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

1. Reason for Amendment
   The amendment seeks to improve medical device quality management through internationally aligned product groups based on risk and manufacturing processes, simplified document submissions and a faster review system using independent audits by quality management review bodies.
2. Key Changes
   A. Revise provisions relating to the purpose of the notice (draft Article 1).
   B. Clarify GMP conformity assessment requirements for combination devices (draft Articles 2, 4 and 6).
   C. Expand medical device product groups (draft Article 4 and Annex 3).
   D. Replace joint regional-office/review-body audits with independent review-body audits (draft Annex 4).
   E. Rationalise document review submissions (draft Article 7).
   F. Clarify GMP conformity assessment procedures (draft Article 8).
3. Additional Information
   A. Legal basis: Medical Devices Act, Articles 13 and 15; Act on Nurturing the Medical Devices Industry and Supporting Innovative Medical Devices, Article 24(9).
   B. Budget: No separate measures required.
   C. Consultation: No relevant agencies.
   D. Other:
   1) Administrative notice: No. 2022-591 (27 December 2022–7 February 2023)
   2) Regulatory review: Regulatory Reform Committee (1–4 May 2023)