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【FDA注册】医疗器械FDA注册办理机构
近视眼镜出入口美国必须依照诊疗器械FDA注册开展申请办理,深圳市环测威第三方检测组织能够申请办理1类诊疗器械FDA注册及二类510KFDA注册。太阳眼镜,眼镜框,眼镜片和高倍放大镜是可免于递交给食品类和药物管理处(FDA)的发售前通告510(k)的医疗器械。尽管这种机器设备可免于510(k),但别的好多个FDA政策法规可用:1.美国生产商和最开始的美国代理商(采购商)务必在FDA注册;2.国外生产
2021/08/12

近视眼镜出入口美国必须依照诊疗器械FDA注册开展申请办理,深圳市环测威第三方检测组织能够申请办理1类诊疗器械FDA注册及二类510KFDA注册。太阳眼镜,眼镜框,眼镜片和高倍放大镜是可免于递交给食品类和药物管理处(FDA)的发售前通告510(k)的医疗器械。尽管这种机器设备可免于510(k),但别的好多个FDA政策法规可用:

1.美国生产商和最开始的美国代理商(采购商)务必在FDA注册;

2.国外生产商务必在FDA注册并取名为美国地区代理;

3.生产商务必在FDA上列举她们的机器设备;

4.生产商务必达到21 CFR 820中要求的质量管理体系(QS)规定。

5.依据21 CFR Part 801.410,用以近视眼镜和/或太阳眼镜的眼镜片务必具备抗震作用。

6.不遵循这种规定很有可能造成 机器设备被扣押在美国入关港口。

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美国FDA诊疗器械归类:

诊疗器械FDA注册I 类

这类器械执行一般操纵(General Control),指危险因素小或基本上无危险因素产品,比如手术手套、压舌板、手做手术器械、温度表等。

绝大多数I 类器械只需开展注册、产品备案和执行GMP标准,就可以进到美国销售市场(在其中极个别器械连GMP也免除,大概7%的I类器械应向FDA提交510(k)申请办理即PMN(Premarket Notification)。这种器械只需历经一般操纵就可以保证其作用与安全系数,如拐棍、眼镜镜片、胶带等。I 类器械约占所有医疗器械的27%。

这种操纵包含:严禁品质不过关及标识不合理产品的市场销售、务必向FDA汇报相关不良影响、维修、换置等事宜、限定一些器械的市场销售和应用、执行GMP标准。

诊疗器械FDA注册Ⅱ类

这类器械执行一般操纵   独特操纵(Special Control),指具备一定危险因素的产品,比如血氧仪、超声波检查仪、静脉注射打点滴器材、呼吸面罩等。

针对Ⅱ类器械,公司在开展注册和产品备案后,除开以上一般操纵以外,92%的II类器械规定开展发售前通知(PMN:Premarket Notification)(即510K)。小量的II类产品能够免除发售前通知程序流程。制造业企业须在产品发售前90天向FDA提交申请,根据510K核查后,产品才可以发售市场销售。II 类器械约占所有医疗器械的46%。

诊疗器械FDA注册Ⅲ类

这类器械执行一般操纵   发售前批准(Premarket Approval),指具备很大危险因素或不良影响,或用以适用、维护保养性命的产品,比如人力心脏瓣膜、心血管支架、晶状体、人工血管等。

针对Ⅲ类器械,公司在开展注册和产品备案后,须执行GMP并向FDA提交PMA申请办理,80%的III类器械必须510(K),20%的III类器械必须PMA申请办理。II 类器械约占所有医疗器械的7%。


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