In late October 2016, ARQon meeting with CFDA on the exchange sharing of fast track authorization route in Singapore and the Green channel fast track route with its latest updates in China. From 1 January 2017, CFDA put into effect, another priority approval procedure ‘Priority to the examination and approval of medical device applications’.
CFDA will give priority to the examination and approval of applications for the registration of domestic Class III device and imported Class II and Class III medical devices that meet one of the following conditions:
For medical device under item (1) and (2) above, the applicant would have to submit the application for priority examination and approval to the CFDA.
For medical devices under item (3) above, the CFDA will listen to opinions extensively and organize experts review to determine the approval.
Decision will be made in monthly expert review, and for item (2) will be in 5 working days.
CFDA will accelerate the review and approval for device under priority approval application by:
Giving priority for conducting technical review,
Giving priority to arrange medical device registration quality management system verification,
Giving priority to conduct administrative approval
This in turn will shorten time to market the device, and thus the device can be used as soon as possible in clinical use.
The new process also mentioned that CFDA will provide the opinion and reason if any rejection result, and also allows opposition to the result within the public notice period.
This priority approval procedure, is an addition to the previous 2009 and 2014 priority approval procedures, namely ‘Medical Device Emergency approval procedure’ and ‘Special approval procedures for innovative medical devices’.
To recap, ‘Medical Device Emergency approval procedure’ criterias include:
To recap, ‘Special approval procedures for innovative medical devices’, criterias include to meet all the following:
Click here (link in Chinese) for more information on the priority approval procedures by CFDA.