Korea’s Ministry of Food and Drug Safety (MFDS) has revised its regulation on post-market surveillance of medical devices by clarifying the criteria and required documentation for exempting rare disease devices with overseas use experience from Korea’s surveillance requirement. Post-market surveillance confirms the safety and effectiveness of rare and newly developed devices for a period of four to seven years after sale in Korea. The ministry previously granted exemptions on a case-by-case basis without defined standards for what counted as overseas use experience or what evidence companies needed to submit. The revision now defines the scope of qualifying overseas use and specifies acceptable submission materials, including overseas clinical data. The clarified criteria are expected to reduce the administrative burden on industry, support stable supply of rare medical devices in Korea, and improve treatment access for patients with rare diseases.
Korea’s MFDS has also issued three new guidance measures under its Digital Medical Products Act. Under guidelines released on September 16, manufacturers can have key components, such as an AI algorithm or biosensor, evaluated in advance. They can then use those cleared components in a later application for the full system. The MFDS expects this to lower development costs and speed market entry. In addition, on September 10, the agency updated its clinical trial protocol guidance for digital products covering seven indications, including depression, ADHD and mild cognitive impairment. It also published a GMP Q&A explaining audit procedures. The Q&A says companies that already hold medical device GMP certification will need a separate audit for digital products, though a streamlined route may apply in some cases.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.