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;

4、其他相关法律法规要求。

经营三类类医疗器械的，应具备与经营规模相适应的经营场所和库房

1.经营类代号为三类-6821医用电子仪器设备、三类-6846植入材料人工器官、三类-6863口腔科材料、三类-6877介入器材产品的，经营场所使用面积不得少

rchase channels Note: The validity period of class II medical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Requirements for the Business License of Class III Medical Device: 1, site requirements: must be office nature, the use area of at least 60 square meters; 2. Personnel requirements: 3 relevant personnel (company responsible person, quality responsible person, quality inspection personnel) need to record and hold the certificate; 3, product requirements: must have the product information in accordance with the business scope, and issue a certificate; 4.