Oct 24, 2018
EMERGO SUMMARY OF KEY POINTS:
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:
Emergo analysts will provide updates on MFDS efforts to finalize its proposal as we learn them.
Additional South Korean medical device regulatory resources from Emergo by UL:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: