How to apply for a medical device license Class I, Class II, Class III, yes
Published on 2018-08-22
Article guide: You do not need to apply for a license to operate a class of medical devices, as long as you have a business registration. The operation of the second-class medical devices needs to be filed by the municipal bureau, and a filing certificate should be issued. The three types of medical devices need to be licensed and issued by the municipal bureau. From October 1, 2014, "Medical Devices ...
不用办证，只要有工商登记即可。 There is no need to apply for a license to operate a class of medical devices , as long as there is a business registration. 需要市局备案，发备案凭证。 The operation of the second-class medical devices needs to be filed by the municipal bureau, and a filing certificate should be issued. 需要市局许可，发许可证。 The three types of medical devices need to be licensed and issued by the municipal bureau. 必须网上申报 ，现场考核后通过。 From October 1, 2014, the "Medical Device Operating Permit" must be applied for online and passed after an on-site assessment. “网上办事”栏目中的“医疗器械生产经营许可备案信息系统”点击进入。 It can be accessed from the "Information System for Medical Device Production and Operation Permit" in the "Online Services" column on the homepage of the Food and Drug Administration's website . After entering the login page, there is a special operation manual and tutorial video download interface, which can be downloaded and used by applicants. When applying for registration of permits, in addition to completing the online declaration in the system, paper materials should also be submitted to the corresponding approval and filing department at the same time. Note: 1. If the business license is not an enterprise but an individual business owner, it is not allowed to apply for a medical device business license. 办理升级业务。 (Individual) business license can go to the Industry and Commerce Bureau for upgrading business. 管片的工商所登记、填表，然后拿着相关材料到政务大厅办理营业执照升级，升级为企业，然后办理组织机构代码证 ，然后到网上申报 。 The specific steps are: first register and fill in the form of the industrial and commercial office where the industry and commerce bureau manages the film, then take the relevant materials to the government affairs hall to upgrade the business license, upgrade to an enterprise, then apply for an organization code certificate , and then apply online . 需要提交的电子材料，其中加*为必需项。 2. The electronic materials that need to be submitted in the Medical Device Recording Application Form , where * is required. Electronic material upload only supports material upload in picture and pdf format. 复印件 1. * Copy of business license and organization code certificate 2. * Copy of the identity certificate, academic qualifications or professional title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality 3. * Description of organization and department setting 4. * Explanation of business scope and business methods 、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议（附房屋产权证明文件）复印件 5. * Geographical map, floor plan, house property certificate or lease agreement (with house property certificate) 6. * Directory of operating facilities and equipment 7. * Catalogue of documents such as operating quality management system and working procedures 8. Basic information introduction and function description of computer information management system 9. * Certificate of authorization of the operator 10. * Scanned copy of the signed and stamped application form 3. The difference between the license and the record is that the license must have the eighth item: the basic information and function description of the computer information management system, and a computer management system.