On February 7, 2014, the CFDA announced the “Procedure for Examination and Approval of Innovative Medical Devices (Trial)” that will go into effect March 1, 2014. According to the CFDA, this new process will increase the efficiency of innovative medical device review and approval, encourage research into and the development of innovative devices, expand popularization of new technologies, and promote the device industry. Both domestic and foreign medical devices are eligible.
Once an application has been accepted as having met the criteria for this fast track process, the application will receive priority at every stage of the approval and review process. The process will now be managed by the CFDA’s new Examination Office for Innovative Medical Devices. Both the Provincial FDA and the CFDA will communicate with the applicant in a timely manner, as well as provide guidance on application and registration issues. Furthermore, a special government liaison will be appointed for the applicant, cementing formal channels of communication.
The applicant must fulfil certain conditions order to qualify for this process. First, the applicant must be a legal entity in China, which includes Sino-foreign joint ventures and WFOEs. The applicant also must have a valid manufacturing license for medical devices. Furthermore, the intellectual property must be owned in China by the applicant.
Of course, the device itself must also qualify for this fast track approval procedure. The innovative device must be manufactured in China. The device must be the first of its kind functionally in China, and must provide a significant improvement in safety or efficacy when compared with the currently available therapies. The device also needs to have strong clinical application value. Finally, the device must have already gone through the initial R&D stages and a basic prototype must already be developed.