Medical Devices Act Article 25

For the manufacture and import of medical devices, an application shall be filed with the central competent 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. However, the manufacture and import of product items announced by the central competent authority shall be done by means of listing.Medical devices that shall apply for registration and market approval in accordance with the preceding paragraph shall not do so by means of listing.The import of medical devices shall be done by license holders, those who have completed the listing, or their authorized persons.If the medical device that shall be listed in accordance with the exception of Paragraph 1 has obtained medical device license approval before this Act becomes effective, the central competent authority shall complete the listing directly, cancel the original license, and notify the original license holder.