GMP Standards Notification
The MFDS GMP Standards Notification (์๋ฃ๊ธฐ๊ธฐ ์ ์กฐ ๋ฐ ํ์ง๊ด๋ฆฌ ๊ธฐ์ค) defines the detailed requirements of the Korean Good Manufacturing Practice (KGMP) system, largely aligned with ISO 13485:2016.
Key chaptersโ
- Management responsibility
- Resource management
- Product realisation (design, development, production)
- Measurement, analysis, and improvement (CAPA, internal audit)
- Korean-specific documentation requirements and GMP certificate application
IVD-specific GMPโ
A separate chapter (or separate notification under the IVD Act) covers IVD-specific GMP requirements.