| 李晓,张欣涛,郝擎,朱炯.国家医疗器械抽检质量安全风险管控方式分析[J].中国药事,2022,36(11):1229-1233 |
| 国家医疗器械抽检质量安全风险管控方式分析 |
| Analysis on the Control Methods of Quality and Safety Risk of National Medical Device Supervision and Inspection |
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| DOI：10.16153/j.1002-7777.2022.11.003 |
| 中文关键词: 医疗器械 抽检 风险管控 |
| 英文关键词: medical device supervision and inspection risk control |
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| 中文摘要: |
| 目的：分析国家医疗器械抽检质量安全风险管控方式，提出完善建议，以达到更加严密控制风险，保障公众用械安全，促进行业健康发展的目的。方法：梳理美国、欧盟、日本的医疗器械监管政策，并与我国医疗器械监管政策进行对比，归纳国家医疗器械抽检质量安全风险管控手段。结果与结论：美欧日均未明确提出医疗器械抽检的概念及实施手段，且其实行的医疗器械检查、检验、结果评估、召回等措施的全面性和针对性不及我国医疗器械抽检政策的实施力度。国家医疗器械抽检作为我国医疗器械上市后监管重要手段之一，其质量安全风险管控方式包括重大质量安全风险提示、监督抽检不合格产品及时处置、风险监测抽检结果提示及时处置、产品潜在风险点汇编转达以及各抽检品种质量分析报告编制。这些管控方式涵盖了抽检产品检验和分析所发现的绝大多数质量安全风险，为不同环节、 不同地区医疗器械监管工作提供技术支撑。对于目前存在的部分医疗器械注册人、备案人缺乏质量管理意识，部分监管部门抽检结果处理不及时的问题提出改善建议：一是建议医疗器械注册人、备案人夯实主体责任，规范风险管控行为；二是建议监管部门进一步落实注册人义务，提高监管效能。 |
| 英文摘要: |
| Objective: To sort out the control methods of quality and safety risk of national medical device sampling inspection, and put forward suggestions for improvement, so as to achieve the purpose of tightening risk control, ensure the safe use of medical device and promote the healthy development of the industry. Methods: The medical device regulatory policies of the United States, the European Union and Japan were sorted out, and compared with Chinese medical device regulatory policies. The control methods of quality and safety risk of national medical device supervision and inspection were summarized. Results and Conclusion: The United States, the European Union and Japan have not clearly put forward the concept and implementation means of medical device supervision and inspection. Moreover, its implementation of the inspection, the test, result evaluation, recall and other measures was less than the implementation of national medical device supervision and inspection policy in China. As one of the important means of post market supervision of medical devices in China, the national medical device supervision and inspection has the following quality and safety risk control methods: the prompting of major quality and safety risks, the timely disposition of unqualified products in supervision and inspection, the prompting and timely disposition of risk monitoring supervision and inspection results, the compilation and transmission of potential risks of products, and the compilation quality analysis reports of various samples. These control methods cover the vast majority of quality and safety risks found in the inspection and analysis of sampling products, which provide technical support for medical device supervision in different line and different regions. At present, some medical device registrants and recorders lack quality management awareness, and some regulatory authorities don’t handle the inspection results in time. The suggestions for solving these problems are put forward. Firstly, it is suggested that medical device registrants and recorders consolidate their main responsibilities and standardize risk control behaviors. Secondly, it is suggested that the regulatory authorities should further implement the obligations of registrants, and improve the regulatory efficiency. |
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