South Korea - Notice of Partial Amendment to the Standards for Medical Device Manufacturing and Quality Management
Business description
The Ministry of Food and Drug Safety (MFDS) announced on June 12, 2026 a proposed partial amendment to the Standards for Medical Device Manufacturing and Quality Management. The amendment follows the revision of the Medical Device Act (Act No. 21263, December 30, 2025), which established the legal basis for conformity assessment reviews related to medical device Good Manufacturing Practice (GMP). Its main purpose is to improve the usability of the regulation by retaining only the provisions on conformity assessment reviews used in manufacturing and quality control, while transferring matters such as the designation and management of quality management review institutions and designation and management of training institutions for quality managers to a newly established separate notification, including attached forms.
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