China’s SFDA Tightens Control over Labeling of Imported Medical Devices

The State Food and Drug Administration (SFDA) of China requires all imported medical devices to bear labels in Chinese before entering China. If a foreign medical device does not have Chinese on its label, it will not be allowed to enter China. The labels can also be written in other languages, in addition to Chinese.

This language requirement for medical device labels is not new. It has been effective since 2004. However, under the new proposal of the SFDA, Chinese labels must be affixed to medical devices before entering any Chinese territories. Currently, foreign device manufacturers may ship their products to a bonded zone in China, such as Waigaoqiao in Shanghai or Yantian in the southern coastal city of Shenzhen. There, they may attach Chinese labels to their products before shipping them to other parts of China. However, under the new regulation, the labels must be already written in Chinese before they can be approved for import to China.

The SFDA stresses that packaging and labeling are essential components of the manufacturing process. Accordingly, they should be effectively controlled and comply with all regulations issued by the SFDA.