Korea MFDS Plans for Harmonization with Latest ISO 13485 & MDSAP

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the latest International Standard (ISO 13485:2016), will lay the foundations for Korea to prepare to join the Medical Device Single Audit Program (MDSAP). The draft plan on the work items was shared with the industry. These will bolster MFDS' qualifications and capabilities as professional and systematic auditors and further the international coordination of quality systems for medical devices.

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

- Food & Drugs Authority of USA

- Therapeutic Goods Administration of Australia

- Brazil’s Agência Nacional de Vigilância Sanitária

- Health Canada

- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers

For more information on the original draft plan from Korea MFDS, check out the following link:

- MFDS draft.

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