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;
(六)与产品研制、生产有关的质量管理体系文件;
(三)具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产
(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备
(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
e permit shall be handled as follows: (1) The applicant shallsubmit the application materials to the relevant departments; (2)Relevant departments shall accept the application of the applicant;(3) Investigate the actual site and audit the products; (4) Grantthe issuance 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; (6) qualitymanagement system documents related to product development andproduction; (3) It shall have storage conditions suitable for thescale and scope of business, including the production of medicaldevices (6) the enterprise has the drugs that need to berefrigerated (3) Investigate the actual site and audit theproducts; (4) Three categories are grante