Key Changes to MFDS Medical Device Rules and Standards (2025–2026)

1. Amendments to Enforcement Rules (Effective April 1, 2025)

• Fee Adjustments for Innovative Medical Devices
  • Technical document review & approval:
    Previous: KRW 1,495,000 (electronic) / KRW 1,662,000 (paper)
    Revised: KRW 98,430,000
  • Pre-review of technical documents:
    Previous: KRW 524,000 (electronic) / KRW 583,000 (paper)
    Revised: KRW 55,240,000
• SME Fee Reduction: Up to 50% reduction for small and medium enterprises.
• Document Waivers: If a Quality Manager’s qualification has been verified through the Medical Device Integrated Information System, submission of related documents may be exempted.

 

2. Amendments to Enforcement Rules (Effective July 24, 2025)

• Administrative Sanctions for Manufacturers and Importers

If manufacturers or importers obtain permits, certifications, or approvals through false or fraudulent means, MFDS may cancel the approval or order closure of the business site.

 

3. Amendments to Enforcement Rules (Effective August 1, 2025)

• Designation of Long-Term Follow-Up Devices

• MFDS may designate certain devices for long-term follow-up when adverse events occur annually, when serious risks such as death or irreversible harm are possible after implantation, or under other comparable conditions.
• Designations will be officially announced by MFDS.

• Real-World Evidence (RWE) Submission

• The Korea Medical Device Safety Information Center may recruit physicians and dentists to participate in follow-up studies.
• Required data include patient identifiers, device name and lot number, date and details of use, adverse event information, and institution details.
• Data must be submitted through MFDS-designated software.

• Analysis and Reporting

• RWE must be analyzed and evaluated semiannually, with results reported to MFDS by the end of the following month.
• Immediate reporting is required if significant changes in adverse event frequency are detected, if events meet specified severity criteria, or if MFDS requests urgent evaluation.
• Further details will be specified by MFDS through official notices.

 

4. Amendments to Medical Device Standards (Effective July 4, 2026)

• New Standards Established (6 products)

• Examples: condensation-type dental silicone impression materials, high-intensity focused ultrasound surgical systems.
• Categories: Dental materials (1), equipment/machinery (4), Class I devices (1).

• International Harmonization (17 products)

• Examples: anesthesia machines, incubators.
• Categories: Dental materials (3), equipment/machinery (13), Class I devices (1).

Purpose: To secure the safety and performance of medical devices distributed in Korea and align with ISO/IEC standards.

 

Conclusion

The MFDS has partially amended the Enforcement Rules of the Medical Device Act during 2025, and the revised Medical Device Standards will take effect from July 4, 2026. These regulatory updates reflect strengthened oversight of medical device safety and harmonization with international standards.

 

Get in touch with us today to see how we can help you navigate these MFDS regulatory changes and ensure smooth market access in South Korea!

 

Reference

1. Enforcement Rules of the Medical Device Act (법령 > 제정·개정문 - 의료기기법 시행규칙 | 국가법령정보센터)
2. Notices on Amendments and Revisions – Details (식품의약품안전처>법령/자료>법령정보>제개정고시등 - 상세보기 | 식품의약품안전처)