FAQ
Medical Devices

What is a manufacture and free sale certificate? Is it necessary to state the relationship between the commissioning company and the contract manufacturer on this certificate for an imported medical device?

刊登日期:2019-07-11  |  點閱次數 : 204 次 

According to Article 7 of the Regulations for Registration of Medical Devices, manufacture and free sale certificates of the country of origin are verification documents issued by the highest health authority of the country where the imported medical device is manufactured. The content of such documents shall state the name and address of the manufacturer, the name of the medical device, the specifications and model of the medical device, the circumstances of manufacturing, and the certification of approval for domestic sale in that country. If it is confirmed that the medical device is not regulated by the highest health authority in the country of the manufacturer, these documents may be issued by the local health agency or an organization approved by Taiwan’s competent national health authority.

(1) Regarding the manufacture and free sale certificates in the preceding paragraph, if an imported medical device is commissioned to be manufactured in another country and the device is not on the domestic market of the commissioned manufacturing factory, a free sale certificate issued by the country’s highest competent health authority of the commissioning company and a manufacture certificate issued by the country’s competent authority of the commissioned manufacturing factory may be submitted instead of the foregoing manufacture and free sale certificate.

(2) In the event that the commissioned manufacturer is the applicant for an imported medical device, the manufacture and free sale certificates mentioned in the preceding paragraph are allowed to be issued by respective highest competent health authority of the country either of the commissioning company or of the commissioned manufacturing factory.

(3) The manufacture and free sale certificates stated in Paragraph 1 are allowed to be issued by a certificate of manufacture by the government of the country where the imported medical device is manufactured and a manufacture and free sale certificate issued by the highest competent health authority of the United States, or any member state of the European Union.

The verification documents in the three preceding paragraphs shall remain valid for 2 years after the date of issuance, and shall be notarized by the overseas representative organization of Taiwan of the respective country. A Chinese or English translation shall be attached when the verification documents are not in English, and the translation shall also be notarized.

 

● Scenario case of examples for commissioned manufacture of imported medical devices:

Canadian Company A commissioned Japanese Factory B to manufacture a product.

There are three options for a manufacture and free sale certificate:

(1) A manufacture and free sale certificate provided by A: If the product has been approved for sale in Canada, a manufacture and free sale certificate issued by Canada’s highest competent health authority can be attached to the application.

(2)  A manufacture and free sale certificate provided by B: If the product has been approved for sale in Japan, a manufacture and free sale certificate issued by Japan’s highest competent health authority can be attached to the application.

A market approval certificate provided by A and a manufacture certificate provided by B: If the product has been approved for sale in Canada but not Japan, a manufacturing certificate issued by Japan’s highest competent health authority and a manufacture and free sale certificate issued by Canada’s highest competent health authority can be attached to the application.

 

*Note:

(1) Governments of different countries may have different names for Manufacture and Free Sale Certificate, such as a Certificate to Foreign Government, Certificate of Free Sale, and Manufacturing and Free Sale Certificate. For the actual document format, kindly refer to the examples of the manufacturing and free sale certificate on the FDA website (Chinese version only): Original Copy of Certificate of Manufacturing Issued by the Government of the Manufacturing Country (samples included), section of the website and that of the European Union market registration certificate and the overseas representative organization of Taiwan of the respective country.  

(2) The manufacture and free sale certificate, manufacture certificate, and free sale certificate mentioned in the three preceding paragraphs must be valid for 2 years after the date of issuance, and they shall be notarized by an overseas representative organization of Taiwan of the respective country (e.g., embassy or consulate, representative office, other official office, or overseas organization in that country authorized by the Ministry of Foreign Affairs; the Straits Exchange Foundation is responsible for notarizing products manufactured in the mainland China area). A Chinese or English translation shall be attached when the verification documents are written in languages other than English (e.g., Spanish, Japanese, Portuguese), and the translation transcript shall also be notarized.

(3) Usage of photocopies: Occasionally, a manufacture and free sale certificate may contain information for multiple products and may be subjected to applications. In such case, the applicant can attach the original copy of the certificate in the earliest application, and provide a photocopy of the certificate in another application. However, the case number of the application that contains the original copy of the certificate shall be indicated in a written format to facilitate the review process.

For contract manufacturing, additional evidence to demonstrate the relationship between the commission company and the contract manufacture is currently required for market registration. As the FDA will give favorable consideration for recognizing the relationship, a “Contract Manufacturing Agreement” delineating the commissioning relationship is sufficient. It is not necessary to describe such information on the manufacture and free sale certificate.

 

(中文版)


上一筆 Can an export certificate issued by the USFDA be acceptable instead of a manufact
下一筆 For the application of a medical device originally manufactured in France, is it