朝阳常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全程代办周期短快7天下证

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。

ss scope of the three types of medical devices re forthe business license of class iii medical device: 1, sitere: must be office nature, the use area of at least 60square meters; 2. personnel re: 3 relevant personnel(company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3,product re: must have the product information inaccordance with the business scope, and issue a certificate; 4.other relevant laws and regulation re. for three types ofmedical devices, it shall have a business site and warehousesuitable with the scale of operation 1. if the business code isclass iii-6821 medical electronic e, class iii-6846 implantmaterials artificial organs, class iii-6863 stomatologymaterials,