摘要
Abstract
Driven by the increasing demand for optimal allocation of medical resources,the medical device trade market in China has experienced continuous growth.Although current regulations do not explicitly prohibit the transfer of used medical devices,the absence of detailed regulatory rules and operational guidelines has created multiple practical challenges.These include ambiguous definitions of conformity documentation,lack of traceability throughout the transfer process,discrepancies between testing requirements and actual implementation,and insufficient standards for post-transfer maintenance.Such deficiencies may lead to legal risks and disputes involving civil,administrative,and even criminal liabilities.Moreover,the existing regulatory framework does not mandate the participation of key responsible entities(such as medical device registrants and filers)in the transfer process,further undermining the safety and quality assurance of devices after transfer.These institutional gaps not only hinder the progress of compliant transfers but also make it difficult to effectively regulate illegal transfer activities.In response,this paper proposes strengthening the regulatory framework governing the transfer of used medical devices by improving relevant legislation and regulatory mechanisms.Such improvements aim to effectively prevent and control the risks associated with the transfer of used medical devices and promote safer and more standardized market practices.关键词
已使用医疗器械/转让/维修/法律规范/风险控制Key words
used medical devices/transfer/maintenance/legal regulation/risk control分类
社会科学
