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Key services of KTC

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Bio and medical

GLP Testing

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Key services of KTC
Testing and inspection
Bio and medical
GLP Testing

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GLP Testing

The GLP testing for medical devices

According to Article 10-2 of the Medical Device Act and Item 4 under Article 24-2 of the enforcement rules of the same law, KTC has been designated by the MFDS as a non-clinical testing agency for medical devices, as it now has fully equipped itself with the dedicated GLP testing facilities. With this we now lunch the GLP testing service to prove the international reliability of the non-clinical data of medical devices, for our customers in the industries of manufacturing and importing medical devices.

The GLP testing for medical devices image
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The designated test areas and test items
  • Products to be tested : Grade 1 through 4 Medical Devices (finished products, semi products, parts, or their raw materials)
Test Sites Test Items
Reproduction toxicity, genetic toxicity, carcinogenicity test Genetic toxicity test (in-vitro genetic toxicity test)
Blood compatibility test In-vitro test (hemolytic)
Cellular toxicity test Extractables test, agar diffusion test
Irritation and skin sensitivity test Irritation test (animal dermis test) and skin sensitivity test
(Guinea pig tests for assessing skin sensitivity)
Systemic toxicity test Acute systemic toxicity test and exothermic test (material-mediated exothermicity)
The work flow for GLP testing
  • Products to be tested : Grade 1 through 4 Medical Devices (finished products, semi products, parts, or their raw materials)
    • Test inquiry
      • Non-clinical testing consultation
      • Test request and acceptance
    • Signing of a test contract
      • Preparation of a written test request
      • Preparation of a written contract for testing
      • Fee payment
      • Issuance of a tax invoice
    • Preparation for a test
      • Designation of the tester
      • Prepare a testing plan
      • Discussion with the client
      • Designation of the QAP
    • Execution of the tests
      • QAP review
      • Approval of the test plan
      • Approval of the test plan
    • DATA processing
      • Statistical processing and analysis
      • Checking the raw test data
      • QAU review
    • Preparation of the report
      • Review of the raw test data
      • Preparation of the final report
      • QAU review
      • Confirmation by the client
    • Test completion
      • Indexing the raw test data and review of the data
      • Issuance of a reliability certificate
      • Approval of the final report
    • Transfer of the test data
      • Transfer of the raw test data and digital data
      • Transfer of the final report
      • QAU review
  • Required documents :
    • Technical documents (appearance, purpose, raw materials, test standard, sample fluid preparation condition)
    • Test materials (consult with the person in charge for the amount)
    • The certificates for the medical device to be tested, the request for exemption in importation approval request, and importation report certificates (for imported medical devices only)
  • Precautions :
    • Make sure to provide accurate information on the tested material in the application form.
    • Provide the exudation rate and exudation temperature correctly in the form.
      (The client is to guarantee the correctness of the information provided regarding the materials that are provided for testing.)
    • The original of the final report shall be archived in the non-clinical trial agency, and the client shall be provided with a copy of the report.
The work flow for GLP testing
  • Inquiry and issuance
    • Medical Bio Team (Gunpo; Address: 74, LSro-115-gil, Gunpo-is, Gyeonggi-do), 031-428-3804, ghyun497@ktc.re.kr
    • Bio Health Center (Ochang; 57, Yangcheong-3-gil, Ochang-eup, Cheongwon-gu, Cheongju-is, Choongbuk), 043-299-6625, kmy812@ktc.re.kr, 043-299-6634, supravet@ktc.re.kr
  • Research service
    • 043-299-6621, twkim@ktc.re.kr

최종수정일: 2020-11-03 오후 7:54:35