G/TBT/N/KOR/1348

7 April 2026

(26-2694)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: REPUBLIC OF KOREA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Ministry of Food and Drug Safety (MFDS)

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Medical Devices

5.

Details of notified document(s) (title, number of pages and languages, means of access): Proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices"; (13 page(s), in Korean)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/KOR/26_01879_00_x.pdf

Documents are available from the Ministry of Food and Drug Safety (MFDS) website: www.mfds.go.kr

International Cooperation Office, Ministry of Food and Drug Safety

187 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do, 28159 Republic of Korea

Tel: (+82) 43 719-1564, Fax: (+82) 43-719-1550, Email: intmfds@korea.kr

6.

Description of content: The Ministry of Food and Drug Safety (MFDS) is amending the "Regulation on the Permission, Notification, Review, etc of Medical Devices" as follows:

1) Class 1 medical devices approved/certified/notified prior to changes in approval/certification/notification may be manufactured or imported for 6 months from the date of the change approval, etc.

2) Expansion of the scope of real-world evidence for medical devices as clinical investigation documents

3) Abolition of the notarization for translations of documents in foreign languages other than English

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

Relevant documents:

MFDS NOTIFICATION No. 2026-167, 30 March 2026

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 27 April 2026 (20 days from notification)

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Korea WTO TBT Enquiry Point

Technical Regulatory Policy Division

Korean Agency for Technology and Standards (KATS)

93 Isu-ro Maengdong-myeon Eumseong-gun

Chungchungbuk-do

27737

Tel: +(82) 43 870 5315

Fax: +(82) 43 870 5682

Email: tbt@korea.kr

Website: https://www.knowtbt.kr

Agricultural products:

Quarantine Policy Division

Ministry of Agriculture, Food and Rural Affairs (MAFRA)

94, Dasom 2-ro, Sejong-si

Sejong-si

Sejong-si 339-012

Tel: +(82 44) 201-2080

Fax: +(82 44) 868-0449

Email: wtoagri@korea.kr