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医疗器械资质办理流程

1.申请医疗器械生产许可证:申请者需向国家食品药品监管部门提交材料,经过审核,如符合相关要求,会向申请者发放生产许可证。

2.申请医疗器械注册证:在拥有医疗器械生产许可证后,申请者需要向国家食品药品监管部门提交医疗器械注册申请材料,如通过审核,会颁发医疗器械注册证书。

3.申请医疗器械市场许可证:拥有医疗器械注册证后,申请者需要向所在区或市的食品药品监管部门申请市场许可证,如通过审核,会颁发市场许可证。

4.缴纳相关费用:在获得各类许可证后,需要向相关机构缴纳相应的证书费用和资料认证费用。

5.领取证书:缴纳证书费用后,即可领取医疗器械生产许可证、医疗器械注册证和市场许可证,正式开始运营。

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发布时间:2025-01-22
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