[GMP Update] Certificate Entries for Medical Device Sets.

For a device supplied as a set, MFDS advised listing only the final packaging site, which bears legal responsibility, on the front of the GMP certificate. Other manufacturing sites are listed on the reverse.

MFDS stated that guidance already requires documents from each manufacturing site and assessment of each applicable product group for devices supplied as a set.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=4&bbsSno=1341