)相关部门受理申请人的申请;
(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;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
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。
1、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
Relevant departments shall accept the application of theapplicant; (3) Investigate the actual site and audit the products;(4) Grant the issuance of a class III medical device license. 2.Legal basis: Article 14 of the Regulations on the Supervision andAdministration of Medical Devices As for the registration of ClassII and III medical devices, the following materials shall besubmitted: (1) Product risk analysis data; (2) Technicalrequirements for the products; (3) Product inspection report; (4)Clinical evaluation data; (5) Product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. Many distributors ofdrugs or medical devices can not sell many products without thebusiness license of third class medical devices. For example, invitro diagnostic reagents belong to the third class medicaldevices, and only with relevant certificates can they sell suchproducts. 2. In order to apply for the business license of thethird types of medical devices, there must be a relevant businesslicense. In the business scope of the general business license, itis necessary to be clearly stated that the third types of medicaldevices can be sold. If not, the need to go to the industrial andcommercial bureau for additional items. 3, sales of class threemedical devices, you must