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Technical documents

Technical documents

Introduction

Examination of the technical document of medical equipments

KTR has been designated by the Ministry of Food and Drug Safety as a 「Civil examination institute for medical device technical documents」 in accordance with relevant laws and regulations. KTR conducts the examination of technical documents for medical equipments of grade 2.

Medical equipments whose technical documents need to be examined

  • - All medical equipments of grade 2, in accordance with the 「Regulations on the medical devices and their classification」 issued by the Ministry of Food and Drug Safety
  • - However, the following medical equipments must be excluded from this examination, though they are in grade 2
  • 1. The medical equipment whose structure / principle / performance / use purpose and usage method are different from those equipments that have already been approved/certified.
    And medical equipments that require clinical trial data. For in-vitro diagnostic medical equipments, those equipments that require submission of clinical performance test data
  • 2. U-Healthcare medical equipments in accordance with 「Regulations on the medical devices and their classification」
  • 3. The medical equipments that need to be designated as new items, since the items (subcategories) of the 「Regulations on the medical devices and their classification」 have not been notified.
  • 4. Medical equipments combined or compounded with medicines or quasi-drugs

Procedure in examination of the technical document of medical equipments

Procedure in examination of the technical document of medical equipments 확대
  1. 1. Consultation regarding the reception of technical documents‘ examination (List to be reviewed and documents required)
  2. 2. Reception of technical documents‘ examination (Payment of charges)
  3. 3. Examiner assignment and examination
    • 4-1. 25일/15일 이내 기술문서 결과 통지서 발행
    • 4-2. Request for complement → Return
Result of the examination noticed

Examination criteria of the technical document of medical equipments

Regulations on permission, notification and examination of medical equipments (notified by the Ministry of Food and Drug Safety)

Charges required in technical documents‘ examination

  • 1. Request for examination of documents such as technical documents of medical equipments (Form of our institute. The details need to be prepared as attachment)
  • 2 .Table of changes (only for examining the changes of technical documents)
  • 3 .Attached documents
General medical equipments (electric, supplies, dental materials, etc.) and In-vitro diagnostic medical equipments (reagents)
General medical equipments (electric, supplies, dental materials, etc.) In-vitro diagnostic medical equipments (reagents)
  • 1. Data compared to products already permitted and certified (Form of our institute)
  • 2. Data on purpose of use (if applicable)
  • 3. Data on the operation mechanism (if applicable)
  • 4. The following data to confirm the performance and safety of the product (if applicable)
    • 1) Data regarding the electrical and mechanical safety
    • 2) Data regarding the biological safety
    • 3) Data regarding the safety to radiation
    • 4) Data regarding the electromagnetic safety
    • 5) Data regarding the performance
    • 6) Data regarding the physical and chemical properties
    • 7) Data regarding the stability
  • 5. Data on its origin, discovery and development process (If applicable)
  • 6. Data on the usage in foreign countries (if applicable)
  • 1. Data compared to products already permitted and certified (Form of our institute)
  • 2. Data on development progress, measurement principle and method, and domestic and overseas usage status (If applicable)
  • 3. Data on raw materials and its production methods (If applicable)
  • 4. Data on purpose of use (If applicable)
  • 5. Data on storage method, period of use or expiration date (If applicable)
  • 6. Data on purpose of use (If applicable)
  • 7. Data on the safety of the person handling in-vitro diagnostic medical equipments (If applicable)

Deadline of handling the examination of technical documents

  • 1. Examination of technical document of medical equipments : Within 25 days
  • 2. Examination of changes in technical document of medical equipments : Within 15 days

Required documents when examining the technical document of medical equipments

Required documents when examining the technical document of medical equipments
Classification examination charge (KRW) remarks
General medical equipments (simple product) 1,400,000 VAT excluded
Systems, etc. * 2,000,000
Examination of changes 1,000,000

※ System, etc.* : Examines the ‘system/sterilization/composition’ of the product to be examined

Request of technical documents‘ examination

After preparing the necessary documents, apply by email (mddr@ktr.or.kr) or visiting us