FAQ
Medical Devices

In a QSD application, if the scope of the ISO 13485 certificate is too broad, are there any other alternative documents that can be used as a replacement for an explanatory letter issued by a notified body?

刊登日期:2019-07-11  |  點閱次數 : 109 次 

The review and registration of GMPs and QSDs in Taiwan are carried out based on the classification level of the medical devices. Therefore, if the scope of the ISO 13485 certificate is too broad, to the point that the certificate makes it difficult to determine the manufacturing categories of the manufacturer, an explanatory letter issued by the original notified body should be attached to the QSD application.

 

(中文版)

 


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