Key services of KTC

Testing and inspection
  1. 1. Electrical and Electronic
  2. 2. Meters
  3. 3. Chemical and environment
  4. 4. Bio and medical
  5. 5. Information and Communications
  6. 6. Energy
  7. 7. Renewable
  8. 8. Specialized Public Procurement
  9. 9. Verification
  10. 10. Calibration
  11. 11. International standard
  12. 12. Software and security test
  13. 13. Inspection of the playground facilities for children
  14. 14. Safety inspection of amusement facility
Certification and assessment
  1. 1. KC Product Certification
  2. 2. KS Product Certification
  3. 3. Q-mark
  4. 4. EMF certification
  5. 5. V-check product certification marks
  6. 6. Performance Certification
  7. 7. Medical device assessment
  8. 8. International standard certification새창
  9. 9. View the GCC certification status
R&D
  1. 1. Technical regulations impact evaluation
  2. 2. Intellectual Property evaluation support (Patent technical evaluation)
  3. 3. Standard Technology Development Type
  4. 4. SME Technological Innovation R&D Program
  5. 5. New-Product Development Support with an Off-Take Arrangement
  6. 6. The 4th Industries and Smart City

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Key services of KTC

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The approval process for medical devices

Introduction to the medical device testing service

We have been designated as a testing agency for medical devices covering the medical device test, technical document review, and qualitative compliance tests. With this, we are providing test services and qualitative compliance test services. We promise that we will help our customers with our best efforts for true customer satisfaction over the entire process of medical device approval.

The responsible teams

Medical Suppliers Test Medical Bio Team (031-428-3855)
Medical Device Testing Electronic Medical Center (031-428-5651)
GMP Quality Test GMP Test Team (031-428-8430)
Technical document review
(Grade 2 Medical Device)
Medical Test Team (031-428-3725)
Medical Device R&D and Services Electronic Medical Center (031-428-5634)

The approval process for medical devices

The approval process for medical devices image

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Related laws and regulations

01 The laws related to the GMP evaluations of medical devices Download

Visit the website of the responsible department

Click the button below to jump to the main webpage of the responsible department, where you can find the contact information of the officers in charge.

Visit the website of the responsible department

The approval process for medical devices Jump to the Electronic Medical Center.

최종수정일: 2020-11-03 오후 7:54:27