MFDS Designates 3 New Self-Testing IVDs: New Market Access in Korea

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The Ministry of Food and Drug Safety (MFDS) announced its plan to newly designate three items as self-testing in vitro diagnostic medical devices (IVDs), aiming to enhance rapid test accessibility during infectious disease outbreaks and to promote early detection and appropriate medical response for diseases that are often avoided due to testing reluctance. (Announcement No. 2026-159)

 


Public opinions on the proposed amendment will be accepted until April 14, 2026.

 

The newly added self-testing IVD items are as follows.

  • IVD reagents for self testing of Influenza virus or SARS-CoV-2 using immunological method
  • IVD reagents for self testing of sexually transmitted infections using immunological method
  • IVD reagents for self testing of drugs of abuse

GCA Korea provides expert support for global companies navigating Korea’s regulatory requirements, including KC Certification.

Our expertise covers KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), and MFDS (Korean Medical Devices).

Contact ⬇
Tel. +82-31-360-8180
E-mail: forest.lee@gca-kr.com


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