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。
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。
the Business License of Class III Medical Device: 1, siterequirements: must be the office nature, the use of the area toreach at least 60 square meters; 2. Personnel requirements: 3relevant personnel (company responsible person, quality responsibleperson, quality inspection personnel) need to record and hold thecertificate; 3, product requirements: must have the productinformation in accordance with the business scope, and issue acertificate; 4. Other relevant laws and regulations andrequirements. For three types of medical devices, it shall have abusiness site and warehouse suitable with the scale of operation 1.If the business code is class III-6821 medical electronicequipment, Class III-6846 implant materials artificial organs,Class III-6863 stomatology materials, class III-6877 interventionalequipment products, the use area of the business site shall not beless than 100 square meters, and the warehouse area shall not beless than 40 square meters. 2. Busines
