医疗器械经营许可证现为后置审批,有效期为5年。有效期届满需要延续的,依照有关行政许可的法律规定办理延续手续。
一、三类医疗器知械许可证注册所需材料
1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学專业或相关專业人员证书、身份证明与简历;
5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员身份证和上岗证;
8、其它相道关材料。
5 years. If the term of validity needs to be extended uponthe expiration of the term, the extension procedures shall behandled in accordance with the relevant legal provisions of theadministrative license. 1. Materials required for the registrationof third III medical equipment license 1. Enterprise name andbusiness scope, registered capital and proportion of shareholdercontribution, shareholders and other identity certificates; 2.Medical device product registration certificate, supplier businesslicense, license and authorization letter; 3. Quality managementdocuments, etc.; 4,2 or more certificates, identificationcertificate and resume of medical professionals or relatedprofessionals; 5. Office space and warehouse certificate that meetthe business requirements of medical equipment; 6. Articles ofassociation, resolutions of shareholders' meeting, etc.; 7. ID cardand post c