我国医疗器械注册人制度试点实施的风险分析及策略探讨

Risks in trial implementation of medical device marketing authorization holder system in China

目的为我国医疗器械注册人制度全面落地实施提供参考建议。方法通过对江苏省医疗器械注册人制度试点实施研究工作进行调研,分析该制度试行过程中可能存在的风险,并就应对策略进行探讨。结果该制度实施后可能存在多种风险,主要来源有注册人质量责任承担能力不足、注册人全生命周期风险管理能力欠缺、知识产权保护与委托生产难以平衡、受托生产企业落实生产责任不到位、跨区域委托生产监管难度增加等。结论建议应设立对注册人的资格准入条件,提高注册人的全生命周期风险管理能力,强化医疗器械知识产权保护意识,加强对受托生产企业的监督管理,建立跨区域协同合作的监管机制。

Objective To provide suggestion for the formal implementation of medical device marketing authorization holder system in China.Methods Through the research on the preparation for implementation of medical device marketing authorization holder system in Jiangsu Province,analyze the possible risks in the trial process and discussed the coping strategies.Results Multiple risks existed during the implementation process,including the registrants’insufficient ability to bear the responsibility,the registrant lacking of full life-cycle risk management capabilities,imbalance between intellectual property protection and commissioned production commissioned manufacturer’s weak ability to fulfill its production responsibility,and increased difficulty in supervision for cross-regional commissioned production etc.Conclusion Access requirement for registrants should be established,registrants’life-cycle risk management capabilities should be improved,awareness of intellectual property protection in medical devices should be strengthened,supervision and management of commissioned manufacturers should be reinforced,and regulatory mechanism for cross-regional collaboration should be established.