China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017.
The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices.
According to the law firm Ropes & Gray, the new policy, first drafted in June, will allow applicants with a Class II device (limited to imported application) or a Class III device (both domestic and imported application) to request a priority review if the device (i) has been enrolled in the National Science and Technology Major Project or National Key Research and Development Plan, or 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
Process for Priority Review
Prior to a device being marketed in China, Class II and Class III devices must go through a technical review process conducted by the Center for Device Evaluation under the CFDA or at the provincial level.
That review assesses whether a device is eligible for priority review, and a decision on the priority review designation will be made before the technical review process begins.
For any application that passes the initial eligibility review, an outside third party may submit an opposition to challenge the result during the public notification period.
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.
Ropes & Gray also notes that CFDA has already developed two expedited approval processes for devices, including an accelerated approval for devices applicable to emergency public health incidents and a fast track approval for innovative devices.
In addition to the priority reviews, CFDA is also undergoing a major shift in policy on device quality and clinical trials.
Meanwhile, the fast-track scheme for pharmaceuticals is intended to target and prioritize new treatments for cancer, rare diseases, AIDS, tuberculosis and viral hepatitis, as well as those aimed at pediatric and elderly patients.