海淀公主坟北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富安全时效快可靠快捷

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;

ates, identification certificate and resume of medical professionals or related professionals; 5. Office space and warehouse certificate that meet the business requirements of medical equipment; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7. ID card and post card of financial personnel; 8, other phase channel clearance materials. 2. Requirements for three-of medical device license: 1, the site requirements: must be the office nature, the use of the area should be less than 45 square meters; 2. Personnel requirements: 3 relevant personnel (company responsible person, quality responsible person, quality inspection personnel) need to record and hold