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;
' 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, the siterequirements: must be the office nature, the use of the area shouldbe less than 45 square meters; 2. Personnel requirements: 3relevant personnel (company responsible person, quality responsibleperson, 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;