China: CFDA restricts questions companies can ask about the technical reviews of their marketing application

On October 20, 2016 the China Food and Drug Administration (CFDA) has issued a revised guidance on how it deals with questions about technical reviews in marketing applications. In the revised version the agency is restricting the scope of the questions medical device companies can generally ask about the technical review of their marketing applications. Inquiries from applicants about the regulator’s review of a class II or III device can now only relate to the content of a request for supplemental information by CFDA.

In the same time, the agency is increasing the number of channels through which questions can be submitted.
The revised guidance maintains the onsite and telephone channels for asking questions and adds two new inquiry channels – an online platform and a Center for Medical Device Evaluation FAQs platform.

For the revised guidance please click here.

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