[MDREX NEWSLETTER] 2025 MFDS Medical Device Policy Briefing 2025 MFDS Medical Device Policy Briefing Presentation |
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On March 20, 2025, the Ministry of Food and Drug Safety (hereinafter “MFDS”) held the 2025 Medical Device Policy Briefing. MFDS conducts this annual policy briefing in accordance with Article 13 of the Administrative Procedures Act, which mandates prior notification to the public when implementing measures, notifications, or system changes that significantly impact the rights and obligations of the public. Accordingly, MFDS presented both the regulatory improvements implemented in 2024 and the newly planned policy changes for 2025. The following is a summary of key regulatory changes to be closely monitored in 2025, as well as new policies taking effect this year based on the 2024 regulatory improvements. |
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1) KGMP Audits for Class III Medical Devices to be Independently Reviewed by Public-Private Reviewing Agencies
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Previously, Class III and IV medical devices were subject to joint audits conducted by the MFDS Regional Offices and public-private reviewing agencies. However, in 2025, MFDS announced a regulatory revision so that public-private reviewing agencies will independently review Class III medical devices. |
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2) On-Site Audits Exempted for Some KGMP Regular Audits (Effective May 1, 2025) |
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MFDS announced that overseas manufacturing sites recognized as “Outstanding Manufacturing Facility” will be eligible for document-based reviews instead of on-site inspections. However, one of the criteria for Outstanding Manufacturing Facility recognition includes “having undergone an on-site inspection during the previous regular audit”; therefore, once designated as an Outstanding Manufacturing Facility, the on-site inspection cycle will be extended from three years to six years. |
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According to the Attached Table 1 of Standards of Medical Device Good Manufacturing Practices, "Outstanding Manufacturing Facility" refers to a manufacturing facility that meets all of the following criteria:
a. Not classified as a high-risk manufacturing facility (in the part three years, the applicant manufacturing facility received unqualified GMP assessment, applicant product group received unqualified quality assessment, or applicant product has been subject to a mandatory recall, suspension of use or suspension of manufacturing).
b. No history of administrative sanctions under the Medical Devices Act in the past three years.
c. The most recent regular inspection was conducted on-site, and the results of the on-site inspection were deemed satisfactory.
d. Possesses a valid quality management system certification issued by the regulatory authority, and can provide evidence that all corrective actions for non-conformities identified in the certification have been completed (applicable to imported medical devices). |
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3) Infrastructure and Guideline Development for the Implementation of the Digital Medical Products Act |
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· Development of guidelines on clinical trial evaluation, special regulatory exemptions (e.g., waiver of submission requirements for registered API components, etc.), manufacturing and quality management standards (KGMP), security guidelines, labeling requirements, and advertising regulations for digital medical products.
· Development of performance certification guidelines for digital medical/health support devices.
· Establishment of technical support measures for compliance with cybersecurity guidelines on electronic intrusion prevention (e.g., Software Bill of Materials [SBOM], legacy system management, etc.) |
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4) Preemptive Approval and Review Guidelines for Innovative Advanced Technology-Based Medical Devices |
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Clarifications provided for robotic surgery systems (clinical trials requirements), sustained-release drug delivery medical devices (clinical efficacy evaluation parameters and animal study data requirements), dermal fillers (specification of approval criteria), coated orthopedic medical devices (mandatory performance testing parameters refined), gene editing technology-based products (performance evaluation criteria), generative AI medical devices (establishment of safety, performance, and clinical evaluation methodologies), etc. |
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5) Introduction of Clinical Evaluation Reports (CERs) |
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MFDS announced that, in demonstrating safety and efficacy at the time of approval, applicants may use conventional clinical trial data or submit a Clinical Evaluation Report (CER), which is required under the Medical Device Regulation (MDR). Because a CER is a report that takes into account clinical trial data, systematic literature reviews, real-world clinical experience, etc., products approved with a CER submission may become eligible for a deferred assessment of the New Health Technology Assessment (nHTA) with a future amendment to the relevant Ministry of Health and Welfare regulations. |
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These regulatory changes, including new approval pathways and evaluation guidelines, will significantly impact the market entry and renewal strategies of medical device companies. Continuous monitoring of these regulatory developments is essential for businesses in the industry.
If you require assistance with strategic planning or regulatory support
for medical device approvals,
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