Korea MFDS Updates Medical Device Standards to Meet Global Standards

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Dental X-Ray Equipment Revised to Meet International Standards
Dental X-Ray Equipment Revised to Meet International Standards

The Ministry of Food and Drug Safety (MFDS) has announced significant updates to its Medical Device Standards, effective December 6. These updates aim to improve the safety and quality of medical devices produced in Korea and bring them in line with international benchmarks such as IEC and ISO.


Highlights of the Revision

The updated standards focus on enhancing testing methods and criteria for five major items, including export-oriented dental materials:

  • Non-absorbable sutures (Class III): Used for tissue suturing
  • Heat-polymerized denture base resin (Class II): Materials designed for denture fabrication using heat
  • Chemical-polymerized denture base resin (Class II): Materials for denture fabrication through chemical reactions
  • Extraoral dental X-ray equipment (Class II)
  • Intraoral dental X-ray equipment (Class II)


Anticipated Benefits

With these revisions, the MFDS aims to strengthen the global competitiveness of Korean medical devices. The agency also emphasized its dedication to aligning domestic standards with international requirements through ongoing improvements.


Stay connected for more insights into Korea's medical device certification!


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Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com


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