The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to the Regulations on Good Manufacturing Practice (GMP) for Medical Devices on March 11 to expedite GMP conformity assessment audits for medical device manufacturers. Public comments will be accepted until March 31.
Key Aspects of the Amendment
- Introduction of a combined audit system, allowing companies to undergo both domestic GMP conformity assessment and the Medical Device Single Audit Program (MDSAP) audit simultaneously
- Establishing a legal basis for delegating GMP audits of Class 3 manufactured and imported medical devices to private organizations
- Refining GMP audit regulations for software-based medical devices in accordance with the Digital Medical Products Act
With these changes, domestic companies seeking to export medical devices will no longer need to undergo a separate MDSAP audit, as they can complete both audits at once through the combined system. Additionally, private quality management audit bodies will independently conduct GMP audits for Class 3 medical devices.
MFDS plans to continuously improve the medical device GMP system to support the introduction of innovative products incorporating advanced technology, expand patient treatment opportunities, and support the export of domestic medical devices.
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