South Korea - Partial Amendment to the Medical Device Standards

​South Korea Ministry of Food and Drug Safety (MFDS) announces partial amendment to the Medical Device Standards.

The purpose of the amendment is to align the standards for medical devices with international standards.

This is intended to improve the safety and quality levels of medical devices distributed domestically and to preemptively block factors that could harm public health.

The amendment incorporates Harmonization with International Standards (IEC, ISO) in Appendix 1 and Appendix 2 for testing criteria and methods for five types of medical devices.

- Unabsorbable Sutures

- Heat-Polymerized Denture Base Resin

- Chemically-Polymerized Denture Base Resin

- Extraoral Dental X-ray Equipment

- Intraoral Dental X-ray Equipment 

Date of entry into force:​ December 6, 2024