SOUTH KOREA: AMENDMENT TO THE MEDICAL DEVICE ENFORCEMENT RULES AND MEDICAL DEVICE STANDARDS - AUGUST/SEPTEMBER 2025
- 2025-09-24 08:47:47
The Ministry of Food and Drug Safety (MFDS) has announced amendments to both the Enforcement Rules of the Medical Device Act and the Medical Device Standards. The revisions, implemented between April and August 2025, included higher fees for innovative medical device reviews, exemptions from documentation requirements, stricter administrative sanctions, and the establishment of long-term follow-up requirements. In addition, amendments to the Medical Device Standards have been finalized and are scheduled to take effect in July 2026, introducing new standards and aligning existing ones with international norms.
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