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Medical Devices

Review & Approval

Background

  • To develop a future-oriented review and approval system, to reinforce the expertise for review of new medical devices and to promptly and actively respond to changes in market environments in order to ensure public health, and the safety and development of the medical device industry
  • To develop technologies for safety and performance assessment of medical devices and to ensure expertise and reliability in review and approval process
  • To ensure continuous scientific development and advancement of standards and specifications for medical devices

Key activities

  • Government-wide cooperation to promote the rapid commercialization of new medical devices based on new convergence technologies
  • Operation of a Medical Device Communication Forum (MDCF)
  • Reinforced international cooperation and regulatory harmonization
  • Advanced review and approval system
  • Customized training services and rapid approval process
  • Offering of information on safety of medical devices under consideration of consumers' needs
  • Advancement of review and approval system through harmonization of regulatory requirements for in vitro diagnostic devices
  • Development of guidelines for safety and performance assessment of new medical devices
  • Development of guidelines for the development and review/approval of medical devices
  • Development of guidelines on performance

Medical Device Brochure

  • Your Vision, Our Future, Korean Medical Device  Download
R&D
Technological development for safety and performance assessment of medical devices, development of expertise and reliability in review and approval processes
Reinforcement of industrial competitiveness through improvement of the approval/authorization process and advancement of the medical device regulatory system through investigation and analysis of systems in advanced countries
1 Advancement of the safety control system
  • Studies on harmonization of regulatory requirements and safety polices covering the whole lifecycle from development, through commercialization, to post-approval safety control, to ensure prompt response to international trends
2 Scientific reviews and assessments
  • Development of test methods, specifications and review/approval guidelines to ensure safety control of medical devices and advanced regulatory science
3 Assessment and Development of medical devices for future medical environments
  • Studies to support mid/long-term government-wide plan on development of medical devices and promotion of medical device industry
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