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

EMERGO SUMMARY OF KEY POINTS:

• 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:

• Multiple actual manufacturers operating under a single legal manufacturer would be subject to on-site initial audits by either MFDS or third-party auditors;
• Definitions and criteria would be specified for hazardous manufacturing facilities and nonconformities identified in audits and inspections;
• More explicit and stringent requirements for desktop audits of items including organizational charts, quality master lists, declarations of conformity and compliance checklists;
• Audit processes would be updated to clarify document processes for suspensions, Class II devices and audits conducted by third parties, as well as number of working days;
• Definitions would be updated to remove or revise unused, duplicate and unclear terms;
• KGMP application forms would undergo updating;
• A numbering system would be established for Class I KGMP export-only certificates as well as reissues of these certificates.

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:

• South Korean MFDS medical device registration consulting
• Korea Good Manufacturing Practice (KGMP) quality system support
• Korea License Holder (KLH) in-country representation
• Whitepaper: Medical device registration in South Korea
• Regulatory process chart: MFDS approval for medical devices