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我国根据医疗器械的预期用途、结构特征、使用方式等可能对人体产生的风险,将其分为三类。对于风险最低的第一类医疗器械生产实行备案管理,企业只需进行书面告知,准入门槛较低。2011年上半年上海市食品药品监督管理局宝山分局组织力量对全区22家一类医疗器械生产企业进行了全覆盖的专项检查。检查发现部分一类医疗器械生产企业的生产条件与其提交告知的申报材料不一致,检验能力未完全达到注册产品标准所规定的要求,存在一定的安全隐患。本文从案例分析入手,探讨了加强第一类医疗器械监管的紧迫性,并从第一类医疗器械注册审批和体系考核等方面提出了针对性的对策和建议,希望能为解决新时期下公众日益增长的医疗器械安全需求探索一条新的路径。
Our country according to the intended use of medical equipment, structural characteristics, the use of such methods may pose risks to the human body, it will be divided into three categories. For the lowest risk of the first type of medical equipment manufacturing record management, companies only need to inform in writing, access to a lower threshold. In the first half of 2011, Baoshan branch of Shanghai Food and Drug Administration organized the special inspection of all 22 categories of medical device manufacturers in the region. Inspection found that some types of medical equipment manufacturing enterprises production conditions submitted to inform the inconsistent with the application materials, inspection capabilities do not fully meet the requirements of the registered product standards, there are some potential safety issues. This article starts with a case study and explores the urgency of strengthening the supervision of the first type of medical devices and puts forward some countermeasures and suggestions on the first type of medical device registration approval and system assessment. Exploring a new path to the growing demand for medical device safety.