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于100平方米，库房使用面积不得少于40平方米。

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. Other relevant laws and regulation requirements. For three types of medical devices, it shall have a business site and warehouse suitable with the scale of operation 1. If the business code is class III-6821 medical electronic equipment, Class III-6846 implant materials artificial organs, Class III-6863 stomatology materials, class III-6877 interventional equipment products, the use area of the business site shall not be less than 100 square meters, and the warehouse area shall not be less