1. Reason for revision
In accordance with the revision of the Act on In Vitro Diagnostic Medical Devices (implemented on February 17, 2024), which allows entities other than clinical performance test centers designated by the Minister of Food and Drug Safety to participate in clinical performance testing of in vitro diagnostic medical devices, the proposed revision is designed to improve and supplement some of the deficiencies of the current system, including provisions newly established to define clinical performance tests that can be conducted by entities other than clinical performance test centers, and to provide standards on the dispositions that may be imposed in the event of non-compliance with the management and supervision of clinical performance test centers.
2. Main contents
a. It requires that information concerning the participating entities should be indicated in the clinical performance test plan (Article 13 of the draft).
When any entity other than a designated performance test center participates in a clinical performance test, the clinical performance trial plan or protocol must include information concerning the entities participating in the clinical performance trial.
b. It defines the tests in which entities that are not clinical performance test centers can participate (Article 14-2 of the draft).
It defines the clinical performance tests in which non-designated entities can participate under the administration of clinical performance trial centers, and also provides that the scope of the tests in which their participation is permitted should be defined.
c. It stipulates the level of compliance required by entities participating in clinical performance tests (Article 17 of the draft).
In order to ensure the reliability of clinical performance tests, it provides that tests should be performed within the scope requested by the clinical performance test center and under the administration and supervision of that clinical performance test center.
d. It provides guidelines or standards on the administrative dispositions that may be imposed on clinical performance test entities (Article 22 and Appendix 2 of the draft).
It imposes the obligation of administration and supervision by clinical performance test centers when administering and supervising participating entities to ensure that the latter conduct their tests in accordance with the performance and management standards. It also provides standards on the administrative dispositions that may be imposed in the event of violations of, or failure to perform, the obligation of administration and supervision.
