FAQ
Medical Devices

What should I do if I am unable to obtain a manufacture and free sale certificate issued by the health authority of the manufacturing country because the product is not listed as a medical device in said country?

刊登日期:2019-07-11  |  點閱次數 : 664 次 

If the product is not listed as a medical device in the manufacturing country, the applicant can submit the following documents as a substitute for a manufacture and free sale certificate:

(1)  A certification document issued by the highest competent authority that clearly indicates that said product is not regulated for use as a medical device in the manufacturing country;

(2)  A covering letter issued by the local health agency explains that the manufacturing and free sale documents for said product can be substituted by that issued by relevant notified bodies. The manufacturing and free sale documents issued by the relevant notified bodies should also be attached.

 

(中文版)


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