A draft regarding the handling of medical-device recalls says Chinese authorities can revoke licenses of producers of unqualified medical products. The government has authority to assign compulsory recalls and penalties equivalent to three times the medical device's value to manufacturers that do not voluntarily recall products with potential safety hazards.

According to new rules, medical-device producers should record the details on the handling of recalled products and report to the regulator of food and drugs. When destroying unqualified medical devices, producers are required to have a representative from the Ministry of Health witness the event. Furthermore, manufacturers should closely track and handle recalled embedded medical devices and bear relevant expenses resulting from the process. The regulations have been drafted by the State Food and Drug Administration, which was just incorporated into the Ministry of Health at a recent annual session of the National People's Congress.