[GMP Update] Determining Certificate Validity Dates (February 2024).

With online GMP application and processing implemented, MFDS advised establishing a consistent certificate issue-date rule for each quality management review body.

Previously, audit results were reported to the regional MFDS office for both independent and joint audits, and the reporting date was used as the certificate issue date.

For joint audits, Article 8(7) of the medical device GMP standards requires the review body's head to submit a report to the regional office. MFDS advised using the regional office's final approval date as the certificate issue date.

For an independent audit, the proviso to Article 8(7) allows the review body's audit report approval date to remain the certificate issue date.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=8&bbsSno=1340