• Overall Situation of National Annual Report for Medical Device Adverse Events

In 2020, the National Medical Device Adverse Event Monitoring Information System has received a total of 536,055 reports of medical device adverse events, showing an increase of 35.25% compared with the previous year.

In 2020, the average number of medical device adverse event reports per million population in China was 402, showing an increase of 35.35% compared with the previous year.

As of December 31, 2020, there were a total of 350,973 grassroots users (incl. registrants, distributors and using units) registered in the National Medical Device Adverse Event Monitoring Information System, covering 27,195 registrants (7.75%); 198,833 distributors (56.65%); and 124,945 using units (35.60%).

In 2020, the total number of registered grassroots users increased by 10.03% compared with the previous year. Among them, the registered grassroots users of registrants, distributors and using units have increased by 38.31%, 11.52% and 3.24% compared with the previous year, respectively.

• Statistical Analysis of National Medical Device Adverse Event Reports

(I) Statistical analysis according to the sources of reports

In 2020, among the medical device adverse event reports received by the National Center for ADR Monitoring, 455,782 (85.03%) were reported by using units, 11,191 (2.09%) were reported by registrants, 68,902 (12.85%) were reported by distributors, and 180 (0.03%) reports were from other sources.

(II) Statistical analysis according to the extent of injury of events

In 2020, among the medical device adverse event reports received by the National Center for ADR Monitoring, there were 218 (0.04%) reports of death, 32,874 (6.13%) reports of severe injury, and 502,963 (93.83%) reports of other injuries.

In 2020, for the medical device adverse event reports of death, the National Center for ADR Monitoring has timely took measures and urged registrants to carry out investigation and evaluation. Most of the events that have been analyzed and evaluated currently showed no clear correlation with medical devices involved. In the follow-up monitoring, no abnormal increase in the risks of medical devices involved in the above events was identified.

(III) Statistical analysis according to the management categories of medical devices

In 2020, among the medical device adverse event reports received by the National Center for ADR Monitoring, there were 178,305 (33.26%) reports involving Class III medical devices, 242,457 (45.23%) reports involving Class II medical devices, 46,995 (8.77%) reports involving Class I medical devices, and 68,298 (12.74%) reports indicating no management categories of medical devices.

(IV) Statistical analysis according to the Medical Device Classification Catalogue

In 2020, medical device adverse event reports received by the National Medical Device Adverse Event Monitoring Information System involved all categories in the Medical Device Classification Catalogue.

(V) Statistical analysis according to the structural characteristics of medical devices

In 2020, among the medical device adverse event reports received by the National Center for ADR Monitoring, there were 345,326 (64.42%) reports involving non-active medical devices, 118,730 (22.15%) reports involving active medical devices, 3,672 (0.69%) reports involving in vitro diagnostic reagents, and 68,327 (12.75%) reports indicating no structural characteristics of medical devices.

(VI) Statistical analysis according to the actual service site

In 2020, among the medical device adverse event reports received by the National Center for ADR Monitoring, in terms of service site, there were 459,553 (85.73%) reports showing "Medical institutions", 64,109 (11.96%) reports showing "Household", and 12,393 (2.31%) reports showing "Others".