South Korea - Re-announcement of the Draft Amendments to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act

The Ministry of Food and Drug Safety (MFDS) has re-announced the draft amendments to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act.

​​​The amendments aim to address and improve shortcomings in the existing system related to the operation of in vitro diagnostic medical devices, with a focus on strengthening the quality and infrastructure for newly developed devices. Key updates include:

- Adjustment of fees for newly developed devices (Article 41, Appendix 3)

- Exemption of documentation for reverification of quality managers (Articles 4(1)(3), 24(2))

- Labeling of usage period after opening (Article 36(1))

- Simplification and clarification of the notification system for Class 1 devices (Article 5(2), Appendix Forms 7 & 18)