Meeting with CMDE Quality Administration Division on DRAFT Guideline on Medical Device Technical Review and Consultation

2016-08-04 | Beijing

Li debriefed the background of developing this guideline. The key purpose is to standardize the consultation, so as the reviewers have more time focusing on reviewing submissions, eventually benefits shorter review timeline.

We expressed our understanding to that, meanwhile we suggested keep necessary pre-consultation for complicated products to be registered at CFDA. Secondly, we suggested remove limit to times of consultation. We also committed to provide practices of US FDA and EU on this regards, for their reference.

AdvaMed (The Advanced Medical Technology Association), an industry association of US, had two representatives for the meeting. We had joint efforts delivering industry concerns and recommendations.