Explore the medical device requirements currently available for South Korea, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
No one may mark or advertise non-device products on their exterior, packaging or accompanying documents in a way likely to mislead that they have performance, efficacy or effects similar to a medical device.
Effective from 2026-07-01
Ads for medical devices using enumerated media (TV/radio broadcasting, daily/weekly/internet newspapers, magazines, banners/posters/leaflets, electronic boards, internet media) must undergo prior deliberation (์์จ์ฌ์) on whether they violate Article 24(2)-(3); deliberation is performed by a self-deliberation body registered with MFDS under Article 25-2.
Effective from 2026-07-01
Prohibited-ad scope detail: ์ํ๊ท์น [๋ณํ 7] ๊ธ์ง๋๋ ๊ด๊ณ ์ ๋ฒ์.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
Manufacturing approval, certification or notification (์ ์กฐํ๊ฐ๋ฑ) is valid for 5 years from the date the approval/certification was granted or the notification was accepted.
Effective from 2026-07-01
The holder must renew the approval/certification/notification with the MFDS Commissioner before the 5-year validity ends; on renewal the validity is newly granted for 5 years and the permit certificate keeps its effect.
Effective from 2026-07-01
e-Medis renewal guidance: ์ ํฉ ์ ๊ฐฑ์ (์ ํจ๊ธฐ๊ฐ ์๋กญ๊ฒ 5๋ ๋ถ์ฌ, ํ๊ฐ์ฆ ํจ๋ ฅ ์ ์ง).
Renewal applications are filed 270 to 180 days before the expiry date (per e-Medis official guidance; the Act itself only requires renewal before expiry and delegates procedure to the Prime Ministerial Decree).
Page also states ํ๊ฐ์ธ์ฆ์ ๊ณ (์ ํจ๊ธฐ๊ฐ 5๋ ๋ถ์ฌ).
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes to approved/certified/notified particulars (e.g. location changes) require change approval (๋ณ๊ฒฝํ๊ฐ), change certification (๋ณ๊ฒฝ์ธ์ฆ) or change notification (๋ณ๊ฒฝ์ ๊ณ ) to the MFDS Commissioner; the procedures and criteria are delegated to the Prime Ministerial Decree.
Effective from 2026-07-01
Which clinical or IVD performance evidence or study is required and accepted?
Devices that are not substantially equivalent, or for which clinical-trial data submission is required, need approval (even in Class 1-2) with clinical data; e-Medis shows the approval clock for clinical-data cases at 80 days versus 65 days for technical-document-only cases.
Clinical trials of medical devices run under an MFDS-approved clinical trial plan (์์์ํ๊ณํ ์น์ธ); investigational devices must be manufactured in facilities meeting Prime-Ministerial-Decree standards (or imported correspondingly).
Effective from 2026-07-01
Conduct standard: ์ํ๊ท์น [๋ณํ 3] ์๋ฃ๊ธฐ๊ธฐ ์์์ํ ๊ด๋ฆฌ๊ธฐ์ค.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device (์๋ฃ๊ธฐ๊ธฐ) is any instrument, machine, apparatus, material or software or similar product used alone or in combination on humans or animals for diagnosis, treatment, alleviation, treatment or prevention of disease (among other listed purposes).
Effective from 2026-07-01
์ 1ํธ: ์ง๋ณ์ ์ง๋จใ์น๋ฃใ๊ฒฝ๊ฐใ์ฒ์น ๋๋ ์๋ฐฉํ ๋ชฉ์ ์ผ๋ก ์ฌ์ฉ๋๋ ์ ํ.
Which evidence, local deltas, formats, and signatures are required?
Approval applications include, where applicable, the technical-documentation review result notification (๊ธฐ์ ๋ฌธ์ ๋ฑ์ ์ฌ์ฌ๊ฒฐ๊ณผํต์ง์) among the required attachments, linking the separate technical-document review to the product application.
Official form [์์ 9] ์๋ฃ๊ธฐ๊ธฐ ๊ธฐ์ ๋ฌธ์ ๋ฑ์ ์ฌ์ฌ๊ฒฐ๊ณผํต์ง์ exists in the Enforcement Rule annex list.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Licensed Importer As Applicant
Korean licensed importer / product authorisation holder
yes
Foreign Device Enters Through Licensed Importer
Same Core Local Role
May Be Separate
Allowed Subject To Business Licences
The importer must hold an import business licence from MFDS and is the party that obtains the product-level import approval/certification/notification.
Effective from 2026-07-01
Manufacturing medical devices as a business requires a manufacturing business licence (์ ์กฐ์ ํ๊ฐ) from the MFDS Commissioner.
Effective from 2026-07-01
Selling or leasing medical devices is a notified business (ํ๋งคยท์๋์ ์ ๊ณ ) with an official notification form (์๋ฃ๊ธฐ๊ธฐ ํ๋งค(์๋)์ ์ ๊ณ ์, [์์ 36]) and a notification fee under Enforcement Rule Annex 10.
Effective from 2026-07-01
Annex 10 OCR row 13 lists a fee for ํ๋งค์ ๋๋ ์๋์ ์ ๊ณ .
Which establishment licences, importer permissions, and distribution controls apply?
Before applying for import approval/certification or filing import notification, the importer must already have the facilities and manufacturing/quality-management system required for quality inspection under the Prime Ministerial Decree.
Effective from 2026-07-01
Which label and IFU elements, languages, symbols, and translation controls apply?
Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking ์๋ฃ๊ธฐ๊ธฐ; (7) for single-use, ์ผํ์ฉ and ์ฌ์ฌ์ฉ ๊ธ์ง markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.
Effective from 2026-07-01
The article text opened does not separately specify marking language; the statutory wording is Korean.
Which current law, regulation, guidance, and transition provisions apply?
Medical Device Act Enforcement Rule (์๋ฃ๊ธฐ๊ธฐ๋ฒ ์ํ๊ท์น), Prime Ministerial Decree No. 2127, in force from 2026-07-01, carries the annexes: grade classification criteria [๋ณํ 1], facility and QMS standards [๋ณํ 2], clinical trial management standards [๋ณํ 3], import-establishment standards [๋ณํ 4], distribution quality management [๋ณํ 6], prohibited advertising scope [๋ณํ 7], fees [๋ณํ 10] and official forms [์์ 1-56].
Effective from 2026-07-01
MFDS administrative rules (๊ณ ์) implement detail, e.g. ใ์๋ฃ๊ธฐ๊ธฐ ํ์ค์ฝ๋์ ํ์ ๋ฐ ๊ด๋ฆฌ์๋ นใ (๊ณ ์ ์ 2023-67ํธ) โ header seen on its law.go.kr page.
Medical Device Act (์๋ฃ๊ธฐ๊ธฐ๋ฒ), Law No. 21263 of 2025-12-30, in force from 2026-07-01, is the primary statute.
Effective from 2026-07-01
Version line appears on all article print pages opened for this jurisdiction.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Re-examination-target manufacturers/importers report survey results annually, within 2 months after each 1-year period from the marketing date; after result notification, follow-up measures must be taken within 30 days.
Page also states: ํต์ง์ผ๋ถํฐ 30์ผ ์ด๋ด์ ์ฌ์ฌ์ฌ ๊ฒฐ๊ณผ์ ๋ฐ๋ฅธ ์กฐ์น.
At product approval MFDS sets the post-market survey (์ํ ํ ์กฐ์ฌ) period, generally 3 months; the re-examination (์ฌ์ฌ์ฌ) period runs within 4 to 7 years after approval and may be extended within that range through the Medical Device Committee.
Which current form, portal, account, and submission package must be used?
e-Medis (์๋ฃ๊ธฐ๊ธฐ์ ์๋ฏผ์์์คํ , emedi.mfds.go.kr) is the official electronic civil-affairs system through which product permits/certifications/notifications and renewals are filed and processed.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Manufacturing-licence applicants/manufacturers and import-business applicants/importers must obtain KGMP conformity certification (์ ํฉ์ฑ์ธ์ ). The certificate is valid 3 years from issuance; changes such as manufacturing-site (including overseas site) relocation require change conformity certification, and the certificate must be renewed before expiry.
Effective from 2026-07-01
National Qms Aligned With Iso Additions
KGMP: national conformity certification (์ ํฉ์ฑ์ธ์ ) under Article 28 of the Act with facility/QMS standards in Enforcement Rule Annex 2; ISO 13485-aligned but retained as national conformity.
Plain ISO 13485 does not replace KGMP conformity certification.
Affiliate Audit Report And Certificate Use
MFDS guideline (2024) governs reuse of MDSAP audit results in GMP reviews.
Effective from 2026-07-01
Corroborated by res-kr-mda-art28 (certification duty) and res-kr-mfds-mdsap (MDSAP reuse).
Which recall, FSCA, notice, and authority-coordination duties apply?
The Enforcement Rule prescribes official recall forms: recall plan (ํ์๊ณํ์, [์์ 43]), recall confirmation (ํ์ํ์ธ์, [์์ 44]), recall evaluation report (ํ์ํ๊ฐ๋ณด๊ณ ์, [์์ 45]) and recall-termination report (ํ์์ข ๋ฃ๋ณด๊ณ ์, [์์ 48]).
Effective from 2026-07-01
MFDS (or the listed local government heads) order manufacturers etc., by hazard degree, to suspend sales, recall, dispose of by public-health protective means, or take other measures, and may publicise the fact; the standards, methods and publicity methods for hazard-degree-based suspension/recall/disposal are delegated to the Prime Ministerial Decree.
Effective from 2026-07-01
Which registration, notification, listing, reliance, or conformity route applies?
Per-item approval (ํ๊ฐ) targets Class 3 and 4 devices, plus listed Class 1-2 exceptions: devices combined with drugs/quasi-drugs, u-healthcare devices, continuously worn respiratory monitors, devices not substantially equivalent or requiring clinical-trial data, devices without notified sub-classification, and new-medical-technology-integrated-review devices.
Importers must obtain import approval (์์ ํ๊ฐ) or import certification (์์ ์ธ์ฆ), or file import notification (์์ ์ ๊ณ ), for each device they import.
Effective from 2026-07-01
Manufacturers obtain product-level manufacturing approval (์ ์กฐํ๊ฐ), manufacturing certification (์ ์กฐ์ธ์ฆ) or file manufacturing notification (์ ์กฐ์ ๊ณ ). Devices with very low potential harm notified by MFDS are handled per product family (ํ๋ชฉ๋ฅ๋ณ); all other devices per individual item (ํ๋ชฉ๋ณ).
Effective from 2026-07-01
Market entry follows the class route: Class 1 notification, Class 2 certification, Class 3-4 approval, plus KGMP conformity certification (์ ํฉ์ฑ์ธ์ ) for the manufacturer/importer as a prerequisite; Class 1 low-risk items may be notified per product family.
Effective from 2026-07-01
Baseline description confirmed with refinement: Class 2 route is certification (์ธ์ฆ) rather than approval.
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 โ state registration or free circulation โ 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 โ US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK โ 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-ี of 30.03.2023, Annex No. 2, para. 2(2)(a): "ีบีฅีฟีกีฏีกีถ ีฃึีกีถึีธึีด ีนีธึีถีฅึีธีฒ ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีซ ีฐีกีดีกึี ีก. ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีซ ีกึีฟีกีคึีธีฒ ีฅึีฏึีธึีด ีฏีกีด ิฒีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีซ ีฏีกึีฃีกีพีธึีธีฒ ีดีกึีดีซีถีถีฅึีซ ีดีซีปีกีฆีฃีกีตีซีถ ีฐีกีดีกีชีธีฒีธีพีซ (IMDRF) ีกีถีคีกีด ีฅึีฏึีถีฅึีธึีด ีฏีซึีกีผีดีกีถ ีฉีธึีตีฌีฟีพีธึีฉีตีธึีถีจ (ีบีฅีฟีกีฏีกีถ ีฃึีกีถึีธึีดีจ, ีกีฆีกีฟ ีฏีซึีกีผีธึีดีจ) ีฐีกีพีกีฝีฟีธีฒ ึีกีฝีฟีกีฉีธึีฒีฉ ีฏีกีด ีคึีก ีพีฅึีกีขีฅึีตีกีฌ ึีกีฝีฟีกึีฏีพีกีฎ ีฟีฅีฒีฅีฏีกีถึ, ีกีตีค ีฉีพีธึีดี ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีซ ีฐีกีดีกีบีกีฟีกีฝีญีกีถีธึีฉีตีกีถ ีฐีกีตีฟีกึีกึีกีฃีซึ (Declaration of Conformity) ีฐีกีดีกีบีกีฟีกีฝีญีกีถ ีฃึีกีถึีกีดีกีฟีตีกีถีถีฅึีซ ีฐีฒีธึีดีธีพ". 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 โ the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country โ 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 โ or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "ีีธึีตีถ ีฐีธีคีพีกีฎีซ 3-ึีค ีดีกีฝีธีพ ีฝีกีฐีดีกีถีพีกีฎ ีฏีกึีฃีซ ีฐีกีดีกีฑีกีตีถี ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีจ ีฃึีกีถึีพีธึีด ีฅีถ ีจีถีคีฐีกีถีธึึ ึ ีบีกึีฆีฅึีพีกีฎ ีจีถีฉีกึีกีฏีกึีฃีฅึีธีพ: ีีกึีฆีฅึีพีกีฎ ีจีถีฉีกึีกีฏีกึีฃีจ ีฏีซึีกีผีพีธึีด ีง ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีซ ีทึีปีกีถีกีผีธึีฉีตีธึีถีจ ีฏีกึีฃีกีพีธึีธีฒ ีดีกึีดีซีถีถีฅึีซ ีดีซีปีกีฆีฃีกีตีซีถ ีฐีกีดีกีชีธีฒีธีพีซ (IMDRF) ีกีถีคีกีด ีฅึีฏึีธึีด ีฃึีกีถึีพีกีฎ ีฏีกีด ิฑีผีธีฒีปีกีบีกีฐีธึีฉีตีกีถ ีฐีกีดีกีทีญีกึีฐีกีตีซีถ ีฏีกีฆีดีกีฏีฅึีบีธึีฉีตีกีถ ีถีกีญีกีธึีกีฏีกีพีธึีกีฎ ีขีชีทีฏีกีฏีกีถ ีกึีฟีกีคึีกีฟีฅีฝีกีฏีถีฅึีซ ีฐีกีดีกึ:" 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 ีี-502-ี; the consolidated expression is the version in force from 31.05.2026.
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)).
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
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 (acรกpite 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 epรญgrafe 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
Japan PMDA and Korea MFDS
No
Neither is named in the Resoluciรณn No. 000004 recognition list โ Japan appears there only as NIHS โ 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
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).
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 ยง9.4). 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 Tรฉcnica 77 versiรณn 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) โ e.g. US FDA, EMA, Japan PMDA, Korea MFDS โ 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 'HOMOLOGACIรN 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
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
South Korea MFDS
Yes
Product Licence satisfies D002; pairs with a KGMP certificate as QMS evidence
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
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 IXโXI) 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
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 (paziลoลกanas procedลซra) requires a copy of the EU declaration of conformity and copies of valid notified-body certificates issued under Regulation (EU) 2017/745, and no Latvian or Union instrument names a third-country approval as a basis for market access.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2023-08-23
Latvian source; translation: '9. Persons who in the territory of the Republic of Latvia start placing on the market class IIa, IIb and III medical devices shall submit to the agency a completed notification form (Annex 1) and attach a copy of the EC (EU) declaration of conformity, as well as copies of valid certificates issued by notified bodies (hereinafter - the notification procedure).' The excerpt shows that the only Latvian pre-market procedure is conditioned on EU documentation, i.e. on CE marking; the Union-side rule that a device may be placed on the market only if it complies with the Regulation is evidenced by the separately declared source res-lv-mdr (Article 5(1), Article 52(1)). No Latvian or EU instrument consulted names FDA, PMDA, MFDS or NMPA approval as a market-access basis.
Prior approval / evidence record
The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre-2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and class IIb implantable devices other than certain well-established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit because it is not a Directive certificate.
none
No Reliance Route
none
Premarket Review
No
Yes
Effective from 2023-03-20
English source. The excerpt is quoted from the amending act; the inserted text uses the defined terms of Regulation (EU) 2017/745 / 93/42/EEC / 90/385/EEC and names no third-country approval.
Prior approval / evidence record
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or โ for products originating outside the EU, USA, Canada, Australia and Japan โ 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 dรฉlivrรฉ par un organisme notifiรฉ (nom et numรฉro de l'organisme notifiรฉ doivent figurer d'une faรงon claire) ainsi que la dรฉclaration de conformitรฉ faite par le fabricant. o Certificat garantissant la sรฉcuritรฉ du dispositif dรฉlivrรฉ par l'une des autoritรฉs compรฉtentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformitรฉ aux normes libanaises dรฉlivrรฉ par l'institut de recherche industriel (IRI) le cas รฉchรฉant." 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 โ free-sale certificate (ุดูุงุฏุฉ ุจูุน ุญุฑ)
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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
Prior approval / evidence record
For products whose countries of origin are other than the European Union, the USA, Canada, Australia and Japan, the accepted conformity document is a certificate of conformity of the manufacturer's quality management system to ISO 13485, in place of a reference-authority approval certificate. This is the documentary channel through which a device carrying only a Korean MFDS or Chinese NMPA approval can be filed, together with the manufacturer's authorisation for the local distributor.
Korea MFDS; China NMPA; any other authority outside the EU, USA, Canada, Australia and Japan
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Un certificat de conformitรฉ ร la norme ISO 13485 du systรจme de gestion de la qualitรฉ du fabricant pour les produits dont les pays d'origine sont autres que l'Union Europรฉenne, USA, Canada, Australie et Japon." Translation: "A certificate of conformity to the ISO 13485 standard for the manufacturer's quality management system, for products whose countries of origin are other than the European Union, USA, Canada, Australia and Japan."
Prior approval / evidence record
A Korean MFDS, Chinese NMPA or other approval from outside the GHTF reference set is named in neither the closed five-jurisdiction conformity list nor the GHTF conformity requirement, and it opens no abridged or recognition route. The procedure instead provides a distinct evaluation track for medical devices that have no approval obtained from one of the regulatory authorities of the GHTF countries, so such a device is assessed on its own dossier rather than through reliance.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Evaluation des dispositifs mรฉdicaux qui n'ont pas d'approbation obtenue de l'une des autoritรฉs rรฉglementaires des pays de la GHTF." Translation: "Evaluation of medical devices that do not have an approval obtained from one of the regulatory authorities of the GHTF countries." This is the procedure's own separate step for devices lacking a GHTF-authority approval; read with section 6.3 provision 24, whose list of jurisdictions is closed.
Prior approval / evidence record
In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) โ 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 โ hence source-backed-partial. OCR original: "ุฅุถุงูุฉ ุงูู ุงูู ุณุชูุฏุงุช ุงูู ุทููุจุฉ ูู ุงูู ุงุฏุฉ ุงูุณุงุฏุณุฉ ู ู ุงููุฑุงุฑ ุฑูู 1/455 ุชุงุฑูุฎ 2013/4/16ุ ูุฑูู ุจุทูุจ ุงูุชุณุฌูู ุดูุงุฏุฉ ุจูุน ุญุฑ Free sale certificate ุฃู certificate for foreign government ุตุงุฏุฑุฉ ุนู ุงุญุฏู ุงูุฏูู ุงูู ูุชู ูุฉ ุงูู ู ุฌู ูุนุฉ IMDRF (International Medical Devices Regulators Forum) ุงู ุงููุง ุชุจุงุน ูู ูุงุญุฏุฉ ู ู ูุฐู ุงูุฏูู ู ูู ุง ูุงู ู ูุดุคูุง." 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 (ุงูู ุงุฏุฉ ุงูุฑุงุจุนุฉ, Article Four) is legible in the OCR.
Prior approval / evidence record
Korea MFDS, China NMPA and other non-reference approvals, and the manufacturer's ISO 13485 certificate as the documentary route for goods from other origins
No
Not accepted as a reference authorisation: Decision 455/1 Art. Six lists the European Union, the United States, Switzerland, Australia, Canada and Japan, and Decision 1506/1 Art. Four the GHTF/IMDRF group, but neither names Korea or China. A device made in or imported from a country outside that list follows the Industrial Research Institute's certificate against Lebanese or international reference specifications, with the manufacturer's ISO 13485 certificate accepted as evidence in the service records for sterile instruments and reagents โ a documentary route that carries no recognition and shortens no period.
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-09-16
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 โ Regulation (EU) 2017/746 (IVDR) for IVDs โ 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
Vรญa regulatoria abreviada โ 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 โ 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 ยท planning ranges remain estimates ยท reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 โ 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 ยท planning ranges remain estimates ยท reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 โ 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 ยท planning ranges remain estimates ยท 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 trรกmite 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
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 ยง3.6 permits the foreign risk grade to be considered, and Annex Two ยงยง3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate โ 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 ยท planning ranges remain estimates ยท 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 ยท planning ranges remain estimates ยท 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 ('ะะพััะฐะฟะบะฐัะฐ ะทะฐ ะพัะตะฝะฐ ะฝะฐ ัะพะพะฑัะฐะทะฝะพััะฐ ะฝะฐ ะผะตะดะธัะธะฝัะบะธัะต ััะตะดััะฒะฐ ัะต ะฒััะธ: โฆ ะธะปะธ โฆ'). 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.
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 Nยฐ 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 Nยฐ 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 Nยฐ 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 'Artรญculo 129') sets the resolution in force from 30 June 2025.
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 Resoluciรณn DINAVISA Nยฐ 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference ยท planning ranges remain estimates ยท 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 โ but every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos mรฉdicos, 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 Nยฐ 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 โ the 2026 list (Resoluciรณn DINAVISA Nยฐ 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 โ 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 Resoluciรณn DINAVISA Nยฐ 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 'Nยฐ148/2024'.
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 diagnรณstico 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
Prior approval / evidence record
Paรญs 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 Resoluciรณn Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published โ the TUPA period is set by class, not by origin
Maintained reference ยท planning ranges remain estimates ยท 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
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 ยท planning ranges remain estimates ยท 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 ยง4.12.2 โ 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
Prior approval / evidence record
A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.
WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.
Prior approval / evidence record
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country โ 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 ยท planning ranges remain estimates ยท reviewed 2026-09-16
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
Nghแป ฤแปnh 98/2021/Nฤ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) โ 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 ยท planning ranges remain estimates ยท reviewed 2026-08-29
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghแป ฤแปnh 98/2021/Nฤ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) โ 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 ยท planning ranges remain estimates ยท 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: 'โexpedited evaluationโ means the express evaluation of a product application within a 90 โ 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 โ no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference ยท planning ranges remain estimates ยท 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
approval-technical-document-review
Approval โ technical-document review
MFDS approval (ํ๊ฐ)
65
65
working-days
official-verified
Government24 service record โ medical device manufacture/import approval (์๋ฃ๊ธฐ๊ธฐ์ ์กฐ(์์ )ํ๊ฐ), processing period 10 / 65 / 80 days by review type
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000494&tp_seq=
2026-08-30
6
12
months
Yes
Yes
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
No
No direct recognition
None
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
Prior approval / evidence record
geo:kor
Medical Device Single Audit Program (MDSAP)
Qms Audit Reliance
Evidence Only
Qms Audit
Yes
Yes
MFDS guideline (๋ฏผ์์ธ์๋ด์ MDSAP ์ฌ์ฌ๊ฒฐ๊ณผ ํ์ฉ ๊ฐ์ด๋๋ผ์ธ, ์๋ด์-1349-01, 2024-02-23) governs use of MDSAP audit results when MFDS performs device GMP reviews; it is evidence reuse and does not replace Korean authorisation.
Effective from 2024-02-23
Corrects baseline source (was fda.gov); substance of the baseline edge unchanged.
Prior approval / evidence record
MDSAP
Yes
Can waive on-site K-GMP audit
2-3 months
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II (2๋ฑ๊ธ)
medium
Certification (์ธ์ฆ) by the Korea Institute of Medical Device Safety Information
5
5
working-days
official-verified
Government24 service record โ medical device manufacture/import certification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )์ธ์ฆ), processing period 5 days at the Korea Institute of Medical Device Safety Information
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A06002&CappBizCD=14710000027&tp_seq=
2026-08-30
3
6
months
No
Yes
Yes
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
Regulatory reference
Korea grants manufacturing/import approval only after MFDS (Class 3-4) or an MFDS-designated technical document review body (Class 2) reviews the application and technical documents for safety and performance under Medical Devices Act Arts. 6 and 15 and the MFDS Notice on Approval, Notification and Review of Medical Devices. No provision recognises a foreign marketing approval as a basis for abridged or waived review; foreign data are accepted only as content of the technical file (e.g., clinical data), and MDSAP results are used only within the KGMP audit layer (already held).
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-korea
All device classes (1-4) and IVDs; NMPA Class I-III certificates confer no review benefit
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: ๏ฝข์๋ฃ๊ธฐ๊ธฐ๋ฒ๏ฝฃ ์ 6์กฐ์ 2ํญ ๋ฐ ๊ฐ์ ๋ฒ ์ํ๊ท์น ์ 5์กฐ์ 1ํญ, ๏ฝข์๋ฃ๊ธฐ๊ธฐ ํ๊ฐใป์ฌ์ฌใป์ ๊ณ ๋ฑ์ ๊ดํ ๊ท์ ๏ฝฃ์ ๋ฐ๋ผ ์ ์ฒญ์ฌํญ ๋ฐ ์ ์ถ ์๋ฃ๋ฅผ ์ฌ์ฌํ์ฌ ์์ ์ฑ๊ณผ ์ฑ๋ฅ์ด ์ ํฉํ ๊ฒฝ์ฐ ์๋ฃ๊ธฐ๊ธฐ๋ฅผ ํ๊ฐ ... ๋ฑ๊ธ๋ณ๋ก ์ฌ์ฌ๊ธฐ๊ด์ด ๋ค๋ฅด๋ฉฐ, 2๋ฑ๊ธ์ ์์ฝ์ฒ์ฅ์ผ๋ก๋ถํฐ ์ง์ ๋ฐ์ ๊ธฐ์ ๋ฌธ์์ฌ์ฌ๊ธฐ๊ด์ด, 3ยท4๋ฑ๊ธ์ ์์ฝ์ฒ์์ ์ฌ์ฌ
Prior approval / evidence record
NMPA and MFDS signed a Memorandum of Understanding on regulatory cooperation for drugs, medical devices and cosmetics in Beijing on 26 February 2019. The MoU sets cooperation areas and channels (high-level meetings, staff visits and training, information exchange) and does not establish any reliance, mutual recognition or abridged review of each other's device approvals. No subsequent Korea-China device reliance pilot has been announced by either regulator as of the check date.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
south-korea
Framework MoU covering drugs, medical devices and cosmetics; no product-class scope
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2019-02-26
Source passage: ใๅไฝ่ฐ ่งฃๅคๅฟๅฝใๆ็กฎไบๅๆนๆชๆฅ็ๅไฝ้ขๅๅๆนๅ๏ผๅๆ้่ฟ้ซๅฑไผๆคใไบบๅไบ่ฎฟๅๅน่ฎญใไฟกๆฏไบคๆต็ญๆนๅผ่ฟไธๆญฅๅ ๅผบๅๆนๅจ่ฏๅใๅป็ๅจๆขฐๅๅๅฆๅ็็ฎก้ขๅ็ๅไฝใ
Prior approval / evidence record
FDA 510(k)
No
No direct recognition
None
Maintained reference ยท planning ranges remain estimates ยท reviewed 2026-08-30
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Investigational medical devices for clinical trials may be manufactured or imported without product approval, certification or notification, provided they are made in facilities meeting Prime-Ministerial-Decree criteria (and the trial plan is approved).
Effective from 2026-07-01
No person may repair, sell, lease, gift or use devices lacking the approval, certification or notification required under Articles 6(2) or 15(2); an exhibition exception is delegated to the Prime Ministerial Decree.
Effective from 2026-07-01
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
An advertiser disagreeing with a deliberation result may request re-deliberation (์ฌ์ฌ์) to the self-deliberation body within 30 days of notice; a person disagreeing with the re-deliberation result may file an objection (์ด์์ ์ฒญ) with the MFDS Commissioner within 30 days of notice.
Effective from 2026-07-01
During preliminary review (์๋น์ฌ์ฌ๊ฒํ ) of an application, missing attachment items may be submitted within 5 days.
Which UDI, device listing, database, and traceability duties apply?
MFDS may build and operate an electronic information system (์๋ฃ๊ธฐ๊ธฐํตํฉ์ ๋ณด์์คํ ) that records and manages device information from approval through manufacture, import, distribution and use.
Effective from 2026-07-01
Manufacturers/importers (์ ์กฐ์ ์๋ฑ) must register the medical device standard code (์๋ฃ๊ธฐ๊ธฐ ํ์ค์ฝ๋, i.e. UDI) and device information prescribed by Prime Ministerial Decree into the integrated device information system; MFDS administrative rule ใ์๋ฃ๊ธฐ๊ธฐ ํ์ค์ฝ๋์ ํ์ ๋ฐ ๊ด๋ฆฌ์๋ นใ (๊ณ ์ ์ 2023-67ํธ) details marking and management.
Effective from 2026-07-01
Labelling duty for the standard code is Article 20 item 8. The ๊ด๋ฆฌ์๋ น page header was opened; its article body does not render on law.go.kr.
What is reportable, by whom, where, in what format, and by what deadline?
Device handlers (์๋ฃ๊ธฐ๊ธฐ์ทจ๊ธ์) who become aware of death or serious adverse effects occurring or likely to occur during device use must report immediately to the MFDS Commissioner and keep records.
Effective from 2026-07-01
Under Enforcement Rule Article 51: death or life-threatening adverse effects must be reported within 7 days, with a detailed follow-up report within 8 days of the first report; other serious outcomes (hospitalisation or extension, permanent disability/function loss, congenital anomaly, etc.) within 15 days.
Effective from 2026-07-01
Reporter wording: ๋ฒ ์ 31์กฐ์ 1ํญ์ ๋ฐ๋ผ โฆ ๋ณด๊ณ ๋ฅผ ํ๋ ค๋ ์๋.
south-korea:medical-device
south-korea
Risk classes I through IV.
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
MFDS
official-source-verified
MFDS English guidance โ medical device classification and review routes
https://www.mfds.go.kr/eng/wpge/m_39/denofile.do
2026-08-25
South Korea
south-korea
KR
๐ฐ๐ท
Ministry of Food and Drug Safety
MFDS
asia-pacific
2
4-class (I, II, III, IV)
class-i
Class I (1๋ฑ๊ธ)
low
Manufacture/import notification (์ ์กฐยท์์ ์ ๊ณ )
0
0
days
official-verified
Government24 service record โ medical device manufacture/import notification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )(๋ณ๊ฒฝ) ์ ๊ณ ), processing period ์ฆ์ / within 3 working hours
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000510&tp_seq=
2026-08-30
0
0
days
No
No
No
class-ii
Class II (2๋ฑ๊ธ)
medium
Certification (์ธ์ฆ) by the Korea Institute of Medical Device Safety Information
5
5
working-days
official-verified
Government24 service record โ medical device manufacture/import certification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )์ธ์ฆ), processing period 5 days at the Korea Institute of Medical Device Safety Information
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A06002&CappBizCD=14710000027&tp_seq=
2026-08-30
3
6
months
No
Yes
Yes
approval-no-technical-review
Approval โ no technical-document review
MFDS approval (ํ๊ฐ)
10
10
working-days
official-verified
Government24 service record โ medical device manufacture/import approval (์๋ฃ๊ธฐ๊ธฐ์ ์กฐ(์์ )ํ๊ฐ), processing period 10 / 65 / 80 days by review type
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000494&tp_seq=
2026-08-30
10
20
working-days
Yes
approval-technical-document-review
Approval โ technical-document review
MFDS approval (ํ๊ฐ)
65
65
working-days
official-verified
Government24 service record โ medical device manufacture/import approval (์๋ฃ๊ธฐ๊ธฐ์ ์กฐ(์์ )ํ๊ฐ), processing period 10 / 65 / 80 days by review type
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000494&tp_seq=
2026-08-30
6
12
months
Yes
Yes
approval-clinical-data-review
Approval โ clinical data review
MFDS approval (ํ๊ฐ)
80
80
working-days
official-verified
Government24 service record โ medical device manufacture/import approval (์๋ฃ๊ธฐ๊ธฐ์ ์กฐ(์์ )ํ๊ฐ), processing period 10 / 65 / 80 days by review type
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000494&tp_seq=
2026-08-30
10
15
months
Yes
Yes
Yes
FDA 510(k)
No
No direct recognition
None
EU CE Mark
No
No direct recognition
None
MDSAP
Yes
Can waive on-site K-GMP audit
2-3 months
Yes
Korea License Holder
Yes
Can waive on-site K-GMP audit
5 years
official-verified
Government24 service record โ medical device manufacture/import notification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )(๋ณ๊ฒฝ) ์ ๊ณ ), processing period ์ฆ์ / within 3 working hours
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000510&tp_seq=
2026-08-30
Government24 service record โ medical device manufacture/import certification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )์ธ์ฆ), processing period 5 days at the Korea Institute of Medical Device Safety Information
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A06002&CappBizCD=14710000027&tp_seq=
2026-08-30
Government24 service record โ medical device manufacture/import approval (์๋ฃ๊ธฐ๊ธฐ์ ์กฐ(์์ )ํ๊ฐ), processing period 10 / 65 / 80 days by review type
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000494&tp_seq=
2026-08-30
Government24 service record โ medical device manufacturer/importer establishment licence (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ(์์ )์ ํ๊ฐ), processing period 25 days
https://www.gov.kr/mw/AA020InfoCappView.do?HighCtgCD=A09006&CappBizCD=14700000501&tp_seq=
2026-08-30
MFDS e-Medis โ approval procedure flowcharts and processing periods (ํ๊ฐ ์ ์ฐจ)
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
2026-08-30
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by MFDS. Appoint a Korea License Holder.
1-3 months
๐
2
Application Submission
Submit complete registration dossier to MFDS including device description, risk analysis, and testing reports.
1-2 weeks
๐ค
3
Administrative Review
MFDS reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
๐
4
Technical Evaluation
In-depth technical assessment of device safety and performance. MFDS may issue questions.
0 days
โ๏ธ
5
Registration Approval
Upon successful review, MFDS issues South Korea market authorization certificate.
1-2 weeks
โ
South Korea
south-korea
KR
MFDS
158000
158000
KRW
Yes
719000
1495000
KRW
Yes
product-application-without-technical-review
Product application without technical review
KRW
158000
158000
176000
KRW 158,000โ176,000
Per application
exact-current
official-verified
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
MFDS electronic medical-device fee table
2026-08-25
product-application-with-technical-documents
Product application with technical documents
KRW
719000
719000
799000
KRW 719,000โ799,000
Per application
exact-current
official-verified
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
MFDS electronic medical-device fee table
2026-08-25
product-application-with-clinical-data
Product application with clinical data
KRW
1495000
1495000
1662000
KRW 1,495,000โ1,662,000
Per application
exact-current
official-verified
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
MFDS electronic medical-device fee table
2026-08-25
technical-document-evaluation
Separate technical-document evaluation
KRW
561000
561000
624000
KRW 561,000โ624,000
When applicable
exact-current
official-verified
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
MFDS electronic medical-device fee table
2026-08-25
clinical-technical-document-evaluation
Separate technical-document and clinical-data evaluation
KRW
1338000
1338000
1488000
KRW 1,338,000โ1,488,000
When applicable
exact-current
official-verified
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
MFDS electronic medical-device fee table
2026-08-25
manufacturing-import-business-licence
Manufacturing/import business licence application
KRW
144000
144000
160000
KRW 144,000โ160,000
Per application
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
innovative-device-approval
Innovative medical device (์ ๊ฐ๋ฐ์๋ฃ๊ธฐ๊ธฐ) approval including technical-document review
KRW
98430000
KRW 98,430,000
Per approval
Components: technical-document review KRW 55,240,000 and clinical-data review KRW 39,170,000; approval excluding technical-document review KRW 4,020,000. Pre-review fees are deductible from the approval fee when the pre-review result is adequate.
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
approval-renewal
Approval renewal
KRW
500000
500000
520000
KRW 500,000โ520,000
Per renewal
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
certification-application
Certification application
KRW
130000
130000
145000
KRW 130,000โ145,000
Per application
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
certification-renewal
Certification renewal
KRW
430000
430000
450000
KRW 430,000โ450,000
Per renewal
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
notification-application
Notification
KRW
85000
85000
96000
KRW 85,000โ96,000
Per notification
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
notification-renewal
Notification renewal
KRW
100000
KRW 100,000
Per renewal
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
change-approval-documents-clinical
Change approval - documents and clinical review
KRW
1009000
1009000
1122000
KRW 1,009,000โ1,122,000
Per application
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
change-approval-documents
Change approval - document review
KRW
551000
551000
612000
KRW 551,000โ612,000
Per application
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
change-certification
Change certification
KRW
80000
80000
98000
KRW 80,000โ98,000
Per application
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
change-notification
Change notification
KRW
38000
38000
48000
KRW 38,000โ48,000
Per notification
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
post-market-survey-review
Post-market survey result review
KRW
90000
90000
100000
KRW 90,000โ100,000
Per review
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
sales-rental-business-notification
Sales/rental business notification
KRW
8000
8000
10000
KRW 8,000โ10,000
Per notification
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
english-certificate
English certificate
KRW
21000
21000
24000
KRW 21,000โ24,000
Per certificate
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
permit-certificate-reissue
Permit/certificate reissue
KRW
2200
2200
3400
KRW 2,200โ3,400
Per reissue
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
technical-document-pre-review
Technical-document pre-review
KRW
524000
524000
583000
KRW 524,000โ583,000
Per review
Documents plus clinical review starts from KRW 1,097,000 (second column unclear in the source annex).
exact-current
official-verified
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
2026-08-25
2026-08-25
official-verified
MFDS electronic medical-device fee table
https://emedi.mfds.go.kr/msismext/emd/bif/prmProcssView.do
2026-08-25
MFDS Enforcement Rule [๋ณํ 10] fee schedule (row-level annex)
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
2026-08-25
2026-08-25
exact-current
Yes
south-korea
South Korea
high
mfds-electrical-emc-evidence
MFDS electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
Enforcement Rule annexes: [๋ณํ 3] clinical-trial management standards; [๋ณํ 4] import-establishment facility/QMS standards; [๋ณํ 5] repair-business facility/QMS standards; [๋ณํ 6] distribution quality management linked to UDI traceability; non-clinical testing facilities are designated via forms [์์ 26์2-26์4].
unresolved
rra-kc-conformity-certification-registration-interim-certification
RRA KC conformity certification/registration/interim certification
Radio Spectrum
Mandatory If Feature
Broadcasting Or Communications Equipment
candidate
safety-korea-product-safety-kc
Safety Korea product-safety KC
General Electrical Components
Mandatory If Feature
Listed Product Or Component
candidate
RRA
conformity assessment system
https://www.rra.go.kr/en/cas/intro.do
Safety Korea
product-safety certification targets
https://www.safetykorea.kr/policy/targetsSafetyCert
Korea Law
Medical Device Enforcement Rule annexes clinical trial and QMS standards
https://www.law.go.kr/LSW/lsLawLinkInfo.do?lsJoLnkSeq=1000559734
