[GMP Update] Product Groups for Applications Before 13 November 2023 (February 2024).

Under Article 3(1) of the supplementary provisions to MFDS Notice No. 2023-31, certificates issued under the previous rules are interpreted in terms of the revised 64 product groups, based on the devices assessed for GMP conformity.

For applications received before the revised notice took effect, the audited devices should be checked and the relevant groups from the new 64-group classification entered on the certificate.

Product groups excluded from the audit because no production occurred are also excluded from the certificate. If those products are later manufactured or imported for sale, an additional product-group audit is required, and applicants should be informed in advance.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=6&bbsSno=1340