Medical Devices Act Article 22

Medical device manufacturers shall establish a medical device quality management system governing the on-site facilities, equipment, organization and personnel, production, quality control, storage, logistics, customer complaints, and other matters and shall comply with the quality management system regulations.Medical device manufacturers shall establish a medical device quality management system in accordance with the provisions of the regulations set forth in the preceding paragraph, and the manufacture may only begin after receiving a compliance inspection by the central competent authority and obtaining a manufacturing license. However, product items announced by the central competent authority shall not be required to obtain a manufacturing license.The provisions of the preceding two paragraphs shall apply mutatis mutandis to overseas manufacturers importing medical devices, and the central competent authority shall send personnel to the premises of such overseas manufacturers for inspection on a periodic basis or as necessary.The quality management system regulations set forth in Paragraph 1 and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, change, revocation, or cancellation of approval referred to in Paragraph 2, and other matters to be complied with shall be established by the central competent authority.