要求：
1.商用性质办公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
e: If the line of the above 3 points, basically can handle therecord of class II medical devices Provide materials 1. Applicationform for filing of Class II medical devices 2. Business license orpre-check name notice 3. Copy of the identity certificate,education background or professional title certificate of the legalrepresentative, the person in charge of the enterprise and theperson in charge of quality 4. Copy of the geographical locationmap, floor plan, house property right certificate or leaseagreement (attached with the house property right certificate). 56. Product qualification certificate 7. Last home purchase andsales contract and purchase channels Note: The validity period ofclass II medical devices is long-term, and the new recordcertificate 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, site requirements: must bethe office nature, the use of the area to reach at least 60 squaremeters; 2. Personnel requirements: 3 relevant personnel (companyresponsible person, quality responsible person, quality inspectionpersonnel) need to record and hold the certificate; 3, productrequirements: must have the product information in accordance withthe business scope, and issue a certificate; 4. Other relevant lawsand regulations and requirements. For operating three types ofmedical devices, it shall have a business site and w
