Partial Revision of the Enforcement Rules of the In Vitro Diagnostic Medical Device Act by the Korea MFDS

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In Vitro Diagnostic Medical Devices
In Vitro Diagnostic Medical Devices

The Ministry of Food and Drug Safety (MFDS) has announced a partial revision to the Enforcement Rules of the In Vitro Diagnostic Medical Device Act.

Public opinions will be accepted until February 7, 2024.


- Clarification of Exemptions for Manufacturing and Importation Permits of In Vitro Diagnostic Medical Devices


- Reinforcement of Corrective Orders and Administrative Sanctions for In Vitro Diagnostic Medical Device Manufacturers and Importers Not Meeting Facility Standards


If you have any inquiries regarding the certification of medical devices in Korea, please contact GCA KOREA.



👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com

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