FAQ
Medical Devices

My company address was changed due to governmental administrative area and house numbering adjustments. In this case, do I need to submit an application to change the address on the existing medical device license? Do I need to pay any fee for such a modification?

刊登日期:2019-07-11  |  點閱次數 : 112 次 

If the “company” you referred to is a retail pharmaceutical firm, kindly fax the modified pharmaceutical firm license containing the new address information to the FDA (fax number: +886-2-3322-9492), noting possession of the information of relevant medical device license. The address in the relevant database will be updated based on the submitted information. 

If the “company” you referred to is a manufacturing factory, please submit an application to the FDA to change the manufacturer’s address on the existing medical device license. Kindly refer to Article 28 of the Regulations for Registration of Medical Devices for information on the documents that should be attached to such an application.

According to FDA announcement dated September 2, 2014: for a change of manufacturer’s address on GMP documents and medical device licenses, the applicable fee may be waived if the change in address is a result of governmental administrative area and house numbering adjustments.

 

(中文版)


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