摘要
目的 :研究新形势下医疗器械检验报告要求,为推进医疗器械检验报告的改革顺利实施提供参考。方法 :采用文献研究和风险管理方法,研究了新形势下医疗器械检验报告要求提出的背景、对医疗器械监管带来的转变,并结合风险管理理论对该要求面临的挑战和风险进行了分析。结果与结论 :新形势下对医疗器械检验报告的要求是促进医疗器械产业发展的供给侧改革,其带来三个转变:对标国际规则、“检验报告和检验依据”双减,以及企业提供检验报告的路径从“被动单一”到“主动多元”。同时,该要求也面临配套文件、合规检验和合规监管三个挑战,存在产品设计验证和质量控制不充分、对检验报告核查的能力不全面、标准信息不对称三个风险。对此,本文提出三个建议:一是企业作为责任主体,要平衡好产品检验风险和企业检验能力;二是检查部门要提升质量管理体系中自检报告的检查能力;三是药品监管部门的审评、核查、检测和监测等工作要加强产品全生命周期监管的联动,形成风险控制的闭环控制。
Objective: This paper aims to study the requirements of medical device test report under new situation, thus providing reference for promoting the implementation of the reform of medical device test report in China. Methods: Based on literature research and risk management methods, this paper studies the background of medical device test report requirements under the new situation and the impact on medical device regulation, and analyzes the challenges and risks faced by this requirement based on risk management theory. Conclusions: Under the new situation, the requirement of medical device test report is to promote the development of the medical device industry, which brings three main changes:benchmarking to the international rules, the double reduction of "test report and test standard", and the transformation of the path to provide test report from "passive single" to "active multiple". At the same time, the reform also faces three challenges:supporting documents, compliance inspection and compliance supervision, which bring three risks—insufficient product design verification and quality control, incomplete ability to inspect test reports, and asymmetric standard information. To this end, this paper puts forward three suggestions: First, as the subject of responsibility, enterprises should balance the product test risk and ability;Second, the regulation authorities should improve the inspection ability of self-test report in the quality management system;Third, the review, inspection, testing and monitoring of regulatory departments should strengthen the linkage of supervision over the whole life cycle of products and form a closed-loop control of risks.
作者
李非
郭柏军
于滢
苑富强
LI Fei;GUO Bai-jun;YU Ying;YUAN Fu-qiang(Liaoning Medical Device Test Institute;National Institute for Food and Drug Control)
出处
《中国食品药品监管》
2022年第12期88-93,共6页
China Food & Drug Administration Magazine
关键词
医疗器械
自检
检验报告
供给侧改革
风险管理
medical device
self-test
test report
supply-side reform
risk management
