海淀五彩城北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件库房速度快专业方便，

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于100平方米，库房使用面积不得少于40平方米。

ord certificate 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 Requirements for the BusinessLicense of Class III Medical Device: 1, the site requirements: mustbe the office nature, the use of the area to reach at least 60square meters; 2. Personnel requirements: 3 relevant personnel(company responsible person, quality responsible person, qualityinspection personnel) need to record and hold the certificate; 3,product requirements: must have the product information inaccordance with the business scope, and issue a certificate; 4.Other relevant laws and regulations and requirements. For operatingthree types of medical devices, it shall have a business site andwareh