引入第三方认证机构参与医疗器械上市后监管的思考与实践

Consideration and Practice of Introducing Third-party Certification Institutions to Participate in Post-marketing Supervision of Medical Devices

经过多年的国际监管实践,第三方认证机构已经成为医疗器械监管领域重要的社会力量。在我国的医疗器械监管法规体系下,如何引入社会资源在医疗器械监管活动中发挥积极作用,上海药品监管部门在第三方认证机构参与医疗器械上市后监管方面进行了初步实践和探索。该文从引入第三方认证机构参与监管的目的、切入点、检查标准和结果处理等方面进行了阐述,同时对下一步工作方向进行了展望。

After years of international regulatory practice,the third party certification bodies have become an important social force in the field of medical devices supervision.It is broadly discussed how to introduce social resources to play an active role in the supervision of medical devices under the regulatory system of medical devices in China.Shanghai Medical Products Administration has carried out research and preliminary practice on the participation of third-party institutions in post-marketing supervision of medical devices.The article mainly focuses on purpose,entry point,inspection criteria and result disposal of introducing the participation of third-party institutions in the post-marketing supervision,meanwhile,discusses the next work direction at the same time.