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

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): In Vitro Diagnostic

5.

Details of notified document(s) (title, number of pages and languages, means of access): Proposed amendment to the "Regulations on In Vitro Diagnostic Medical Device Approval/Report/Review, etc."; (18 page(s), in Korean)

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

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 "Regulations on In Vitro Diagnostic Medical Device Approval/Report/Review, etc." as follows:

- Establishment of regulatory basis for the submission of usability data included in the approval and review dossier for self-testing in vitro diagnostic medical devices, and other relevant requirements.

7.

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

8.

Relevant documents:

MFDS NOTIFICATION No. 2025-387, 4 September 2025

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: 4 November 2025

[X] 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