CFDA: Priority Review Procedure for Medical Devices24. August 2016
In China it is necessary that manufacturers of class II and class III medical devices follow a strict technical review. This technical review is done by the Centre for Medical Device Evaluation (CMDE). This is necessary before the devices can be shipped to China.
The priority review should give the applicants shorter review time in the registration process. According to the circular, applicants with class II medical devices (only foreign applicants) or class III medical device manufacturers (both domestic and foreign applicants) can request a priority review in some cases. First of all, a priority review is possible if the device is part of the National Science and Technology Major Project or the National Key Research and Development Plan. Priority review is also possible if a medical device can:
- diagnose or treat a rare disease and has outstanding advantages in clinical practice
- diagnose or treat malignant tumors and has outstanding advantages in clinical practice
- diagnose or treat a specific disease that frequently occurs in the elderly and there is no other effective way to diagnose or cure such disease
- diagnose or treat a specific disease that frequently occurs in children and there is no other effective way to diagnose or cure such disease
- address an urgent clinical need and the same type of device has not yet been marketed in China
The CMDE will decide whether a specific medical device is able to receive priority review. If a device is not eligible to receive priority review, they have to follow the standard review process. If a device receives priority review the applicant is able to make use of features which shorten the technical review process. As it can be seen, the CFDA is trying to introduce new approaches which can improve the registration process. Therefore, medical device manufacturers should monitor changes constantly.
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