[GMP Update] Certificate Validity for Temporarily Deferred On-Site Audits.

MFDS advised that sites whose on-site audits are temporarily deferred should receive certificates with the statutory three-year validity period. It stated that this approach was being implemented immediately, with revisions to the GMP operating guidance and interpretation manual planned.

Manufacturers/importers must apply to the review body within 10 days after the situation affecting the site's location ends, and the audit must be completed within 90 days after submission.

For each import shipment, inventory records, import declarations, the device specification document showing in-house quality testing specifications, and corresponding test reports must be submitted for post-market oversight.

Previously issued temporary on-site audit documents are excluded from periodic audit requirements as a group.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=16&bbsSno=1339