Pharmaceutical Affairs Act Article 40

For the manufacture or import of medical devices, an application, together with fees paid, shall be filed with the central competent health authority for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device license is issued.Only the medical device license holder or their authorized persons may apply for the import of medical devices pursuant to the provisions of the preceding paragraph.The application criteria, review procedure, approval criteria, and other matters to be complied with for the application for registration and market approval, change, transfer, extension, replacement, and re-issuance of a medical device license shall be established by the central competent health authority.