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。
二、办理三回类医疗器械许可证的要求：
1、场地要求：必须是办公性质，使用面积要少达到45平方米;
2、人员要求：需要有3名相关人员(公司负责人、质量负责人、质量检查人员)的备案并且持有证书;
3、产品要求：必须要有合乎业务范围的产品信息，并出具证书;
4、其他相关法律法规要求。
三、办理三类医疗器械许可证的流程：
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。
n letter; 3. Quality management documents, etc.; 4,2 or morecertificates, identification certificate and resume of medicalprofessionals or related professionals; 5. Office space andwarehouse certificate that meet the business requirements ofmedical equipment; 6. Articles of association, resolutions ofshareholders' meeting, etc.; 7. ID card and post card of financialpersonnel; 8, other phase channel clearance materials. 2.Requirements for three-of medical device license: 1, siterequirements: must be office nature, the use area should be lessthan 45 square meters; 2. Personnel requirements: 3 relevantpersonnel (company responsible person, quality responsible person,quality inspection personnel) need to record and hold thecertificate; 3, product requirements: must have the productinformation in accordance with the business scope, and issue acertificate; 4. Other relevant laws and regulations andrequirements. 3. Procedures for obtaining the Class III MedicalDevice License: 1. The applicant shall submit the
