医疗器械生产标准有哪些分类和要求？-医疗事故法律援助-法律咨询免费平台-国际律师联盟

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问题	医疗器械生产标准有哪些分类和要求？
释义	法律分析：医疗器械生产需要按照相关标准进行，国家对医疗器械产品进行分类管理，根据风险等级划分为三类，具体标准要求也有所不同。其中，高风险医疗器械需要进行严格的设计和制造流程控制，相关环境设施要求也较为苛刻。同时，厂商还需要保证医疗器械的性能、安全、有效性等方面符合要求，以确保使用者的健康和安全。法律依据： 1.《医疗器械监督管理条例》第十一条、第十二条 2.《医疗器械产品分类目录》 3.《医疗器械注册管理办法》第十八条、第二十二条
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