Annual Report on Adverse Event Monitoring of Medical Devices in China in 2021

I．In 2021, the National Medical Device Adverse Event Monitoring Information System received more than 650000 medical device adverse event reports, and the average number of reports per million population was 461. The county-level coverage of adverse event reports of medical devices in 28 provinces (autonomous regions and municipalities directly under the central government) reached 100%. The number of grassroots registered users of medical device adverse event monitoring information system continue to increase, reaching more than 370000, including 29436 medical device registrants.

II．General situation of annual report

i．Number of adverse events of medical devices reported nationwide. In 2021, the National Medical Device Adverse Event Monitoring Information System received 650695 reports of medical device adverse events, an increase of 21.39% over the previous year..

ii.Average number of reports per million population. In 2021, the average number of adverse event reports of medical devices per million population in China was 461, an increase of 14.68% over the previous year .

III.Statistical analysis of adverse event reports of medical devices in ChinaStatistical analysis by report source

i. In 2021, among the adverse event reports of medical devices received by the National Adverse Drug Reaction Monitoring Center, the user reported 562928, accounting for 86.52% of the total reports; 14853 registrants reported, accounting for 2.28% of the total number of reports; 72567 reports were submitted by operating enterprises, accounting for 11.15% of the total reports; 347 reports from other sources, accounting for 0.05% of the total .

ii .Statistical analysis according to the injury degree of the incident

In 2021, among the medical device adverse event reports received by the National Adverse Drug Reaction Monitoring Center, 163 reports with injury degree of death, accounting for 0.03% of the total reports; there were 613,922 reports of other injuries, accounting for 94.35% of the total number of reports . For adverse event reports where the degree of injury is death, the National Center for Adverse Drug Reaction Monitoring urges the registrant to conduct investigation, evaluation, and timely disposal. In the report that has completed the analysis and evaluation, no clear correlation has been found between the adverse event and the medical device involved, and the follow-up monitoring has not found that the above event involves an abnormal increase in the risk of the product.

iii. Statistical analysis by medical device management category

In 2021, the vast majority of medical device adverse event reports received by the National Center for Adverse Drug Reaction Monitoring involved Class III and Class II medical devices. Among them, there were 224,287 reports involving Class III medical devices, accounting for 34.47% of the total number of reports; 305,645 reports involving Class II medical devices, accounting for 46.97% of the total number of reports; and 57,108 reports involving Class I medical devices, accounting for 57,108 reports of the total number of reports. 8.78%; 63,655 reports did not fill in the medical device management category, accounting for 9.78% of the total number of reports.

iv．Statistical analysis according to the classified catalogue of medical devices

In 2021, the medical device adverse event reports received by the National Medical Device Adverse Event Monitoring Information System involved all categories in the medical device classification catalog.

v.Statistical analysis by structural characteristics of medical devices

In 2021, among the medical device adverse event reports received by the National Center for Adverse Drug Reaction Monitoring, there are 423,018 reports involving passive medical devices, accounting for 65.01% of the total number of reports; 159,212 reports involving active medical devices, accounting for 159,212 reports of the total number of reports. 24.47%; 4,794 reports involving in vitro diagnostic reagents, accounting for 0.74% of the total number of reports; 63,671 reports without filling in the structural characteristics of medical devices, accounting for 9.78% of the total number of reports.

vi．Statistical analysis by actual use site

In 2021, among the medical device adverse event reports received by the National Center for Adverse Drug Reaction Monitoring, there were  569,693 reports using “medical institutions”, accounting for 87.55% of the total number of reports; 67,369 reports using “households”, accounting for 10.35% of the total number of reports; 13,633 reports were used as “other”, accounting for 2.10% of the total number of reports.

VII. ——The report of medical device adverse events may be one-sided and limited

i．Like most countries, medical device adverse event reports in China are collected and entered into the database through a spontaneous reporting system, that is, when an event is suspected to be related to a medical device, it can be reported. Affected by the reporter’s subjective consciousness, experience level, cognition level, and even the position held, the report of medical device adverse events may be one-sided and limited, such as inaccurate judgment of injury degree, irregular report filling, incomplete information, etc., and even events unrelated to medical devices are also reported as adverse events, so the statistical results deviate from the actual medical device adverse events.

ii. The number of adverse event reports of different medical devices is affected by many factors such as the number of use, risk degree and reporting awareness. Therefore, the number of adverse event reports does not directly represent the incidence or risk severity of medical devices.

iii．The above statistical data are from the data received from January 1, 2021 to December 31, 2021 in the National Medical Device Adverse Event Monitoring Information System. Due to the rounding rules, the sum of percentages may not be equal to 100%.

iv．When this year’s report is completed, some serious injury medical device adverse event reports were still in the process of investigation and evaluation. Therefore, the statistical results are a true reflection of the data collection at the time of statistics, and do not represent the final conclusion of medical device safety evaluation.

Excerpt from: National Center for Adverse Drug Reaction Monitoring

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