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;
(3)房屋产权证明、租赁协议;
(4)法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料;
作为一个医疗器械资质注册咨询师,我们提供专业的医疗器械二三类资质注册服务,为您提供快捷、便宜的解决方案。如果您的公司需要在朝阳十里河地区注册医疗器械二三类资质,我们将是您的**选择。
医疗器械二三类属于国家食品药品监督管理局规定的医疗器械管理规范中的一种分类,是一种较为常见的医疗器械分类。如果您有相关产品需要上市,就需要完成医疗器械二三类资质注册。
我们的服务快速、便宜且专业。我们非常了解企业在医疗器械资质注册过程中的需求和苦处。我们始终致力于为企业提供优质的服务,以*快速的时间、*优质的服务、*经济的价格为企业解决烦恼。如果您需要注册医疗器械二三类资质,不妨联系我们,为您提供**的咨询服务,快速解决您所有的医疗器械注册问题。
handled as follows: (1) The applicant shall submit theapplication materials to the relevant departments; (2) Relevantdepartments shall accept the application of the applicant; (3)Investigate the actual site and audit the products; (4) Grant theissuance of a class III medical device license. 2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices As for the registration of Class II and IIImedical devices, the following materials shall be submitted: (1)Product risk analysis data; (2) Technical requirements for theproducts; (3) Product inspection report; (4) Clinical evaluationdata; (5) Product specification and label samples; (3) Propertyright certificate and lease agreement; (4) Identity of legalrepresentative, principal person in charge, quality manager,graduation certificate and other certification materials; As amedical device qualification registration consultant, we provideprofessional medical device Class II and Class III qualificationregistration service, to provide you with quick and cheapsolutions. If your company needs to register the qualification inShilihe, Chaoyang, we will be your best choice. Class II and ClassIII of medical devices is one of the categories of medical devicemanagement norms stipulated by the State Food and DrugAdministration, which is a relatively common classification ofmedical devices. If you have related products to be marketed, youneed to complete the registration of class II medical devicequalification. Our service is fast, cheap, and very professional.We are well aware of the needs and hardships of enterprises in themedical device qualification registration process. Therefore, wehave always been committed to providing quality service forenterprises, with the fastest time, the best quality service, themost economical price for the enterprise to solve the troubles. Ifyou need to register the medical device Class II qualification, youmight as well contact us to provide you with first-class consultingservices, and quickly solve all your medical device registrationproblems.