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ICMC (International Certification Management Center Co., Ltd.)

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+82-2-851-3111

Animal Medical Device

Definition of animal medical device for in Korea (QIA)

Products falling under any of the following subparagraphs as equipment, machinery, equipment, materials, or similar products used alone or in combination with humans or animals (Article 2 of the Medical Devices Act)


  • Products used for the purpose of diagnosing, treating, mitigating, treating, or preventing
  • Products used for the purpose of diagnosing, treating, mitigating, or correcting injuries or disabilities.
  • Products used to inspect, replace, or transform structures or functions.
  • It's a product used to control pregnancy.
    Animal medical devices are medical devices for the purpose of use as animals and refer to those determined and announced by the head of Animal and Plant Quarantine Agency.


Classification of animal medical device (general)

NO content
class 1
 Medical devices that do not come into direct contact with animals or have little potential risk even if they come into contact with them, and have a minor impact on animals even in the event of a failure.
class 2 Medical devices with low potential risks, although there is a risk to animals due to failure or abnormalities during use, but are unlikely to face life risks or significant dysfunction.
class 3 Medical devices that have been inserted and used in animals for a certain period of time or have a high potential risk.
class 4 Medical devices used in direct contact with the heart permanently transplanted into animals, using animal tissues, extracts, or medical devices used for new purposes, or raw materials with insufficient information for verification of safety.


Classification of animal medical device - In vitro diagnostic medical device

NO content
class 1
 Reagents with low potential risk to individuals and public health
Reagent used for general purpose diagnosis.
(e.g. strain identification medium, tissue staining reagent, etc.)
class 2 Reagents with potential risk of severity to animals and low potential risk to public health.
(e.g. various protein and microbial detection reagents such as cholesterol and vitamins)
class 3 Reagent with high potential risk to animals and severe potential risk to public health
Reagents used in tests that have a decisive effect on diagnosis, treatment, disease stage determination, and treatment.
(e.g. sexually transmitted diseases, genetic diseases, cancer diagnostic tests, etc.)
class 4 Reagents that pose a high risk to animals and public health.
A test to select donors for transfusion or transplantation of other animals.
(e.g. ABO blood type determination, HIV, HBV, HCV, HTLV diagnostic reagent)



The procedure for applying for permission to manufacture/import animal medical devices operated by Korea (QIA)

Animal Medical Device



Organizations related to animal medical device manufacturing/ import permission in Korea


NO Name of the Organization Work content
1
Animal and Plant Quarantine Agency (QIA)
Permission to manufacture/import animal medical devices
Manufactured/imported product permission (report)
Change of manufacturing/import business permission
Changed manufacturing/import product permission
Confirmation of animal medical device for testing, etc.
2
Korea Testing Laboratory (KTL)
Examination of all 39 items
3
Korea Testing Certification Institute (KTC)
Test inspection of 27 items, including radiation treatment devices
4
Korea Medical Devices Industry Association (KMDIA)
Standard customs clearance scheduled report management and performance report management of imported medical devices.



Animal medical device RA consulting stage in Korea

consulting stage



Related major websites

Animal and Plant Quarantine Agency