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What is an animal medical device as defined in Korea (QIA) (Article 2 Paragraph 1 of the Medical Device Act)

Instruments, machines, devices, materials, or similar products used alone or in combination with humans or animals, which fall under any of the following subparagraphs:

  • 1) Products used for the purpose of diagnosing, treating, alleviating, treating or preventing disease
  • 2) Products used for the purpose of diagnosing, treating, alleviating or correcting an injury or disability
  • 3) Products used for the purpose of inspecting, replacing, or modifying the structure or function
  • 4) Products used for the purpose of controlling pregnancy
    - Medical devices for animals refer to medical devices intended for use for animals, which are determined and announced by the head of the Agriculture, Forestry and Livestock Quarantine Headquarters.

• Classification of medical devices for veterinary use (general)

No. Contents
Class 1 Medical device that does not come into direct contact with animals or has little potential risk even if it comes into contact with animals, and has a slight effect on animals even when a malfunction occurs
Class 2 Medical device with low potential risk because there is a risk to animals due to malfunction or abnormality during use, but there is little possibility of facing life or serious dysfunction
Class 3 Medical devices with high potential risk or inserted into animals for a certain period of time
Class 4 Medical devices that are used in direct contact with the heart, etc. permanently implanted in animals, or medical devices that use animal tissues or extracts, or that use raw materials for which there is insufficient information for safety verification, or medical devices used for new purposes, etc.

• Classification of medical devices for animals (in vitro diagnostic reagents)

No. Contents
Class 1 Reagents with low potential risk to animals and public health. A reagent used for general diagnostic purposes.
(e.g. bacterial identification medium, tissue staining reagent, etc.)
Class 2 A reagent with a moderate potential risk to animals and a low potential risk to public health.
(e.g. Cholesterol, vitamins, etc., various protein and microorganism detection reagents, etc.)
Class 3 A reagent with a high potential risk to animals and a moderate potential risk to public health.
Reagents used in tests that have a decisive effect on diagnosis, treatment, disease staging, and treatment.
(e.g. sexually transmitted disease, genetic disease test, cancer diagnostic test, etc.)
Class 4 Reagents that pose a high risk to animals and public health. A test that selects donors for transfusion or transplantation into other animals
(e.g. ABO blood type determination, HIV, HBV, HCV, HTLV diagnostic reagent)

Application procedure for product approval for manufacturing/importing medical devices for animals operated by Korea (QIA)

Korean veterinary medical device manufacturing/import license-related institutions

No. Organization name Business information
1 Agriculture, Forestry and Livestock Quarantine Headquarters QIA Permission for manufacturing/importing medical devices for animals Manufactured/imported product permission (report) Change of manufacturing/import business license Changed manufacturing/import product license Test medical device confirmation, etc.
2 Korea Testing Laboratory KTL Testing and inspection of all 39 items
3 Korea Testing Certification Institute KTC Test and inspection of 27 items including radiation treatment equipment
4 Korea Medical Devices Industry Association KMDIA Management of scheduled customs clearance report for imported medical devices and performance reporting management
美国 CERT 可以通过与相关组织合作，提供专业的技术支持，以满足客户在韩国制造和销售体外诊断医疗器械的需求和法律要求。此外，我有信心通过成功获得国内体外诊断医疗器械许可证，重生为一家有前途的公司