GMP Certificate Application Guide: Manufacturing Site Information.
Medical device manufacturers/importers must obtain recognition of compliance with Korean manufacturing and quality management standards before sale or use. Regional MFDS offices and review bodies issue GMP certificates following a conformity decision.
MFDS determines the manufacturing-site name and address on the certificate by reviewing QMS relationships, contractual arrangements and the manufacturing flow submitted with the application. These details inform selection of on-site audit locations and whether initial or site-relocation audits are required.
The guide presents examples to help applicants identify the relevant manufacturing arrangements, such as a single manufacturer or a manufacturing sponsor–manufacturer relationship.
The guide covers site information in GMP certificate applications and examples of issued certificates. For wider explanations of GMP requirements, consult the Comprehensive Medical Device GMP Interpretation Manual.