质办公60平，仓储40平
2.2名医学专业人员为企业负责人
3.产品经营目录
注：符合以上3点，基本上就可以办理二类医疗器械备案
提供材料
1.二类医疗器械备案申请书
2.营业执照或预先核名通知书
3.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件
4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议(附房屋产权证明文件)复印件5.产品经营目录表
6.产品合格证书
7.上家购销合同、进货渠道
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
prise 3. Product management catalogue Note: If the line of theabove 3 points, basically can handle the record of class II medicaldevices Provide materials 1. Application form for filing of ClassII medical devices 2. Business license or pre-check name notice 3.Copy of the identity certificate, education background orprofessional title certificate of the legal representative, theperson in charge of the enterprise and the person in charge ofquality 4. Copy of the geographical location map, floor plan, houseproperty right certificate or lease agreement (attached with thehouse property right certificate). 5 6. Product qualificationcertificate 7. Last home purchase and sales contract and purchasechannels Note: The validity period of class II medical devices islong-term, and the new record certificate of Class II medicaldevices shall be issued to the municipal food and drug regulatorydepartment 6 months before the expiration 3. The company hasincreased the business scope of the three types of medical devicesRequirements for the Business License of Class III Medical Device:1, 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. Business code for class III-6821 medical electronicinstruments and equipment, Class III-6846 implant materials andartificial organs, Class III-6863 stomatology materials, and C
