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Regulatory developments in medical devices and IVDs,
market updates and insights from BCG
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
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