On 13.08.2018, the Chinese NMPA released the “Measures for Monitoring and Reassessing Adverse Events of Medical Devices” (NMPA Decree No. 1), which will take effect on 01.01.2019. The main purpose of this new regulation is to strengthen the post-marketing supervisions, such as monitoring of medical device adverse events and re-evaluation of the approved medical devices.
It also clarifies the responsibilities of NMPA Legal Agents and medical device manufacturers. According to the new regulation, the manufacturer shall conduct continuous research on the medical devices that are already approved in order to evaluate risks and monitor adverse events. The regulation also lists penalties in case the manufacturer fails to comply with the regulation.
