Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified.
The revised catalog, effective on Aug. 1, 2018, will have considerable impact on device registration, manufacturing and distribution, according to attorneys at Ropes & Gray, Shanghai.
Devices in China are divided into three regulatory classes based on risk, with highest risk devices classified as Class III.
Devicemakers will need to figure out the class of their devices by using the classification catalog, CFDA’s device classification notices, and classification rules for devices issued by CFDA in 2015. Devicemakers should seek classification opinions for any new devices not covered by the catalog or CFDA’s device classification notices, Ropes & Gray said.
The new catalog is more comprehensive than the current version released in 2002. It reduces the number of device categories to 22 from the current 43, based on the functions and clinical uses of the devices. For each category, the new catalog contains primary type, sub-type, device description, intended use, device examples and classification.
The new catalog also reclassifies the current 260 device types into 206 primary types, and further subdivides the 206 primary types into 1,157 sub-types of products.
In addition, the revised catalog adds a detailed description of the device features and intended uses for each sub-type.
The revised catalog also includes 6,609 example devices in the device example column, while the 2002 catalog only listed 1,008 example devices.
The new version also down-classifies 40 devices to Class II (such as fully automated immunodiagnostic system, fully automated disposable biopsy needle) or Class I, and up-classifies certain types of devices to Class III, such as automated blood bank systems and active breathing devices.
The 2002 catalog has been criticized for not providing clear guidance to manufacturers seeking a classification decision. In particular, it doesn’t include product descriptions and intended uses for some categories of products. The categories also overlap, which can lead to inconsistent determinations.
The 2002 catalog is outdated and failed to keep up with the “rapid proliferation of medical devices and the growth of complex technologies that have taken place in China,” said Grace Fu Palma, founder and CEO of China Med Device.
The catalog has significant implications for medical devices registrations and renewals, Fu Palma said. In particular, if a device is not included in the catalog, a manufacturer must go through an expert panel forum to get it listed, which is time-consuming and costly. — Tamra Sami