ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

The purpose of this Act is to improve public health and contribute to the advancement of in vitro diagnostic medical devices through ensuring safety, improving quality, and strengthening international competitiveness, of such devices by providing for matters necessary for handling, such as manufacturing and import, and management of, and support for the devices.

Article 2(Definitions) #

The terms used in this Act are defined as follows: <Amended on Jan. 2, 2024>

1. 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;

(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.

4. The term “performance evaluation” means an assessment conducted to verify the performance of an in vitro diagnostic medical device, including clinical performance studies and tests using reference materials to confirm performance-related outcomes of the device.

ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Classification and designation of classes) #

Article 4(Relationship to other statutes) #

Article 5(Permission for manufacturing business) #

Article 6(Concurrent review of companion diagnostic medical devices and drugs) #

Article 7(Clinical performance study) #

Article 8(Clinical performance study institutions) #

Article 9(Training for persons engaging in clinical performance studies) #

Article 10(Permission for modification) #

Article 11(Import business permission) #

Article 12(Certification of in vitro diagnostic test in clinical laboratories) #

Article 13(Labeling on containers) #

Article 14(Labeling on outside package) #

Article 15(Labeling on package inserts) #

Article 16(Reporting and inspection) #

Article 17(Inspection order) #

Article 17-2(Orders to repair facilities) #

Article 17-3(Performance evaluation) #

Article 18(Revocation of permission and suspension of business affairs) #

Article 19(Revocation of designation) #

Article 20(Imposition of penalty surcharges) #

Article 21(Committee of experts on in vitro diagnostic medical devices) #

Article 22(Support) #

Article 23(Promotion of collection and use of information on in vitro diagnostic medical devices) #

Article 24(Manufacture of reference materials for in vitro diagnostic medical devices) #

Article 24-2(Request for provision of specimens and data) #

Article 25(Hearing) #

Article 26(Delegation and entrustment of authority or duties) #

Article 27(Legal fiction as public officials in application of penalty provisions) #

Article 28(Special cases concerning in vitro diagnostic medical devices for animals) #

Article 29(Penalty provisions) #

Article 30(Penalty provisions) #

Article 31(Penalty provisions) #

Article 32(Joint penalty provisions) #

Article 33(Administrative fines) #