China Introduces New Medical Device Regulations

The Chinese State Council has approved new medical device regulations that will go into effect on June 1, 2021.

Under the new regulations, conditional approvals will be available for devices treating rare diseases or critical diseases for which there are no effective treatments.

China’s National Medical Products Administration will allow “versatile” clinical evidence to demonstrate safety and effectiveness, according to attorneys at the law firm Ropes & Gray. The clinical evidence can be based on clinical trial data or analysis of clinical literature and clinical data on predicate devices.