Medical device manufacturers with products in China should check their current product portfolios against a new device catalogue released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified.
The revised version (“New Catalogue”), which will become effective on Aug. 1, 2018, updates the device classification significantly and will have considerable impact on device registration, manufacturing and distribution, law firm Ropes & Gray, Shanghai, wrote in a note to clients.
Devices in China are divided into three regulatory classes based on the identified risks associated with the devices, with highest risk devices classified as Class III.
Devicemakers will need to figure out the class of their devices by using the classification catalogue, CFDA’s device classification notices, and classification rules for devices issued by CFDA in 2015. Devicemakers should also submit device classification applications to seek classification determination opinions for any new devices not covered by the catalogue or notices, Ropes & Gray said.