What is China's risk based classification and administration for medical devices?

The classification regime for medical devices in China differs significantly from those in the European Union and United States. For example, a device considered to be Class II in the U.S. or Class II-a/II-b in the E.U. may be considered Class III in China, meaning its registration process will take longer and be more costly.

Basically, medical device classification in China is determined according to CFDA Order No. 15 (under revision) and other CFDA documents. While there are many factors related to classification, essentially devices are divided into three classes based on the risk they present to patients or users.