丰台玉泉营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靠谱周期短Zui快7天下证

4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议(附房屋产权证明文件)复印件5.产品经营目录表

6.产品合格证书

7.上家购销合同、进货渠道

注：二类医疗器械备案有效期为长期，到期前6个月到所在地设区的市级食品药品监督管理部门换发二类医疗器械备案新凭证

三、公司增加三类医疗器械经营范围

三类医疗器械经营许可证要求：

1、场地要求：必须是办公性质，使用面积要zui少达到60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;

n map, floor plan, house property right certificate or leaseagreement (attached with the house property right certificate). 56. product certificate 7. last home purchase andsales contract and purchase channels note: the record validityperiod of class ii medical devices is long-term, and the new recordcertificate of class ii medical devices shall be issued to themunicipal food and drug regulatory department 6 months before theexpiration 3. the company has increased the business scope of thethree types of medical devices re for the businesslicense of class iii medical device: 1, the site re: mustbe the office nature, the use of the area to reach at least 60square meters; 2. personn