Meeting with CFDA, Center for Medical Device Evaluation (CMDE)

2014-11-27 | All chapters

Chairs emphasized to Director CAO that industry is not clear about how to prepare clinical data for registration submission, and if local China clinical trial is required, industry is also not clear about corresponding requirements, since the guidance/GCP has not been published.

CAO preliminarily agreed to have a seminar with industry on clinical related issues. For seminar/workshop on clinical evaluation practice that industry proposed to have with CMDE in China and in Europe, CAO also shared his opinion on purpose of the trip, Itinerary, attendees from their perspective, etc.