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CFDA to Reform Medical Device Regulations in 2017 (November 2016)

China Food and Drug Administration (CFDA) is announcing that it will begin accepting priority review applications for medical devices in January 2017. The priority review procedure is a new component intended to enhance the approval system for drugs and devices.

Under new regulations, companies can submit requests for priority review with the device applications for both Class II and III devices if they meet certain criteria:

  1. Devices part of China’s National Science and Technology Major Project or the National Key Technologies and Design Program.
  2. Devices that can diagnose and treat:
    • Rare diseases
    • Malignant tumors
    • Specific and frequently occurring diseases in the elderly, where other treatment options are limited or nonexistent
    • Specific and frequently occurring pediatric diseases, where other treatment options are limited or nonexistent
    • Urgent clinical needs, where the same type of device has not been marketed in China

 

Process for Priority Review

Before a device can be marketed in China, the Center for Device Evaluation under the CFDA must review them to identify those eligible for priority review. The process is as illustrated:

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