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Documentary review for medical devices

Overview

Performs the technical document review for medical devices in accordance with Article 9 of the Enforcement Rules of Medical Device Act.

Scope of program

  • Documentary review for medical devices
  • The review of the changes in the technical documents of medical devices

The scope and items subject to the assessment

1. The scope of the assessment
The reviews shall, in principle, conducted by manufacturers, categories, or items (model names). And the products which are added after the submission of the review request are excluded. However, it is allowed to submit one review request to cover the items that belong to the same product group.
2. The items subject to a change review
The medical devices are requiring a permit or certification for a change that does not impact the safety or effectiveness as per the change item eligibility determination flow charge in Table 4 of the permit announcement among the items that have been permitted or certified.
3. The items eligible for review
Grade 2 medical devices that have been designated by the Minister of Food and Drug Safety as per the tables of the Rules on the Medical Device Classifications and Grades.
4. Items not applicable
  • The medical devices that are not fundamentally the same with a previously permitted medical device in terms of the structure, principle, performance, purpose, and whom it is used; the medical devices that require the submission of clinical trial data
  • Medical devices for U-health care
  • A medical device which has not been classified for the sub-category, so that a new classification item must be created.
  • The medical devices which are joined and form a combined unit with medicine or a non-medicinal product
  • Medical device for exportation
  • Product of equivalence announcement
  • A medical device that has been confirmed to be the same product
  • A medical device with a minor change

Application documents

  • A written request for the review of the technical documentation for a medical device, etc  Link
  • How to fill out the review request form for the technical documents of a medical device  Download
  • [Appendix 3] The table for the comparison with a fundamentally same product.  Download
  • [Appendix 5] The comparison table for fundamental equality for extracorporeal diagnosis medical devices  Download
  • [Appendix 13] The confirmation report for the conformance of the software for a medical device  Download
  • [Appendix 13] How to prepare the confirmatory report for the conformance of the software for a medical device  Download
  • The required documents for a change review for technical documents  Download

The process of the review of technical documents and how to apply

How to apply

CD or e-mail application(ktcmed@ktc.re.kr) (Your application will be reviewed within three days and an e-mail advising the formal registration of application will be sent.)

How to apply

  • Review of the technical document : within 25 days
  • Change review : within 15 days (* excluding public holidays and the time is taken to complement the technical document.)

Fees (VAT not included)

Items Assessment fee (won)
Technical document review Sterile medical devices, system medical devices, a combination of the medical devices that belong to the same group, and sets of medical devices (combining two functions, medical suppliers, dental materials, and in-vitro reagents are not included.) 1,800,000
Items other than the medical devices named above 1,400,000
Change review 1,100,000
  • Responsible department: Medical Assessment Center
  • TEL: Electrical area (031-428-3725), Supplies area (031-428-3726), In-vitro reagent area (031-428-3725, 3726)

Related laws and systems

  • Article 6 (The permit for manufacturing businesses), MEDICAL DEVICES ACT
  • Article 15 (The permit for importation businesses, etc.), MEDICAL DEVICES ACT
  • Article 4 (The parties subject to the manufacturing permit, manufacturing certification, and manufacturing reporting requirements), Enforcement Rules of the Enforcement Rules
  • Article 5 (The process of manufacturing permit), Enforcement Rules of the MEDICAL DEVICES ACT
  • Article 6 (The process of manufacturing certification), Enforcement Rules of the MEDICAL DEVICES ACT
  • Article 9 (The review of technical documents), Enforcement Rules of the MEDICAL DEVICES ACT
  • Article 26 (The request for the permits for changing the items of permits), Enforcement Rules of the MEDICAL DEVICES ACT
  • Article 30 (The application for importation permits, etc.), Enforcement Rules of the MEDICAL DEVICES ACT
  • The Rules on the Permits, Reporting, and Assessment of Medical Devices
  • The Rules of the Classes and Grades of the Items in Each Class of Medical Devices

The links to the related organizations

Ministry of Food and Drug Safety www.mfds.go.kr
National Institute of Food and Drug Evaluation www.nifds.go.kr
The online service page of the MFDS emed.mfds.go.kr
The online service page of the MFDS emed.mfds.go.kr
Medical Device Information Technology Support Center www.mditac.or.kr

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

Jump to the Medical Assessment Team for the Review of the Technical Documents of Medical Devices.

최종수정일: 2020-11-03 오후 7:57:57