China: Stricter rules on recalls of medical devices

The Chinese Food and Drug Administration has adopted new rules on medical device recalls in China. The new rules expand the scope of products in recalls which means that more types of products are seen as defect and are subject of mandatory recall. According to the official government press release, there are three levels for recall in accordance with the seriousness of the defect. Additionally, the new rules increase significantly the maximum penalty for failure to recall of a device.

The new law is coming into effect on May 1, 2017.

The official press release: China issues rules on recall of defective medical equipment.