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。

2.经营类代号为三类-6815注射穿刺器械、三类-6845体外循环及液处理设备、三类-6864医用卫生材料及敷料、三类-6865医用缝合材料及粘合剂、三类-6866医用高分子材料及制品的,经营场所使用面积不得少于60平方米，库房使用面积不得少于80平方米。

3.从事类代号为三类-6822医用光学器具、仪器及内窥镜设备(jinxian软性角膜接触镜)类零售业务的，应设有独立的柜台;其中提供验配服务的，经营场所使用面积不得少于30平方米，验光室(区)应具备暗室条件或满足无直射照明的条件。

4.经营除上述类代号以外其他三类类医疗器械的，经营场所使用面积不得少于

usiness License of Class III Medical Device: 1, the site requirements: must be the office nature, the use of the area to reach 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. Other relevant laws and regulations and 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 than 40 square meters. 2. Business class code for three-6815 injection puncture instruments, three-6845 extracorporeal circulation and liquid treatment equipment, three-6864 medical health materials and dressings, three-6865 medical suture materials and adhesives, three-6866 medical polymer materials and products, premises use area of not less than 60 square meters, warehouse use area shall not be less than 80 square meters. 3. Engaged in the retail business of Class III-6822 medical optical instruments and endoscopic equipment (soft contact lenses