Take Advantage of CFDA’s Priority Channel For Your Medical Device

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As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA opened up its priority review and approval procedure for medical devices on January 1st, 2017.

CFDA Priority Review Policy

Now applicants with a Class II device (limited to imported application) or a Class III device (both domestic and imported application) to request CFDA for a priority review if the device has been enrolled in

  1. National Science and Technology Major Project, or
  2. National Key Research and Development Plan, or
  3. If it can diagnose and treat:
  • Rare diseases, and has significant advantages in clinical practice
  • Malignant tumors, and has significant advantages in clinical practice
  • Specific and frequently occurring diseases in the elderly, and where there is no Effective way to diagnose or cure such diseases
  • Specific and frequently occurring pediatric diseases, and where there is no other effective treatment
  • Or can address an urgent clinical need, and the same type of device has not yet been marketed in China

 

CFDA Priority Review Process

In China, Class II and Class III devices start with a technical review process with the CFDA’s Center for Device Evaluation. That review first assesses whether a device will be qualified for priority review. For those device applications that receive the priority review designation, companies will be eligible to take advantage of several features, including frequent interactions with the technical review team.

When meeting the priority criteria, today there are several expedited processes for your device. CFDA controls an accelerated approval for devices applicable to emergency public health incidents and a fast track approval for innovative devices.

CFDA Priority Review Evaluation and Execution

Contact China Med Device team today. Our experience team will work with you to assess your device’s CFDA priority review qualification and accelerate your device’s entry into China.

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