| Scope: |
This CRF describes the regulatory requirements of In-Vitro Diagnostics medical devices in South Korea, based on the
- Act on In-Vitro Diagnostic Medical Devices and its enforcement regulations
- Additional information from Korean MFDS webpages
In-Vitro Diagnostics products are classified into four risk classes, according to the risk associated with their use:
Class I - very low
Class II - low
Class III - moderate
Class IV - high
The classification is harmonized with the IMDRF rules.
Not in scope of this CRF:
- Medial Devices (see: CRF KOR Medical Devices)
|
| Legislation in force: |
Article 2 - Definitions
The term “In-Vitro diagnostic medical device” means any of the following medical devices under Article 2 (1) of the Medical Devices Act, such as reagents, contrast agents, calibrators, equipment, machine, devices, and software, which are used independently or in combination of others for the purpose of conducting In-Vitro tests of specimens originated from humans or animals:
(a) Products used for the diagnosis of physiological or pathological conditions;
(b) Products used to determine the causes of diseases or to observe the prognoses of diseases;
(c) Products used to provide information on birth defects;
(d) Products used to provide information required for judgment on safety and suitability in cases of transplantation of tissues or blood donation;
(e) Products used for the purpose of predicting the response to and outcome of treatment;
(f) Products used for the purpose of determining treatment methods or monitoring treatment effects or side effects;
2. The term "specimen" means tissues, cells, blood, body fluids, urine, feces, etc. collected or extracted from the human body or animals as well as serum, plasma, chromosome, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), protein, etc. separated therefrom;
3. The term "clinical performance study" means an analysis of specimens to verify results related to clinical, physiological, and pathological conditions for the purpose of demonstrating the performance of In-Vitro diagnostic medical devices.
Article 11 regulates the Import Business Permission.
The Decree defines:
- which institutions are allowed to perform Clinical Performance Studies
- Third-party Certification of In-Vitro Diagnostic Test in Clinical Laboratories
- working standards of the Committee of Experts on In-Vitro Diagnostic Medical Devices
Article 2 - Definitions (excerpt):
2. "In-Vitro diagnostic equipment" refers to instruments, machines, devices, software, etc. among In-Vitro diagnostic medical equipment
3. "Identical product group" refers to In-Vitro diagnostic medical devices with the same country of origin, manufacturer, and item name that have the same purpose of use, method of use, manufacturing method, and raw materials (excluding In-Vitro diagnostic devices) that differ in color, size, etc., or have different parts. It refers to a product family consisting of models that are changed or added.
5. "Combined In-Vitro diagnostic medical device" refers to any of the following items.
- An In-Vitro diagnostic reagent that is composed of two or more In-Vitro diagnostic reagents and can perform more than one test
- In-Vitro diagnostic equipment that exhibits complex functions as two or more types of In-Vitro diagnostic equipment are gathered to form one In-Vitro diagnostic equipment (including two or more types of In-Vitro diagnostic equipment from the same manufacturer connected to continuously perform different In-Vitro diagnostic tests)
6. "In-Vitro diagnostic medical device in a set" refers to a product composed of two or more types of In-Vitro diagnostic medical devices, etc., in one packaging unit.
11. "Equivalent product" refers to a product that is equivalent to an In-Vitro diagnostic medical device that has already been licensed and certified in terms of purpose of use, principle of action, and all of the following items.
- In-Vitro diagnostic reagents: raw materials, performance
- In-Vitro Diagnostic Equipment: Performance, Test Specifications, How to Use
12. "Improved product" refers to a product that is equivalent to an already licensed/certified In-Vitro diagnostic medical device in purpose of use and principle of action
13. "New product" refers to a product that is not equivalent in purpose of use or principle of action to an In-Vitro diagnostic medical device that has already been licensed and certified.
15. "In-Vitro diagnostic equipment product family" means a series of products with the same manufacturer/country of manufacture, item name (grade), purpose of use, measurement principle, sample type, applied in vitro diagnostic reagent, and different technical specifications such as test speed and calibration method. It refers to In-Vitro diagnostic equipment composed of models (series products).
16. "All-in-one IVD medical device" refers to an IVD medical device that is designed and manufactured by the same manufacturer of IVD reagent and IVD equipment and has the same purpose of use.
|