(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;
(四)临床评价资料;
(五)产品说明书以及标签样稿;申请人隐瞒有关情况或者提供虚假材料的,省、
办理三类医疗器械经营许可证的条件如下:
为三类医疗器械,是有保温需要的,超过一定的温度,就容易变质影响产品质量,所以很少有经销商有销售三类医疗器械的资格。
4、去工商局办理增项,是需要带着工商局的工作人员来查看库房的,你zuihao把库房收拾一下,然后领取《医疗器械经营企业许可申请表》并填写,并把企业相关资质全部带上,还需要带上质量人员的相关资料。
5、三类医疗器械经营许可证,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要办理二类医疗器械经营备案凭证,经营三类产品则需要办理三类医疗器械经营许可证。
首先,经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。
There is a need for thermal insulation, Above a certain temperature, It is easy to deteriorate and affect the quality of products, So very few dealers are qualified to sell three types of medical devices.4, go to the Industrial and commercial Bureau for additional items, is the need to take the staff of the Industrial and commercial Bureau to check the warehouse, you had better clean up the warehouse, and then get the "medical device business enterprise license application form" and fill in, and bring all the relevant qualifications of the enterprise, but also need to bring the relevant information of quality personnel.5. The business license of Class III medical devices needs to be handled directly by the food and drug supervision and administration department of the municipal people's government, and shall be reviewed within 30 days after receiving the materials. If the relevant regulations are met, the business license of Class III medical devices can be issued. There are three types of medical enterprise business licenses, among which the first class medical device license can be directly handled, the operation of second class products needs to apply for the recor