A manufacture and free sale certificate (hereafter called “certificate” for short) is not required for domestically manufactured medical devices.
The certificate shall be issued by the highest health authority of the country and shall state the following particulars:

1. Name and specifications and/or model number of the medical device.
2. Manufacturer's name, address, manufacturing status, and actual status for domestic sale as approved in that country.

    This certificate may be replaced by a document issued by other authorities or another document in accordance with the following provisions:
1. If the medical device is not regulated by the highest health authority in manufacturer's country, this document may be issued by the local health agency or an organization approved by the central competent authority of the Republic of China (Taiwan).

2. If the medical device is commissioned to be manufactured, this document may be issued by the highest health authority in the country where the contract party or the contract manufacturer is located.

3. If the medical device involves contract manufacturing and it is not sold in the country where the contract manufacturer is located, this document may be replaced by a free sale certificate issued by the highest health authority in the country where the contract party is located, and a manufacture certificate issued by the government of the country where the contract manufacturer is located.

4. This document may be replaced by a manufacture certificate issued by the government of manufacturer's country and a free sale certificate issued by the highest health authority of the United States of America or of a European Union Member State.

5. If the medical device is a world's first product with no predicate, a report from the central competent authority after conducting an on-site inspection of the foreign medical device manufacturer and a report of medical device clinical trials carried out in the Republic of China (Taiwan) shall be submitted for the exemption from submitting the manufacture and free sale certificate of the country of origin.

    The certificate shall remain valid for two years from the date of issuance, and shall be notarized by Republic of China's (Taiwan's) overseas embassy or consulate, representative office, other official office stationed in the region, or overseas organization authorized by the Ministry of Foreign Affairs (also referred to as the ROC overseas representative office). If the certification document is not issued in English, a Chinese or English translation shall be submitted at the same time and the translation shall be notarized. However, those issued by the highest health authority of a country that has established technical cooperation agreement with the Republic of China (Taiwan) for the premarket review of medical devices or those recognized by the central competent authority are exempt from notarization

    If the original copy was submitted to TFDA (or the Ministry of Health and Welfare) earlier for another application, a copy may be used instead; nevertheless, the application number and product name for the original copy submission shall be provided, and posteriorly confirmed by the reviewer.