The China Food and Drug Administration announced that manufacturers will be able to request priority review and approval of Class II (limited to imported application) and Class III (both domestic and imported application) devices exported to China beginning January 1, 2017. RAPS reported that the device must have 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
If you need help navigating the process for a priority review, please contact us. Pearl Pathways’ expert guidance can help you with your device applications and expedited approval if your device meets the CFDA’s fast-track approval requirements.