北京平谷区材料医疗器械三类经营许可证，医疗器械二类备案办理提供人员品质优良

第三类医疗器械有哪些?

用于植入人体或支持维持生命，对人体具有潜在危险，对其安全性、有效性必须严格控制的医疗器械。如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、200mA以上X线机、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。

到工商局办理营业执照，注册为企业，可以是法人企业、非法人企业、个人独资企业、合伙制企业等，个体工商户不可以办理备安凭证，

(二)、到质监局办理组织机构代码证，

(三)、后列国 家食品药品监督管理总局网站用组织机构代码注册一个帐号，网上申报。

(四)、网上申报《医疗器械备案申请表》需要提交的电子材料，其中加"为必高项，

Where there are errors in the applicationmaterials that can be corrected on the spot, The applicant shall beallowed to make corrections on the spot; if the applicationmaterials are incomplete or do not conform to the statutory form,Should inform the applicant on the spot or within five days of allthe contents to be corrected, Failure to inform you after the timelimit, It shall be accepted from the date of receipt of theapplication materials; The matters to apply for fall within thescope of the functions and powers of the administrative organ, Theapplication materials are complete and in line with the legal form,Or where the applicant submits all the supplementary and correctedapplication materials as required by the respective administrativeorgan, The application for administrative license shall beaccepted.