South Korea – South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016


  • South Korea’s MFDS to harmonize Korea Good Manufacturing Practice (KGMP) quality system regulations to ISO 13485:2016.
  • Aligning KGMP to ISO 13485 would pave the way for South Korean participation in the Medical Device Single Audit Program (MDSAP).
  • MFDS is accepting industry feedback on the plan through November 2018.

The South Korean Ministry of Food and Drug Safety (MFDS) has issued draft plans to align Korea Good Manufacturing Practice (KGMP) more closely to the ISO 13485:2016 medical device quality system standard.

MFDS is seeking comment from industry on its draft plan (link in Korean) until November 29, 2018. Harmonizing KGMP requirements with the latest edition of ISO 13485 would improve quality control and establish more rigorous criteria for desktop audits for quality system compliance, states MFDS. According to Emergo by UL consultants in Seoul, transitioning from KGMP to ISO 13485:2016 would also facilitate eventual South Korean participation in the international Medical Device Single Audit Program (MDSAP).

How harmonization with ISO 13485 would impact QMS compliance in South Korea

MFDS identifies several compliance issues that would result from aligning KGMP requirements with ISO 13485:2016…