Art. 23-2-17): MHLW grants approval product-by-product for marketing through a Japan MAH the foreign manufacturer appoints (選任製造販売業者).
Alternative to a Japan-owned MAH holding the approval.
Route depends on class/designation: Class III/IV (高度管理医療機器) and non-designated products require product-by-product MHLW approval (承認, Art. 23-2-5(1)); MHLW-designated products (mainly Class II 管理医療機器 and designated IVDs, some Class III) require third-party certification (認証) by a registered certification body (Art. 23-2-23(1)); remaining Class I (一般医療機器) need only prior notification (届出, Art. 23-2-12(1)). QMS conformity assessment applies separately.
Notification form: 様式第六十三の二十一 (Rule Art. 114-47).
Devices and IVDs outside the approval and certification designations (i.e., Class I 一般医療機器 and non-designated IVDs) are marketed after a prior product notification (届出) to MHLW by the MAH.
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.
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.
Prior approval / evidence record
geo:aus
Japan MHLW/PMDA Ninsho or Shonin
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
Yes
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.
US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2024-11-22
Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."
Prior approval / evidence record
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
Prior approval / evidence record
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Origin Country Evidence
Evidence Only
classification
Yes
Yes
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
Regulatory reference
Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity-assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
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
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
No
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.
Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
Prior approval / evidence record
Japan MHLW
Yes
Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Japan Ministry of Health, Labour and Welfare (MHLW) pre-market approval (Shonin) is the accepted Japanese reference authorization under the optimized review procedure.
Effective from 2024-06-03
Correction: the official IN 290/2024 list names only 'Japan Ministry of Health, Labour and Welfare (MHLW) - Pre-market approval (Shonin)'. PMDA and the Ninsho category are not named in the Brazilian list.
Prior approval / evidence record
Optimized analysis (procedimento otimizado, IN 290/2024)
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
In at least one Ministry of Health procurement, equipment must comply with one of five named international safety standards — US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. This is a tender technical requirement for the supply of equipment, not a market-authorisation recognition rule: it creates no registration pathway, shortens no review, and does not name Japan PMDA, Korea MFDS or China NMPA.
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
Procurement Admission
Evidence Only
procurement
No
No
Verbatim from the tender document (44 pages, text layer, retrieved HTTP 200, 629,727 bytes): 'The equipment must comply to either one of the five international safety standards namely; US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. The equipment must also comply with relevant AAMI Standards such as UL2601 and IEC601-1.' Searches of the document for 'PMDA', 'MFDS', 'NMPA', 'Korea' and 'China' return no matches, which is why the sourceApproval string does not name those authorities. The bounded claim recorded in value is deliberately limited to what this one procurement states.
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
class-iia
Class IIa
medium
Registration (NSO)
2
2
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
1
2
months
2
3
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iib
Class IIb
high
Registration (RSO)
90
90
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
6
12
months
4
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Japan MHLW
Yes
Reference-country origin under Decreto 3275/2009
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For imported devices, a certificate from the competent authority of the country of origin stating the product is authorized for production or marketing there is required; if the product is not used in the country of origin, a free-sale certificate from a reference country (EU, United States, Canada, Japan, Australia) or a country with a mutual recognition agreement is required instead.
Prior approval / evidence record
Homologación for reference countries (Decreto 3275/2009)
Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.
None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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).
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.
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.
Prior approval / evidence record
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
Yes
Eligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.
No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Japan PMDA and Korea MFDS
No
Neither is named in the Resolución No. 000004 recognition list — Japan appears there only as NIHS — so a PMDA or MFDS marketing approval confers no simplified-procedure eligibility and the application is assessed under the ordinary route. DIGEMAPS' IMDRF affiliate membership creates no recognition route.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure.
WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2016-04-01
Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.
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
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
Regulatory reference
Japan is a reference country (Technical Committee decision of March 2011); the same registration procedures as EU classes I, IIa, IIb and III apply to Japanese classes I, II, III and IV respectively. Japanese documents and labelling must be translated into English (by the Japanese manufacturer or an accredited Egyptian translation office).
Effective from 2023-08-29
A parallel procedure exists for UKCA-marked devices (CAMD index, 07/2023 v02).
Prior approval / evidence record
A medical device that already holds a marketing authorisation, registration certificate or free-sale certificate from one of the authorities EFDA lists as a Stringent Regulatory Authority can be filed on the SRA route (EFDA/GDL/046 §9.4). The applicant still submits the complete administrative and technical dossier required by the ordinary registration guidelines, but EFDA reviews it as a verification exercise focused on the genuineness of the submitted information rather than a de-novo assessment, so the application takes shorter processing time. EFDA keeps the right to conduct a full assessment and to request further information whenever it deems necessary.
US FDA marketing authorisation / registration certificate / free-sale certificate; Japan MHLW; Australia TGA; Singapore HSA; a competent authority of one of the 27 EU Member States (Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017); UK MHRA; Health Canada; South Korea MFDS
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2026-06-25
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). 1. A Marketing Authorization certificate or registration certificate or free sale certificate issued by one of the following competent national regulatory authority: US Food and Drug Administration; Ministry of Health, Labour and Welfare, Japan; Trapeutic Goods Administration, Australia; Health Science Authority, Singapore; Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017.; Medicine and Healthcare Products Regulatory Agency, UK; Health Canada, Canada; Ministry of Food and Drug Safety, South Korea'. The passage also states: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.' Typographical errors are reproduced as they appear in the source.
Prior approval / evidence record
Guatemala does operate a reliance route: Norma Técnica 77 versión 8-2023 homologates a Guatemalan health registration on a registration already granted by a WHO-listed authority of high maturity and performance (WLA/ACO, ML3+). Article 2 confines that route expressly to pharmaceutical specialities of chemical synthesis and to vaccines (biological and biotechnological). It does not reach medical devices or in vitro diagnostics.
Approval by a WHO-listed authority (WLA/ACO, maturity level 3 or above) — e.g. US FDA, EMA, Japan PMDA, Korea MFDS — for chemical-synthesis medicines and vaccines only
Abridged Or Recognition Route
none
Premarket Review
Yes
Yes
Spanish source (Guatemala). Translation: "Article 2. Scope of application. This Technical Norm applies to pharmaceutical specialities of chemical synthesis and vaccines (biological and biotechnological) that hold a Health Registration granted by high-maturity-and-performance Regulatory Authorities as defined by the World Health Organization (WHO), published in the official lists of the Department of Regulation and Control of Pharmaceutical and Related Products, hereinafter THE DEPARTMENT." The norm's own title is 'HOMOLOGACIÓN DEL REGISTRO SANITARIO DE MEDICAMENTOS Y VACUNAS'. Art. 4.3 of the same norm defines the WLA/ACO concept and states that authorities reaching at least general maturity level 3 (ML3) qualify.
Prior approval / evidence record
WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)
No
A foreign marketing approval is not among the NT-37 Art. 5.1 dossier items and opens no recognition route for devices. A Certificate of Free Sale from any competent origin-country authority is required paperwork, and a manufacturing-guarantee certificate from a named authority (FDA, DGKC, IFCC, ISO or a GMP certificate) satisfies one dossier item (NT-37 Arts. 5.1.5-5.1.6 and 6.12.6). The full local review still runs.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Japan MHLW / registered certification body
Yes
Approval or certification satisfies D002
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).
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
Japan PMDA
Yes
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-a
Class A
low
Registration
45
45
days
official-verified
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
2026-08-25
6
9
months
3
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.
Effective from 2018-01-01
G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.
Regulatory reference
PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities while retaining authority for final approval. Eligible reference mechanisms listed include WHO Prequalification Programme / Collaborative Registration Procedure, Stringent Regulatory Authorities (US FDA, EMA, Health Canada, Swissmedic, PMDA Japan, TGA Australia) and the East African Community Medicines Regulatory Harmonization (EAC-MRH).
Regulatory reference
The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).
Prior approval / evidence record
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
Yes
Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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
The Lebanese assessment of an implantable device does not address the clinical-evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re-reviewed in Lebanon.
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Assessment Report Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."
Prior approval / evidence record
To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist.
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."
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
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
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
Yes
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
Special-access-type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non-commercial exemptions.
Regulatory reference
Pre-market certification (Ninsho) from a Japanese registered certification body or pre-market approval (Shonin) from MHLW qualifies for the verification route.
Prior approval / evidence record
class-b
Class B
medium
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Prior approval / evidence record
class-d
Class D
highest
Full Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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
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
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
geo:mex
Japan MHLW/PMDA Ninsho or Shonin
Equivalence Or Abridged Review
facilitated
Product Marketing
Yes
Yes
Same COFEPRIS-04-050 mechanism as other ARR approvals under the Lineamientos.
Effective from 2025-07-19
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
Japan PMDA
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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
Japan PMDA / Korea MFDS / other non-listed approvals
No
No Moroccan device instrument examined in this round names them, and the AMMPS reliance framework is scoped to medicines and vaccines, so they carry no listed documentary route for a device.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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
The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
Regulatory reference
Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.
Effective from 2018-01-16
Prior approval / evidence record
A device that has no Paraguayan sanitary registration may be imported for compassionate use where it has been authorised by a foreign reference regulatory agency included in the annual official list under Ley N° 7256/2024, and is required to treat a patient or group of patients urgently as determined by the treating specialist or the MSPBS. The route is an import authorisation, not a registration.
Authorisation by a foreign reference regulatory agency included in the Listado Anual Oficial under Ley N° 7256/2024 (2026 list: US FDA, EU Commission/EMA, Japan MHLW/PMDA, Korea MFDS, ANMAT, ANVISA, ISP and others)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-06-30
Source language: Spanish. Translation: 'Medicines or medical devices Registered by a Regulatory Authority: Medicines or medical devices that have been authorised by a foreign reference regulatory agency included in the official annual list pursuant to Law N° 7256/2024 or its updates, that do not have a sanitary registration issued by DINAVISA and that are required to treat a patient or group of patients urgently, determined by the treating specialist physician, or the Ministry of Public Health and Social Welfare.' Art. 12 (OCR renders it 'Artículo 129') sets the resolution in force from 30 June 2025.
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
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
The Listado Anual Oficial that Res. 226/2024 Art. 8(a) incorporates by reference does name US FDA, the European Commission (DG SANTE)/EMA, Japan MHLW/PMDA and Korea MFDS — but every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos médicos, so on the published instrument the simplified device route is not anchored to any device-scoped reference authority.
none
International Listing
none
Premarket Review
Yes
Yes
Effective from 2026-05-01
Source language: Spanish. Translation of the quoted entries: 'United States: US FDA. Scope: Medicines and vaccines.' / 'European Commission (DG SANTE); European Medicines Agency (EMA); National Regulatory Authorities. Scope: Medicines and vaccines.' / 'Republic of Korea: Ministry of Food and Drug Safety (MFDS). Scope: Medicines and vaccines.' / 'Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA). Scope: Medicines' and a second Japan entry 'Pharmaceuticals and Medical Devices Agency (PMDA). Scope: Vaccines'. The resolution is dated 'de mayo de 2026'; the day glyph is illegible in the scan and is not reproduced. effectiveFrom is the month of signature only.
Prior approval / evidence record
A class II, III or IV medical device already authorised by an authority of a country on the Listado Anual Oficial (emitted under Ley N° 7256/2024 Art. 3) or by an authority with a published bilateral recognition agreement enters the 'Proceso simplificado de Registro Sanitario' instead of full integral analysis. The applicant still files every Art. 6 requirement and still needs a Paraguayan registration, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier.
Any marketing authorisation issued by an authority of a country on the Listado Anual Oficial — the 2026 list (Resolución DINAVISA N° 182/2026) names US FDA, European Commission (DG SANTE)/EMA and EU national authorities, Japan MHLW/PMDA, Korea MFDS, Singapore HSA, Indonesia BPOM, ANMAT, ANVISA and ISP — each entry stated as scoped to medicamentos and/or vacunas
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-09-16
Source language: Spanish. Translation: 'Applications for registration of products classified by DINAVISA as class II, III and IV medical devices that are authorised by authorities of the countries on the Annual Official List emitted in Resolución DINAVISA N° 148/2024 and its updates, as well as those Regulatory Authorities with which bilateral agreements for the recognition of authorisations exist, which so provide, published on the DINAVISA website, shall be subject to the simplified Sanitary Registration Process.' OCR of the two-column official PDF was normalised: 'Clase l' rendered as 'Clase II' and 'N*148/2024' as 'N°148/2024'.
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
Regulatory reference
For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Rwanda FDA operates an abridged assessment procedure for medical device registration. Abridged assessment is defined as a limited independent assessment of specific parts of the dossier, taking into account prior assessment (dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority the Authority deems competent. The cover letter template for an abridged application (Appendix 1 of DHT/GDL/024) requires the applicant to confirm that the product dossier submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC. The statutory basis is Article 16 of the device registration regulations, which allows the Authority to rely on regulatory decisions of regional, international and other stringent regulatory authorities for product market authorisation. For devices under abridged assessment, QMS compliance of the manufacturing site is confirmed by desk review rather than an on-site inspection, although the Authority may still conduct an on-site inspection if necessary.
US FDA; EU CE marking under MDR 2017/745 / IVDR 2017/746 or the predecessor directives; Japan PMDA/MHLW; Korea MFDS; and any other authority the Rwanda FDA deems competent under the SRA concept, where the product is registered with that authority as an SRA; WHO Prequalification; EAC registration
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2025-11-01
Verbatim (Glossary 2): "'Abridged assessment' a limited independent assessment of specific parts of the dossier, or regulatory submission of data for suitability of use under local conditions and regulatory requirements, taking into account prior assessment (including dossier review and/or independent performance evaluation) and inspection outcomes from WHO prequalification or any National Regulatory Authority (NRA) deemed by the Authority as competent to inform the latter in its decision." Verbatim (application form): 'I confirm that the Product Dossier information submitted is the same in all aspects as the product registered with the relevant SRA, WHO PQ and EAC (Only for Abridged Applications)'.
Prior approval / evidence record
FDA 510(k) / PMA, EU CE marking, Japan PMDA, Korea MFDS
Yes
Handled through the SRA concept rather than by a substitute approval; the Rwandan registration and certificate are still issued by Rwanda FDA and the reliance decision is discretionary.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
class-c
Class C
high
IBR/Expedited/Full Route
0
220
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
6
12
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
IBR/Expedited/Full Route
0
160
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
3
9
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
Yes
At Class B this is the IBR trigger and registration is granted on submission. At Class C and D it is the ECR-2 or EDR trigger.
Class B immediate against 160 working days; Class C 120 against 220; Class D 180 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada, Australia TGA, Japan MHLW
Yes
A Canadian or Australian device registration licence, or a Japanese Ninsho certification or Shonin approval, counts as a reference approval on the same terms as the US and EU.
Same as the abridged route figures above; two of them together trigger IBR, ECR-2 or EDR
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Japan MHLW/PMDA is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for the reliance-based registration routes.
Confirms baseline reliance edge.
Prior approval / evidence record
class-d
Class D
highest
IBR/Expedited/Full Route
180
310
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
9
18
months
6
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre-market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.
The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.
Regulatory reference
For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.
Prior approval / evidence record
QSD Abbreviated Pathway
Abbreviated QMS review for USA/EU/Japan manufacturers
2-3 months faster
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-ii
Class II
medium
Registration
140
140
days
official-verified
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
2026-08-17
2026-08-29
9
14
months
6
9
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-iii
Class III
highest
Registration with clinical data
200
200
days
official-verified
TFDA people’s application handling-period table (FDA器字第1151604804號) — Class I 80, Class II 140, Class III 200 calendar days
https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31695
2026-08-17
2026-08-29
12
18
months
8
11
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Japan PMDA
Yes
Fast-track pathway
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
Japan MHLW/PMDA Ninsho or Shonin
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Japan PMDA / Korea MFDS / other non-listed approvals
No
Not named anywhere in the ANMPS device dossier guide: a product holding only a PMDA or MFDS approval has no listed documentary route and must rely on the agency's reservation clause permitting it to request other documents.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
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
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
Uganda treats recognised-country certification as an eligibility gate, not merely as evidence. DAR/GDL/028 s. 4.11 states that devices not certified by any of the recognised countries will be examined and may be exempted from recognised-country certification only if they are class A; for other classes the recognised-country or CE certification is a must. The recognised countries are the United States (FDA clearance/approval), Canada, Japan (MHLW clearance/approval) and Europe. For Europe the certificate required scales with class: full quality assurance / EC Type Examination Certificate for class B and C, and full quality assurance / EC Design Examination Certificate for class D, and the notified body must itself be approved by European health authorities.
US FDA clearance/approval; Canada clearance/approval; Japan MHLW clearance/approval; Europe EC quality-system certification with an EC Type Examination Certificate (class B and C) or EC Design Examination Certificate (class D) issued by a notified body approved by European health authorities
Eligibility Gate
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt is a contiguous verbatim run from s. 4.11 with the class-by-class European detail joined by [...]. edgeType 'eligibility_gate' is reused from the existing vocabulary (1 prior use) rather than inventing a token: the mechanism is that recognised certification is a precondition for classes B-D, which is what that token means. marketAccessStrength is 'facilitated' rather than 'evidence_only' because holding the certificate changes which applications can be accepted at all, not just how much paperwork is filed. There is an internal tension in the source between s. 4.11 (certification is a must for classes B-D) and s. 4.12.3 (Track 3 for products with no certification to any listed quality system standard); both are recorded, and the tension is stated in conditions rather than resolved by assumption.
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
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
Yes
DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
FDA (with TGA Australia, ANVISA Brazil, Health Canada, and MHLW/PMDA Japan) participates in the Medical Device Single Audit Program and may accept MDSAP audit reports as a substitute for routine Agency inspections; firms with Electronic Product Radiation Control (EPRC) activities remain subject to direct FDA inspection for those activities.
MDSAP official documents moved to the TGA-managed MDSAP website (FDA update of 2025-12-18).
Regulatory reference
Devices registered by the following are registered in Uzbekistan by the recognition route: US FDA; EU bodies authorized to issue CE conformity certificates; EMA (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (United Kingdom). Foreign certificates are verified against the issuing regulator's official registers/website; if not verifiable through open sources they must be apostilled or consularly legalized.
Effective from 2026-02-26
WHO-prequalified IVDs registered in cooperation with WHO get a separate 60-working-day route.
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
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
Priority Review (優先審査)
Expedited review for serious conditions
9-month guide, or 10 months at the 80th percentile under the mid-term plan, against 12 and 14 for ordinary new devices
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
MDSAP
Yes
Single audit satisfies PMDA QMS
3-6 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
SAKIGAKE Designation (先駆け審査指定制度)
Pioneer designation for devices developed in Japan first, carrying prioritised consultation and a dedicated PMDA concierge
6-month total review target, against the 12-month guide for an ordinary new device
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Devices already approved in a country with an approval system of equivalent standard to Japan's qualify for priority add-on processing (faster review and surveys ahead of other products, Art. 23-2-5(9)); the only designated country is the United States.
US-only reliance edge for expedited review; does not create automatic approval.
Prior approval / evidence record
FDA 510(k)
No
STED documentation can be adapted; no abridged Japanese period
2-4 months prep
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
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。
Prior approval / evidence record
EU CE Mark
No
ISO 13485 applicable to Ordinance 169; no abridged Japanese period
2-4 months prep
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
PMDA accepts MDSAP audit results and, where appropriate, streamlines the survey procedures for QMS conformity-survey applications (evidence reuse at the QMS-audit layer only; a local QMS conformity decision and product authorization are still required).
Effective from 2022-04-01
effectiveFrom stated on page: 2022年4月1日.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
MHLW may grant conditional approval (条件付承認) for rare-disease (希少疾病用), pioneer (先駆的) or special-use (特定用途) devices/IVDs, attaching conditions including implementation of Ordinance-defined postmarketing surveys.
Survey results feed the 使用成績評価 process (Art. 23-2-9).
緊急承認: MHLW may approve devices/IVDs needed urgently to prevent spread of serious health harm where no adequate alternative exists, attaching use-assurance conditions and a term not exceeding 2 years (extendable under the same article).
Re-application required at term end.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Applicants can file a formal appeal (審査請求) with MHLW against PMDA dispositions (other than review results) or inaction in medical-device reviews; MHLW is treated as PMDA's superior agency for the appeal.
Which UDI, device listing, database, and traceability duties apply?
Device containers/wrappers must bear a number, symbol or code (符号) — by an Ordinance-prescribed electronic/ICT method — enabling retrieval of the published precautions (注意事項等情報); this is the statutory basis for GS1-code (UDI-style) device identification.
PMDA operates electronic package inserts (電子添文) and a registration linking device/IVD package inserts with GS1 codes (introduced by MHLW notification of 2020-11-11, 薬生安発0311第1号), enabling code-based retrieval of current IFU information.
Notice dated 2020-11-11 on page.
What is reportable, by whom, where, in what format, and by what deadline?
Device MAHs and foreign special-approval holders report to MHLW: within 15 days — malfunction-suspected deaths, serious cases unpredictable from precautions (incl. foreign identical-device malfunctions), infections, and foreign recall/suspension measures; within 30 days — other serious cases/malfunctions and trend changes; periodically — within 2 months after each 1-year period from approval (malfunctions with foreseeable death/serious risk and other specified trends).
30-day categories in item 二 and periodic report in item 三 of the same paragraph.
The ADR/safety-information reporting duty lies on the MAH and on foreign special-approval holders (外国特例承認取得者); healthcare professionals have a separate reporting duty (Art. 68-10(2)).
japan:medical-device
japan
Risk classes I through IV.
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
PMDA
official-source-verified
Pharmaceuticals and Medical Devices Act (Act No. 145 of 1960), Art. 2(5)-(8)
https://elaws.e-gov.go.jp/document?lawid=335AC0000000145
2026-08-25
Japan
japan
JP
🇯🇵
Pharmaceuticals and Medical Devices Agency
PMDA
asia-pacific
1
4-class (I, II, III, IV)
class-i
Class I (一般医療機器)
low
Pre-marketing notification (製造販売届, Todokede) to PMDA
0
0
days
official-verified
PMDA — Class I pre-marketing notification procedure (製造販売届に関する手続き)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0016.html
2026-08-30
0
0
days
No
No
No
certification-ninsho
Third-party certification (認証)
Registered certification body (登録認証機関) under Art. 23-2-23
0
0
days
official-verified
PMDA — registered certification body scheme (登録認証機関制度), MHLW notice 医薬機審発0306第1号
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0025.html
2026-08-30
5
6
months
No
No
Yes
approval-new-device
New medical device application (新医療機器)
PMDA approval review (Shonin)
12
12
months
official-verified
PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0035.html
2026-08-30
7.1
12
months
Yes
approval-improved-clinical
Improved device — clinical data (改良医療機器（臨床あり）)
PMDA approval review (Shonin)
9
9
months
official-verified
PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0035.html
2026-08-30
6.5
8.8
months
Yes
Yes
approval-improved-nonclinical
Improved device — no clinical data (改良医療機器（臨床なし）)
PMDA approval review (Shonin)
6
6
months
official-verified
PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0035.html
2026-08-30
4.9
7.3
months
Yes
approval-follower
Follower medical device application (後発医療機器)
PMDA approval review (Shonin)
4
4
months
official-verified
PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0035.html
2026-08-30
2
6
months
Yes
SAKIGAKE Designation (先駆け審査指定制度)
Pioneer designation for devices developed in Japan first, carrying prioritised consultation and a dedicated PMDA concierge
6-month total review target, against the 12-month guide for an ordinary new device
Priority Review (優先審査)
Expedited review for serious conditions
9-month guide, or 10 months at the 80th percentile under the mid-term plan, against 12 and 14 for ordinary new devices
FDA 510(k)
No
STED documentation can be adapted; no abridged Japanese period
2-4 months prep
EU CE Mark
No
ISO 13485 applicable to Ordinance 169; no abridged Japanese period
2-4 months prep
MDSAP
Yes
Single audit satisfies PMDA QMS
3-6 months
Yes
Marketing Authorization Holder (MAH)
Yes
Single audit satisfies PMDA QMS requirements
The approval, certification or notification itself does not expire. What expires around it is the paperwork: the marketing-authorisation licence is renewed every 5 years, and the QMS conformity investigation must be repeated on a 5-year cycle. New devices additionally carry a re-examination period fixed at approval
official-verified
PMDA target review periods for medical devices (申請区分ごとの審査期間の目安)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0035.html
2026-08-30
PMDA — Class I pre-marketing notification procedure (製造販売届に関する手続き)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0016.html
2026-08-30
PMDA — registered certification body scheme (登録認証機関制度), MHLW notice 医薬機審発0306第1号
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0025.html
2026-08-30
PMDA standard review process timeline — new medical devices (新医療機器に係る承認審査の標準的プロセスにおけるタイムライン)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0022.html
2026-08-30
PMDA standard review process timeline — improved devices with clinical data (改良医療機器（臨床あり）)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0033.html
2026-08-30
PMDA standard review process timeline — improved devices without clinical data and follower devices (改良医療機器（臨床なし）及び後発医療機器)
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0034.html
2026-08-30
PMDA submission to the 21st MHLW periodic exchange — mid-term-plan total review period targets and tile values by application category
https://www.mhlw.go.jp/content/11124500/001152090.pdf
2026-08-30
2026-08-30
2026-08-30
japan
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Device Classification
Classify device under PMDA rules: Class I (Todokede), II-III (Ninsho), III-IV (Shonin).
2-4 weeks
🏷️
2
Appoint MAH/DMAH
Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) in Japan.
4-8 weeks
🏛️
3
Foreign Manufacturer Accreditation
Register foreign manufacturing site with PMDA. Required before product registration.
1-2 months
🏭
4
QMS Compliance
PMDA conducts QMS/GMP audit of manufacturing site. MDSAP accepted as alternative.
2-4 months
⚙️
5
Pre-Submission Consultation
Recommended for Class III/IV devices. Discuss clinical data and testing requirements.
1-3 months
💬
6
Shonin/Ninsho Application
Submit application to PMDA (Shonin) or Registered Certification Body (Ninsho).
1-2 weeks
📤
7
PMDA Review
Technical review by PMDA. Average 10-14 months for Shonin (Class III-IV).
10-14 months
🔍
8
Approval
MHLW issues approval. Device can be marketed in Japan through the MAH.
2-4 weeks
✅
Japan
japan
JP
PMDA
1879900
3080600
JPY
Yes
1879900
17721200
JPY
Yes
shonin-class-ii-iii-follow-on
Shonin - Class II/III (Follow-on)
JPY
1879900
¥1,879,900
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
shonin-class-iv-follow-on
Shonin - Class IV (Follow-on)
JPY
3080600
¥3,080,600
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
shonin-class-ii-iii-new-no-clinical
Shonin - Class II/III (New, no clinical)
JPY
11816400
¥11,816,400
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
shonin-class-iv-new-no-clinical
Shonin - Class IV (New, no clinical)
JPY
16520700
¥16,520,700
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
shonin-class-ii-iii-new-clinical
Shonin - Class II/III (New, clinical)
JPY
13016900
¥13,016,900
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
shonin-class-iv-new-clinical
Shonin - Class IV (New, clinical)
JPY
17721200
¥17,721,200
Per approval
exact-current
official-verified
https://www.pmda.go.jp/files/000241084.pdf
PMDA medical-device review and QMS fee table
2026-08-25
government-application-fee-high-risk
Government application fee for device approval - categories (1)-(2) high-risk applications
JPY
100000
JPY 100,000
Per application
Fee Order Art. 12; paid to the government in addition to the PMDA review fee.
exact-current
official-verified
https://elaws.e-gov.go.jp/document?lawid=417CO0000000091
Japan Cabinet Fee Order (e-Gov): application fee Art. 12 and PMDA review fee Art. 33
2026-08-25
government-application-fee-set-standards
Government application fee - category (5) designated devices with set review standards
JPY
33300
JPY 33,300
Per application
exact-current
official-verified
https://elaws.e-gov.go.jp/document?lawid=417CO0000000091
Japan Cabinet Fee Order (e-Gov): application fee Art. 12 and PMDA review fee Art. 33
2026-08-25
2026-08-25
official-verified
PMDA medical-device review and QMS fee table
https://www.pmda.go.jp/files/000241084.pdf
2026-08-25
Japan Cabinet Fee Order (e-Gov): application fee Art. 12 and PMDA review fee Art. 33
https://elaws.e-gov.go.jp/document?lawid=417CO0000000091
2026-08-25
2026-08-25
exact-current
Yes
japan
Japan
high
pmda-mhlw-electrical-emc-evidence
PMDA/MHLW electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
Approval dossiers must include conformity data for the standards MHLW sets under Art. 41(3) (essential principles incl. JIS-based safety standards; Enforcement Rule Art. 114-19(1)(ハ)); certification-route products are those MHLW designates by certification standards under Art. 23-2-23(1); Art. 42(2) PMD Act allows hazard-prevention standards on properties, quality and performance beyond the essential principles.
candidate
radio-law-technical-conformity-giteki
Radio Law technical conformity/Giteki
Radio Spectrum
Mandatory If Feature
Radio Equipment
candidate
terminal-equipment-conformity
Terminal equipment conformity
Telecom Network Attachment
Mandatory If Feature
Network Terminal
candidate
pse
PSE
General Electrical Components
Mandatory If Feature
Catalogued Product Or Component
candidate
measurement-act-approval-verification
Measurement Act approval/verification
Legal Metrology
Mandatory If Feature
Specified Measuring Instrument
unresolved
radiation-authorization
Radiation authorization
Ionizing Radiation
Mandatory For Use Site
Facility Or Operator
unresolved
METI
Electrical Appliances and Materials Safety Act/PSE
https://www.meti.go.jp/english/policy/economy/consumer/pse/index.html
e-Gov Japan
Radio Law technical conformity rules
https://laws.e-gov.go.jp/law/356M50001000037?occasion_date=20260403
MIC
terminal equipment conformity
https://www.soumu.go.jp/main_sosiki/joho_tsusin/tanmatu/index.html
e-Gov Japan
PMD Act Art. 42(2) hazard-prevention standards
https://elaws.e-gov.go.jp/document?lawid=335AC0000000145
e-Gov Japan
Enforcement Rule Art. 114-19 standards conformity data
https://elaws.e-gov.go.jp/document?lawid=336M50000100001
