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Medical Device
  • Q11

    What are the principles for approval of instruction leaflets, scope of approval and principles for subsequent changes to the import licenses of medical devices?

    When applying for registration, the foreign original instruction leaflet should be attached as the basis for Chinese translation and approval. However, in the case where the content is inappropriate for the conditions in Taiwan, improper claims or insufficient verification data, such content will not be included in the Chinese instruction leaflet after review, and the approved content is limited to the description in the Chinese instruction leaflet. Because of this, the foreign original instruction leaflet will not be included in the scope of approval; it will be retained for future reference without being subsequently bound with the approved version.

    However, if detailed procedures for operation, maintenance and use are deemed limited to professionals after review, they can be stated in the Chinese instruction leaflet by a statement such as “Please read the instruction manual provided by the manufacturer before use and follow the instructions.” 

    In the future, if there is any change to the foreign original instruction leaflet, but the content does not affect the content specified in the Chinese version, the applicants can retain the revised foreign original instruction leaflet for their own future reference without changing the information registered. For the approved version of the instruction leaflet bound with foreign original instruction leaflet, the same principle applies if there is any update to the foreign original instruction leaflet. 

    For details of the approval of instruction leaflet, please refer to the FDA ChiZi No. 1001604478 letter, Principles for Approval of Instruction Leaflet for the Import License for Medical Device, issued by the Food and Drug Administration on June 2, 2011 and the FDA ChiZi No. 1001607630 letter, Principles for Approval of Instruction Leaflet for the Import License for Medical Device and Procedures for Subsequent Changes, issued on August 10, 2011.
     
  • Q12

    What is the Certificate to Foreign Government?

    Definition: The Certificate to Foreign Government is a certificate issued by the central health competent authority in the country where the medical device is manufactured. The content shall state the name and the address of the manufacturer, the name of medical device, the specifications and model of medical device, the circumstances of manufacture, and the certification of approval for sale in the country. This is a document that is necessary for the application for registration of medical devices. This document may be referred to as the following names by foreign governments: Certificate to Foreign Government, Certificate of Free Sale, Free Sale Certificate, etc. For the actual format, please refer to the example of Certificate to Foreign Government and example of Certificate of Eligible Sale in the EU on the webpage “original Certificate to Foreign Government issued by the country of manufacture (exempted for domestically manufactured devices) (including examples)” on the Administration’s website.

    Contract Manufacture: If the imported medical device is a contract manufactured product and is not sold in the country where the commissioned manufacturer is located, the Certificate to Foreign Government can be replaced by (1) the Free Sale Certificate issued by the country of the commissioning manufacturer and (2) the manufacture certificate issued by the country where the commissioned manufacturer is located.  For example, product B is a product of a US-based company but is manufactured by a commissioned manufacturer in Japan. If product B has been approved for sale in Japan, the applicant shall submit the Certificate to Foreign Government issued by Japan’s highest health competent authority (Ministry of Welfare). If product B has not been sold in Japan, the applicant should submit the manufacture certificate (including the name and the address of the manufacturer, the name of medical device, the specifications and model, the circumstances of manufacture, and excluding “approved for sale in the country”) issued by Japan’s highest health competent authority and the Free Sale Certificate (including the name and the address of the manufacturer, the name of medical device, the specifications and model and the certification of approval for sale in the country) issued by the US’s highest health competent authority (Food and Drug Administration, i.e. FDA).

    Precautions: The validity of the aforementioned Certificate to Foreign Government, Manufacture Certificate and Free Sale Certificate shall be limited to two years from the date on which they are issued and shall be notarized by an overseas organization (such as Taiwan's embassy or consulate, representative office, other official office, or overseas organization in that country authorized by the Ministry of Foreign Affairs, etc.; the Certificate to Foreign Government issued by China has to be notarized at the Straits Exchange Foundation). If the certificates are not in English (e.g. Spanish, Japanese, Portuguese, etc.), Chinese or English translations shall be attached and the translations shall be notarized as well.

    Use of photocopies: Sometimes a Certificate to Foreign Government may include several products. The applicant can attach the original in the first application and use photocopies for other applications. However, the applicant shall make a note stating which case number the original copy is attached to on photocopies so that the reviewers can verify it.
     
  • Q13

    Does Taiwan accept the Export Certificate issued by the US FDA in place of the Certificate to Foreign Government?

    No. The Export Certificate means the product cannot be sold in the US. Its requirement is different than the Certificate to Foreign Government.