On March 11, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a public notice regarding the partial revision of the standards for medical device manufacturing and quality control. This revision aims to allow domestic export companies to undergo both KGMP and Medical Device Single Audit Program (MDSAP) simultaneously.
The revision provides a legal basis for combining the ‘MDSAP Quality Management System Compliance Audit’ with conformity assessments (KGMP), thus improving the convenience for businesses. The goal is to rationally improve the medical device conformity assessment and other related review systems.
The main revisions are as follows:
* Establishment of a legal basis to combine audit of KGMP and MDSAP
- The conformity assessment under the MDSAP for the Quality Management System (QMS) can now be combined with the conformity assessments based on KGMP standards.
- Korean companies wishing to export medical devices previously had to undergo separate KGMP conformity assessments and MDSAP assessments recognized by the export countries. With this revision, companies can now apply for combined audits for both domestic GMP conformity assessments with the same quality management audit organization. This will allow companies to undergo both assessments during the same period, reducing the burden on the industry.
- MDSAP audits can be conducted by the following two organizations: TUV SUD Korea Ltd. and TUV Rheinland Korea Ltd.
Please refer to the attached document below.
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