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
business scope of the three types of medical devicesRequirements for the Business License of Class III Medical Device:1, the site requirements: must be the office nature, the use of thearea to reach at least 60 square meters; 2. Personnel requirements:3 relevant personnel (company responsible person, qualityresponsible person, quality inspection personnel) need to recordand hold the certificate; 3, product requirements: must have theproduct information in accordance with the business scope, andissue a certificate; 4. Other relevant laws and regulations andrequirements. For operating three types of medical devices, itshall have a business site and warehouse suitable for the scale ofoperation 1. If the business code is class III-6821 medicalelectronic equipment, Class III-6846 implant materials artificialorgans, Class III-6863 stomatology materials, class III-6877interventional equipment products, the use area of the businesssite shall not be less than 100 square meters, and the warehousearea shall not be less than 40 square meters. 2. Business categorycode is Class III-6815 injection puncture device, Class III-6845extracorporeal circulation and liquid treatment equipment, ClassIII-6864 medical health materials and dressings, and Class III-6865medical equipment
