On December 19, 2023, the Ministry of Food and Drug Safety (MFDS) has revised the “Standards of Medical Device Good Manufacturing Practices (Notice of the MFDS)” and announced that those with an MDSAP certificate will be exempted from on-site GMP inspections.

Medical Device Single Audit program (MDSAP) refers to a system in which five member countries including USA and Japan mutually recognize review results by Audit Organizations (AO). AO is designated and operated by member countries and reviews quality management conformity of medical devices.

MFDS has recognized MDSAP conformity certificates only as a reference in the KGMP review process. However, through this revision, MDSAP certificate will be recognized as evidence for exemption from on-site initial/changed/additional KGMP inspections. Still, GMP inspection for renewal in every three years will be conducted on-site even though the manufacturer holds a MDSAP certificate, which means having an MDSAP conformity certificate does not mean that all on-site screenings are exempt.

In order for a MDSAP holder to be exempted from the on-site inspection, the following documents are required for KGMP application, so they should be provided to local Korean representative.

1. Copy of MDSAP certificate of conformity and review report.
2. Device Master Record of the product with highest classification at the site
3. QMS documents that comply with Korean law/regulations on medical device such as:

1. Quality Manual
2. Record Management System
3. Documents that define QMR’s work scope, etc.
4. Procedure for management of medical devices subject to tracking (if applicable)
5. Procedures related to reporting adverse event announcement.

4. Document that can confirm the correlation between the product with MDSAP conformity certification and product subject to KGMP audit.

If have any questions about the above changes on regulation regarding KGMP review as above, please contact MDREX (pro@mdrex.co.kr) at any time.

Thank you.