FAQ
Medical Devices

When applying Transfer of a Medical Device License, I have prepared the required documents according to the instructions stated on the FDA website, but I still received a request for additional documents. Other than the documents stated on the FDA website, what documents do I need to submit in this case?

刊登日期:2019-07-11  |  點閱次數 : 126 次 

Please refer to Article 29 of the Regulations for Registration of Medical Devices for information on the documents that should be attached to a license transfer application:  

(1) Application Form for a Change of Medical Device License.

(2) Original copy of the medical device license.

(3) Original copy of the letter of assignment issued by the pharmaceutical firm transferring the agency rights (assignor).

(4) An affidavit from the pharmaceutical firm receiving agency rights (assignee) affirming responsibility for the transferred medicament.

(5) Original copy of the foreign original manufacturer’s authorization certificate; its content shall describe, in detail, information about termination of the rights of the assignor and the bestowing of such rights to the assignee. It shall also state the product name and the names and addresses of the assignor and assignee. The certificate is valid for 1 year from the date of issue by the original manufacturer.

(6) Affidavit (A).

(7) A photocopy of the assignee’s pharmaceutical firm license.

The application for registration shall be made jointly by the assignor and the assignee; the “Application Form for a Change of Medical Device License” and the “Letter of Assignment” shall be jointly prepared by the assignor and the assignee. Both the application form and the letter of assignment shall clearly note the name and address of both the assignor and assignee, and the official seal of both parties shall be affixed to both documents.

The authorization certificate from the foreign original manufacturer shall contain two critical keywords, namely “termination” and “transfer” (i.e., its content shall comprehensively explain details about the termination of the rights of the assignor and the bestowing of such rights to the assignee). The authorization certificate shall also clearly state the name, specification, and model of all authorized product(s), and the names and addresses of the assignor and assignee.

 

(中文版)


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