CFDA proposes fast track reviews for breakthrough technologies and clinical priority areas

CFDA proposes fast track reviews for breakthrough technologies and clinical priority areas Brandwood Biomedical Global Medical Device and IVD Regulatory Services

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.

Priorities

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
  • cancer
  • 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

Process

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.

Links:

The CFDA announcement and call for comments (Mandarin)

English version (Google Translate)

Articles on China and Innovative Device Pathway


Help button-Quick Call-Brandwood BiomedicalWant to tackle the China market and need help with CFDA?  We have our own offices and team in Beijing and have Mandarin speaking regulatory experts in our Sydney office.  Contact us now to see how we can help you with China regulatory approvals.

Contact us, drop us an Email [email protected] or call Grant Bennett  on +61 2 9906 2984 (Sydney) or  Steven Wen on + 86 10 8532 5809 (Beijing).

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