The Ministry of Food and Drug Safety (MFDS) has updated its Medical Device Standards as of December 6, aiming to enhance the safety and quality of domestic medical devices while aligning them with international standards like IEC and ISO.
✅ Key Updates
The revisions focus on improving testing criteria and methods for five key items, including dental materials with high export potential:
- Non-absorbable sutures (Class III): For tissue suturing
- Heat-polymerized denture base resin (Class II): Heat-based denture materials
- Chemical-polymerized denture base resin (Class II): Chemically reactive denture materials
- Extraoral dental X-ray equipment (Class II)
- Intraoral dental X-ray equipment (Class II)
Expected Impact
The MFDS expects these changes to boost the global competitiveness of Korean medical devices and has reaffirmed its commitment to continuously harmonizing domestic standards with global norms.
Stay tuned for more updates on Korea’s medical device certification!
