These regulations are promulgated pursuant to the Paragraphs 1 and 2 of Article 78 of the Medical Devices Act.

Definition of the terms herein employed are as follows:
1. Testing institution: It refers to a testing body (institution), corporation, or group possessing the capacity to implement medical devices testing.
2. Accreditation: It refers to the procedure established under this set of regulations instituted to validate the testing competence of a testing institution for a particular testing item.