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National Annual Report for Medical Device Adverse Event Monitoring (2020) 国家医疗器械不良事件监测年度报告（2020年）
Overall Situation of National Annual Report for Medical Device Adverse Events 全国医疗器械不良事件年度报告总体情况
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. 2020年，国家医疗器械不良事件监测信息系统共收到医疗器械不良事件报告536,055份，比上年增加35.25%。
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. 2020年，我国每百万人口平均医疗器械不良事件报告数为402份，比上年增加35.35%。
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%). 截至2020年12月31日，在国家医疗器械不良事件监测信息系统中注册的基层用户（包括注册人、经营企业和使用单位）共 350,973家，其中注册人27,195家，占用户总数的7.75%；经营企业198,833家，占用户总数的56.65%；使用单位124,945家，占用户总数的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. 2020年，注册基层用户总数比上年增长10.03%。其中，注册人注册基层用户比上年增长38.31%，经营企业和使用单位的注册基层用户分别比上年增长11.52%和3.24%
Statistical Analysis of National Medical Device Adverse Event Reports 全国医疗器械不良事件报告统计分析
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. 2020年，国家药品不良反应监测中心收到的医疗器械不良事件报告中，使用单位上报455,782份，占报告总数的85.03%；注册人上报11,191份，占报告总数的2.09%；经营企业上报68,902份，占报告总数的12.85%；其他来源的报告180份，占报告总数的0.03%。
按事件伤害程度统计分析 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. 2020年，国家药品不良反应监测中心收到的医疗器械不良事件报告中，伤害程度为死亡的报告218份，占报告总数的0.04%；伤害程度为严重伤害的报告32,874份，占报告总数的6.13%；伤害程度为其他的报告502,963份，占报告总数的93.83%。
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. 2020年，对于事件伤害程度为死亡的医疗器械不良事件报告，国家药品不良反应监测中心均及时进行了处置，督促注册人 开展调查、评价。在目前完成分析评价的事件中，绝大多数与涉及医疗器械无明确相关性。后续监测中，尚未发现上述事件涉及医疗器械风险异常增高情况。
按医疗器械管理类别统计分析 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. 2020年，国家药品不良反应监测中心收到的医疗器械不良事件报告中，涉及Ⅲ类医疗器械的报告178,305份，占报告总数的33.26%；涉及Ⅱ类医疗器械的报告242,457份，占报告总数的45.23%；涉及Ⅰ类医疗器械的报告46,995份，占报告总数的8.77%；未填写医疗器械管理类别的报告68,298份,占报告总数的12.74%。
按医疗器械分类目录统计分析 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. 2020年，国家医疗器械不良事件监测信息系统收到的医疗器械不良事件报告涉及了医疗器械分类目录中的所有类别。
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. 2020年，国家药品不良反应监测中心收到的医疗器械不良事件报告中，涉及无源医疗器械的报告345,326份，占报告总数的64.42%；涉及有源医疗器械的报告118,730份，占报告总数的22.15%；涉及体外诊断试剂的报告3,672份，占报告总数的0.69%；未填写医疗器械结构特征的报告68,327份,占报告总数的12.75%
按实际使用场所统计分析 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". 2020年，国家药品不良反应监测中心收到的医疗器械不良事件报告中，使用场所为“医疗机构”的报告459,553份，占报告总 数的85.73%；使用场所为“家庭”的报告64,109份，占报告总数的11.96%；使用场所为“其他”的报告12,393份，占报告总数的 2.31%。
以上内容仅供学习参考，原文链接：中国食品药品国际交流中心 https://www.ccfdie.org/cn/dzqk/webinfo/2021/05/1622492393088175.htm
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