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。
If we do medical devices, medical devices are divided into 3 categories, a class three categories, one is not care about the business scope directly write can operate, the second is the record system, general network or site is a record system, three is the examination and approval system, is to have the actual office addre