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Korea's only public comprehensive testing and certification organization Customer makes KTL

Customer makes KTL

Main Business

Medical Health

Review Technical Document

  • In accordance with Clause 1 of Article 7 of Enforcement Regulations of the Medical Device Act, review technical documents (2nd rated medical device)

Electronic Medical Devices Test and Evaluation

  • Overview
    • In accordance with Article 27 of Medical Device Act, test the safety and functions of medical devices.
  • Business Fields
    • Test and evaluate in accordance with “Common Standards and Specifications for
    • Electromechanical Safety of Medical Devices”
    • Test and evaluate in accordance with “Common Standards and Specifications for Electromagnetic Safety of Medical Devices”
    • Test and evaluate in accordance with “Standard Criteria of Electrical Medical Devices”
    • Test and evaluate in accordance with “Announcement of Same Products of Medical Devices”
    • Test and evaluate the performance of medical devices
    • Inspect imported and used medical devices in advance
    • Consigned test and inspect ( Consigned test for quality control of manufacturers and import companies)
    • Test and evaluate medical devices for international certifications

Medical Supplies ㆍ Dental Materials

  • Overview
    • As we are designated as an inspection agency for medical devices by Food and Drug Administration, we not only test overall medical supplies/ dental materials but also perform a variety of technical support required during product development and quality control.
  • Business Fields
    • Biological safety test
    • Evaluate functions and physical physicochemical mechanic characteristics
    • Consigned test for quality control
    • Evaluate the process validation

Quality Assessment (GMP) of Medical Devices

  • Overview
    • In accordance with Medical Device Act, assess the production of medical devices and suitability of quality control standards
  • Applicable Items
    • Manufacturing medical devices, import medical devices, and medical devices for clinical test

Operation of Information Technology Support Center for Medical Devices

  • Ministry of Food and Drugs Safety (MFDS) established an organization in 1998 within KTL in order to foster and support the medical device industry in Korea.
  • Website of Medical Devices Quality Support Center (http://www.ktlmedi.re.kr)

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