(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;办理三类医疗器械经营许可证的办理流程:
3、具有与经营产品相关的拥有中专以上学历的技术人员;4、拥有与经营的医疗器械相适应的质量管理制度很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如说体外诊断试剂就属于三类医疗器械,只有有相关证书,才能销售这种产品。
2、要办理三类医疗器械经营许可证,必须有相关的营业执照,一般营业执照上的经营范围这一栏,需要明确写道可以销售三类医疗器械。如果没有,需要去工商局办理增项。
3、销售三类医疗器械,你必须要自己的库房,而且库房里需要设置冷藏库,因为三类医疗器械,是有保温
ication for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) product risk analysis materials; (2) technical requirements for the product and (3) product inspection report; Procedures for handling the business license of Class III medical devices: 3. Having technical personnel with technical secondary school education or above related to the business products; 4. Dealers of many drugs or medical devices with a quality management system suitable for the medical devices operated, Without the operating license, A lot of products can't be sold, In vitro diagnostic reagents, for example, fall into three categories of medical devices, Only with the relevant certificates, To sell the product.2. In order to apply for the business license of the third types of medical devices, there must be a relevant business license. In the business scope of the general business license, it is necessary to be clearly stated that the third types of medical devices can be sold. If not, the need to go to the industrial and commercial bureau for additional items.3, the sales of three types of medical equipment, you have to own warehouse, and the warehouse needs to set up cold storage, because the three types of medical equipment, i