This document refers to the certification document issued by the central competent authority stating that the medical device manufacturer conforms to the Medical Device Quality Management System Regulations.

    For medical devices that were originally regulated as pharmaceuticals and within three years from the date of announcing the regulatory change to medical devices, this document may be replaced by a copy of the certification document showing conformance to the Good Manufacturing Practices for Pharmaceuticals.

    Upon registration, if the manufacturing factory (manufacturers) has not yet acquired the certification, TFDA may still accept the application, albeit only temporarily; if such certificate document still has not been acquired by the last day of the application period, the registration will not be accepted and TFDA will not issue the license thereof.

    For imported medical devices, please ensure the name and address of the manufacturing factory are the same as those shown on the free sale certificate; for domestically manufactured medical devices, these should be the same as those shown on the medical device manufacturing license.

    The document is valid for 3 years from the date of issuance. Moreover, the specified item on the document must be in the same category as the product being applied for registration.