CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.
Abolition of Type Testing Fees in China appears to have led to a hiatus, with many test centers stopping Type Test Services. Does this indicate an impending policy change on Chinese Type Testing?
CFDA’s Centre for Medical Device Evaluation (CMDE) has reversed course on pre-consultations – re-establishing arrangements for informal preconsultations with reviewers at the CMDE Offices. Read on to learn about “Open Window Friday”
Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need. Is the pendulum starting to swing back?
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.