Healthcare, Industry News, Medical Devices, Regulatory Affairs

China FDA finalized the rules for priority on review program for some medical devices

The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017.

The CFDA’s final guidelineof the rule is open to Class III medical devices manufactured in China and Class II and III devices imported from foreign manufacturers.

Chinese market registrants must apply for priority review qualification as part of their CFDA registration submissions.

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

  1. Group:1
  2. Devices that diagnose or treat rare disorders and provide significant clinical advantage
  3. Devices to diagnose or treat malignant tumors and provide significant clinical advantage
  4. Devices to diagnose or treat diseases affecting elderly populations and that do not currently have effective diagnosis or treatment options
  5. Devices to treat children and that provide significant clinical advantage
  6. Devices that currently have no predicate products in China and that are urgently needed for public health purposes
  7. Group:2
  8. Devices that fall under the National Science and Technology Major Project or the National Key Technologies R&D Program
  9. Group:3

Other devices for which high-priority evaluation is deemed necessary.

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