ARTICLES
Newsletter.
Regulatory developments in medical devices and IVDs,
market updates and insights from BCG
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…
PATH TO SUCCESSNeed expert support?
Contact Us