EMERGO SUMMARY OF KEY POINTS:

• The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017.
• The program is open to Class III devices manufactured in China as well as Class II and III devices from foreign manufacturers.
• Chinese market registrants must apply for priority review qualification as part of their CFDA registration submissions.

Chinese medical device market regulators have finalized rules for their priority evaluation program for devices targeting certain populations and diseases, with an implementation date planned for January 1, 2017.

The China Food and Drug Administration’s (CFDA) final version (link in Chinese) of the rule applies to Class III devices manufactured in China as well as Class II and III imported devices.

Which devices qualify for CFDA priority review?

The types of medical devices that may qualify for CFDA priority evaluation are organized broadly into three groups:

• Group 1
  
  • Devices that diagnose or treat rare disorders and provide significant clinical advantage
  • Devices to diagnose or treat malignant tumors and provide significant clinical advantage
  • Devices to diagnose or treat diseases affecting elderly populations and that do not currently have effective diagnosis or treatment options
  • Devices to treat children and that provide significant clinical advantage
  • Devices that currently have no predicate products in China and that are urgently needed for public health purposes
• Group 2
  
  • Devices that fall under the National Science and Technology Major Project or the National Key Technologies R&D Program
• Group 3
  
  • Other devices for which high-priority evaluation is deemed necessary

Applying for CFDA priority evaluation

Chinese medical device market registrants interested in the priority evaluation pathway should include priority review applications and supporting documentation in their registration dossier submissions to the CFDA.

The CFDA’s Center for Medical Device Evaluation (CMDE) will review applications to determine which devices qualify for priority evaluation. For Group 1 devices, regulators will convene monthly meetings of expert panelists to make qualification decisions. Group 2 devices will undergo reviews lasting five business days.

Qualifying applications will be placed in queue for high-priority evaluation separate from standard registration reviews.  Although no set timelines have been given for priority versus standard CFDA reviews, shorter queue times as well as more active communication between CFDA staff and registrants in the priority evaluation program should result in shorter times to market.

More information on registration and market authorization timeframes can be found in our regulatory process chart.