天津市医疗器械生产监督管理办法实施细则.doc

天津市医疗器械生产监督管理办法实施细则
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities36
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities36
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
所在地天津市食品食品药品监督管理局分局书面告知登记。第一类生产企业登记时应提交以下材料：
（一）工商行政管理部门部门颁发的营业执照或副本原件和复印件；
（二）生产场地证明文件原件和复印件(（如产权证书、租赁合同/协议等）；
（三）拟生产产品及主要生产设备和检验设备明细清单；
（四）拟生产无菌医疗器械的应提供有资质检测机构出具的一年内的洁净室检测合格报告；
（五）申办企业对所报送申办材料真实性的自我保证声明一份。
（六）第一类生产企业整个医疗器械产品全部委托另一企业制造完成的，申办企业应报送企业与被委托企业双方的生产协议、质量协议，被委托企业应符合《医疗器械生产监督管理办法》有关规定。
第八条 开办第二类生产企业应符合下列条件：
（一）开办第二类生产企业应符合《医疗器械生产监督管理办法》第七条规定；
（二）生产企业生产骨科植入物、医用X线设备的，其生产场地不小于400平方米（不含办公区）；生产医疗设备、手术器械类等产品的，生产场地不小于200平方米；生产其他医疗器械等产品的，生产环境应整洁，其生产场地不小于100平方米（不含办公区）；生产一次性使用医用材料、敷料、体外诊断试剂等产品的，应具有空气洁净度不低于30万级净化车间，其净化面积不小于60平方米（国家另有规定的除外）；
of rural drinking water sources, protection of drinking water sources in rural areas by the end of t