• Last updated：2024-08-13
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In accordance with the regulations of the Ministry of Health and Welfare (MOHW), for the manufacture and import of medical devices, an application shall be filed with the central governing authority for registration and market approval. No manufacture or import may be started until such approval is granted and a medical device license is issued. However, the manufacture and import of certain product items announced by the central governing authority shall be done by means of registration listing. The MDD is entrusted to evaluate technical files of medical devices to ensure their safety and effectiveness. For the application process regarding the inspection and registration of medical devices in our country, please refer to the provisions of the "Regulations for Governing Issuance of Medical Device Licenses and Annual Declaration.