通州马驹桥北京医疗器械三类经营许可证二三类专业快捷包拿证

经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下：
（1）申请人提交申请资料到相关部门；
（2）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；
7.制证、发证。
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，库房里需要设置冷藏库，因为三类医疗器械，是有保温需要的，超过一定的温度，就容易变

handle the business license 1 is as follows: (1) the applicantsubmits the application materials to the relevant departments; (2)the relevant departments accept the application of the applicant;(3) investigate the actual site and review the products; (4) grantthe issuance of the Class III medical device license.2. Legalbasis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices and application for registrationof Class II and Class III medical devices, the following materialsshall be submitted: (1) product risk analysis data; (2) producttechnical requirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; 7.Certificate preparation and certification. 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 the thirdtypes 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, the sales of three typesof medical equipment, you must have their own warehouse, and thewarehouse needs to set up cold warehouse, because three types ofmedical equipment, is insulation needs, beyond a certaintemperature, it is easy to change