经营第一类医疗器械和第二类医疗器械都需要备案对么？-法律综合法律援助-法律咨询免费平台-国际律师联盟

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问题	经营第一类医疗器械和第二类医疗器械都需要备案对么？
释义	不需要。根据新的医疗器械经营监督管理办法，第三条“第一类医疗器械的经营不需许可和备案；第二类医疗器械的经营实行备案管理；第三类医疗器械的经营实行许可管理。”所以只经营地一类医疗器械是无需备案的；生产第一类医疗器械是需要备案的。法律依据：《医疗器械监督管理条例》第五条医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。
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