CFDA proposes fast track reviews for breakthrough technologies and clinical priority areas
China’s CFDA has published a draft procedure to prioritise the evaluation of certain medical device submissions, and is asking for industry comments by July 20, 2016.
CFDA proposes prioritising submissions for technologies which fall into national priority areas and for devices which address unmet clinical needs.
The proposed process lists several specific categories of devices targeted for favoured treatment:
Group 1 Technologies
This is for devices which use technologies or inventions which have been identified at State level as nationally important scientific R & D.
Group 2 Clinical Priorities
This is for specific areas of clinical practice where China sees unmet clinical need. priority is given to technologies with significant clinical advantage for treatment or diagnosis in the areas of:
- rare diseases
- geriatrics and paediatrics
- Any area of urgent unmet clinical need where there are no devices currently available in China.
Group 3 Others
This is a placeholder for other categores to be discussed and possibly added
The new process provides for the applicant to raise a prioritization request at the time of submission of the regulatory application to CFDA. The applicant must identify which priority categor(ies) into which the device or diagnostic fits.
In the case of Group 1 priority Technologies, the applicant must also submit the proof of State government prioritisation.
For group 1 cases CFDA intends to evaluate the prioritisation request within 5 working days after accepting the submission, then notify applicant the determination. For Group 2 CFDA proposes a monthly review panel to consider submissions and issue notifications after each panel meeting.
This new process is quite different from the innovative device pathway (“Green Channel”). The Innovative Device Pathway offers more than that – with specific technical and regulatory assistance to applicants, parallel classification reviews and a nominated internal champion to ensure smooth passage through the review. This new process is simpler: there’s no lengthy pre-qualification. Rather it’s simply a matter of making the request as part of a traditional regulatory submission – which if successful results in priority processing.
The CFDA announcement and call for comments (Mandarin)
English version (Google Translate)
Articles on China and Innovative Device Pathway
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