医疗器械注册人制度试点工作概况及相关思考

Overview of the Pilot Program of Medical Device MAH System and Relevant Considerations

医疗器械注册人、备案人制度是新修订《医疗器械监督管理条例》设立的一项重要监管制度。本文概括了医疗器械注册人制度试点工作开展的过程,总结了试点工作的特点和取得的初步成效。在此基础上,提出了医疗器械注册人制度实施过程中在注册人和备案人全生命周期质量管理、委托方和受托方权责划分、监管职责划分等方面的思考。为下一步推进医疗器械注册人制度全面实施提出了建议。

The medical device MAH system is an important regulatory system set up in the newly-revised Regulations on the Supervision and Administration of Medical Devices.This paper summarizes the process and characteristics of the medical device MAH pilot program and the preliminary results achieved.On this basis,this paper offers analysis of the MAH’s responsibilities for lifecycle quality management,the division of rights and responsibilities between the MAH and the contract manufacturer,and the division of regulatory responsibilities among regulators at different levels during the implementation process of the medical device MAH system.Some suggestions are put forward to further promote the full implementation of medical device MAH system.