The Regulations are stipulated in accordance with Paragraph 2, Article 52 of the Medical Devices Act (hereinafter referred to as "the Act").

Terms used in the Regulations shall have the following meanings:
1. Inspection: This refers to batch-by-batch verification or examination or random-selected batch verification or examination of imported medical device before permitting the importation.
2. Verification: This refers to examination or verification of items, packaging, appearance, labels or other items of products carried out by inspectors in accordance with the law.
3. Examination: This refers to conducting sensory, chemical, biological, or physical examination or tests in a laboratory.
4. Inspection authorities: This refers to the central competent authority in charge of inspection of imported medical device or refers to the organization(s) appointed or commissioned by the central competent authority.
5. Obligatory inspection applicants: This refers to importers of medical devices.