第3类:

是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等。

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;

r 5 years. If the term of validity needs to be extended upon the expiration of the term, the extension procedures shall be handled in accordance with the relevant legal provisions of the administrative license. 1. Materials required for the registration of class III medical equipment knowledge and equipment license 1. Enterprise name and business scope, registered capital and proportion of shareholder contribution, shareholders and other identity certificates; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more certificates, identification certificate and resume of medical professionals or related professionals; 5. Office space and warehouse certificate that meet the