Regulatory Updates.
[GMP Update] Remaining Validity for Batch Periodic Applications
MFDS stated that the interpretation manual would recommend batch periodic audit applications for sites with no more than one year remaining on their certificates, reflecting the three-year audit cycle. Because batch applications are intended to reduce the burden on companies…
Revision of Korea's Medical Device GMP Operating Guidance
The operating guidance for Korea's medical device manufacturing and quality management standards (GMP) has been revised. The guidance aims to ensure accurate, consistent and transparent implementation of the medical device GMP standards by the personnel responsible.
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…
Revised KGMP Requirements (Notice No. 2023-31, 12 May 2023)
[MFDS] Partial amendment to the medical device GMP standards (Notice No. 2023-31, 12 May 2023) MFDS Notice No. 2023-31