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Key services of KTC

Testing and inspection

Bio and medical

Medical suppliers test

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Key services of KTC
Testing and inspection
Bio and medical
Medical suppliers test

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Medical suppliers test

Overview

Medical device testing

We provide the testing services for the entirety of the 25 testing items, since we are designated as a medical device testing agency by the MFDS. Our Medical Suppliers Center providers testing services for medical suppliers and in-vitro diagnosis reagents to ensure their safety (including biological safety, etc.) and effectiveness (analytical performance, mechanical performance, validation of the shelf-life and other indications on the product, etc.)

Medical device testing image
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Technical support
Not only medical device testing services, we provide various technical support services that are required during the development phase, such as setting the shelf-life specifications, etc. We will do our best to ensure customer satisfaction, based on our expertise.

Scope of Services

  • The test services for the review of the technical documents for medical devices
  • The item permit test for medical devices (manufactured/imported)
  • Independent testing services for self-initiated quality control of manufact users and importers
  • Technical support for product development, such as setting the shelf-life and sterility validation, etc.
  • Other technical support and research activities for the biological safety of the products and other bacterial tests
  • Research activities related to medical supplies, sterility, and in-vitro diagnostic reagents

Test areas

Biological safety tests
  • Cellular toxicity test
  • Acute toxicity test
  • Skin sensitivity test
  • Genetic toxicity test
  • Implantation test
  • Blood compatibility test
    And other biological safety tests in accordance with the announcement by the MFDS and international standards
Chemical tests
  • Exudation tests (appearance, pH, UV absorption spectrum, and heavy metal testing, etc.)
  • The test for confirming the validity of the EO gas residue test
  • Sterility validity test
  • Clean test, etc.
Performance test
  • Fatigue tests and other mechanical tests of orthopedic suppliers (artificial joints, fracture-joining screws, cardiovascular s tents, etc.)
  • Packaging validation
  • Shelf-life validation
  • Sterility validation
  • Clean-room validation x-ray non-penetration test
  • The test of the joinings of IV sets
Testing of reagents
  • Analytical performance test
  • Shelf-life test

* Cooperation with clinical trial centers (university hospitals) for evaluating reagents.

Medical device test items group (35 groups)

The groups of the items designated by the MFDS Address and contact information
All items other than the U-healthcare items
Including the reagents for the in-vitro diagnostic equipment		 Electronic medical devices: Medical Devices Center
Tel: 031-455-1747
Medical Supplies: Medial Supplies Center
Tel: 031-455-7260

Work Flow

Work Flow of Medical Suppliers Test image

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Documents related to a test request

A medical device test request  Medical Device Test Request
Other documents to be attached when making a test request
  • A medical device test request
  • Test samples (contact us for the exact number of the samples needed for testing)
  • A copy of the applicable technical documents (as per Paragraph 1, Item 1 under Article 5 of the Enforcement Rules of Medical Device Act)
  • For imported products, a copy of sample certificate, importation condition certificate, and importation permit
  • The domestic or foreign test reports of the product (if applicable)
  • Other documents necessary for testing
Documents related to a test request
01 Medical Device Act Download
02 The Enforcement Decree of Medical Device Act Download
03 The Enforcement Rules of Medical Device Act Download
04 The rules on the permits for medical devices Download
05 The rules on the evaluation of the technical documents regarding a medical device Download
06 The rules on the medical device types and the grades of each type Download
07 The standard for manufacture, importation, or quality control of medical devices Download
08 The rules on reporting the records of production, exportation, importation, and repair works of medical devices Download
09 The rules on the re-assessment of medical devices Download
10 The rules on the re-evaluation of medical devices Download
11 The rules on the management of the safety-related information regarding medical devices, including the reporting of side effects Download
12 The reference standard for the biological safety of medical devices Download
13 The reference standard for the electrical and mechanical safety of medical devices Download
Ministry of Food and Drug Safety (MFDS)
www.mfds.go.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

Medical Suppliers Test Jump to the website of the Medical Bio Team.

최종수정일: 2020-11-03 오후 7:54:34