Korean MFDS Amends the Medical Device Act Enforcement Rules

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On August 7, the Ministry of Food and Drug Safety (MFDS) made significant revisions to the Medical Device Act Enforcement Rules. These updates, effective from August 7, 2024, bring several key changes.


🔹 All Class 1 medical devices will be unified under a notification system.

🔹 Exemptions from clinical trial plan approvals will be expanded.

🔹 Participation criteria for non-clinical trial institutions will be established.

🔹 Standards for Braille and markings for the visually and hearing impaired will be established.


This revision is expected to expedite entry into the medical device market and enhance the usability of medical devices for vulnerable populations.


🌐 Looking for Korean Medical Device Certification?

For all your Korean medical device certification needs, contact GCA KOREA.



👉 Contact GCA

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


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