China institutes new medical device label requirements

Starting January 1, China began requiring detailed labelling and descriptions in Chinese on most medical device products sold in the country.

The new regulations from China’s National Medical Products Administration, the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland, apply to all Class I, Class II, and Class III device manufactured after January 1.

The regulations mandate using simplified Chinese characters for the device name and descriptions and ensuring that label descriptions correspond precisely to the description on the product registration.