FAQ
Medical Devices

For a Mexican manufacturer operating under the Maquiladora program, does the FDA recognize USFDA certificates of manufacture and free sale that issued to such a manufacturer?

刊登日期:2019-07-11  |  點閱次數 : 73 次 

According to FDA announcement date July 25, 2006: For market registration of the products produced by Mexican manufacturers under maquiladora Program, the manufacture and free sale certificate issued by the USFDA may be accepted only when the the Maquila Certificate (Ampliacion de Programa de Maquila de Exportacion [a Chinese or English translation shall be attached when the verification documents are not in English]) is also attached.

 

** For samples and explanations of an original copy of manufacture and free sale certificate issued by the government of the country where the imported medical device is manufactured, please refer to the following relevant links:
Samples of the Maquiladora program verification documents_2006 version (2nd revision)

Samples of the Maquiladora program verification documents_2007 version (2nd revision)

 

Related link:

Samples of the original copy of certificate of manufacture issued by the government of the manufacturing country (waived for domestic products)

 

(中文版)


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