China – Medical device adverse event reports increase by 35% in China

China’s National Medical Products Administration (NMPA) has released new findings showing a substantial increase in the number of medical device adverse event reports for 2020.

According to the regulator’s Annual Report on the Monitoring of Adverse Events of Medical Devices (2020) (link in Chinese), the number of adverse event reports submitted to the National Medical Device Adverse Event Monitoring Information System last year increased by more than 35%, from 396,345 reports in 2019 to 536,055 reports in 2020.

Emergo by UL consultants in Beijing note NMPA’s recent improvements to its adverse event reporting system as well as guidance for adverse event monitoring (link in Chinese) issued in April 2020 as contributing factors for the marked increase in reporting…