疗器械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;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门的行政决定;
7.制证、发
ment business license 1. The business license of Class IIImedical devices is 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; 2. Data formreview of the Food and Drug Administration; 3. Formal acceptance ofdata; 4. Administrative examination by relevant departments; 5.Site evaluation; 6. Administrative decisions of the relevantdepartments; 7. Certificate making and issuance