This document is not required if the products are manufactured in Taiwan.

    The contents in the original authorization letter must be consistent with the free sale certificate or certificate to foreign government.

    This document shall record the following particulars:
1. The original manufacturer authorizes an agent in the Republic of China (Taiwan) to apply for registration and market approval and agrees to coordinate with the agent in the Republic of China (Taiwan) to comply with relevant medical device regulatory requirements.
2. It specifies the name and address of medical device firm commissioned or authorized to register, as well as the name and specifications and/or model number of medical device. Moreover, descriptions such as “authorized to register” must be listed.

    This document may be replaced by other documents in accordance with the following provisions:
1. A certification document for authorized agent issued by the headquarter company of the imported medical devices that authorizes the agent in the Republic of China (Taiwan) to apply for registration and market approval. Its contents explicitly state the name and address of manufacturer and specify the name and address of medical device firm commissioned or authorized to register, as well as the name and specifications and/or model number of medical device.
2. The original manufacturer of imported medical devices issues a certification document stating its foreign agent, and then the foreign agent issues a certification document for authorized agent, which authorizes the agent in the Republic of China (Taiwan) to apply for registration and market approval and explicitly states the name and address of medical device firm commissioned or authorized to register, as well as the name and specifications and/or model number of medical device.

    This document shall remain valid for one year from the date of issuance. If it is not issued in English, a Chinese or English translation shall also be submitted at the same time.

    If the original document was already submitted to the TFDA (or the Ministry of Health and Welfare) for another application, the copy of the document may be accepted under certain conditions. For example, the applicant must provide the case name and submitted number with which the original document was attached.

    A demo template of original authorization letter is valid as below:
/tc/includes/GetFile.ashx?id=f637553957307757041&type=2&cid=36625