Aiming to harmonize the Korean Good Manufacturing Practice (KGMP) with the requirements of the ISO 13485:2016: 2016 Standard, the South Korean Ministry of Food and Drug Safety (MFDS) issued on October 1st, 2018 the Notification No. 2018 – 409 “Manufacture and Quality Control Standards for Medical Devices (Food and Drug Administration Notice 2016-156)”.
Through the alignment of KGMPs with the harmonized Standard for medical device quality management systems, ISO 13485:2016, the MFDS intends to improve the quality control process and establish more stringent and clearer criteria for audits.
Furthermore, this transition to ISO 13485:2016: 2016 requirements could open the way for the inclusion of South Korea in the MDSAP Program.
This Notification is currently under public consultation and the MFDS will accept any comments from the stakeholders on the proposed measures until the end of November 2018.