、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸收缝合线等。
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
, electroencephalography machine, microscope, acupunctureneedle, biochemical analysis system, hearing aid, ultrasonicdisinfection equipment, non-absorbable sutures, etc. ask: 1.Commercial office 60 square, storage 40 square 2.2 medicalprofessionals are the leaders of the enterprise 3. Productmanagement catalogue Note: If the line of the above 3 points,basically can handle the record of class II medical devices Providematerials 1. Application form for filing of Class II medicaldevices 2. Business license or pre-check name notice 3. Copy of theidentity certificate, education background or professional titlecertificate of the legal representative, the person in charge ofthe enterprise and the person in charge of quality 4. Copy of thegeographical location map, floor plan, house property rightcertificate or lease agreement (attached with the house propertyright certificate). 5 6. Product qualification certificate 7. Lasthome purchase and sales contract and purchase channels Note: Therecord validity period of class II medical devices is long-term,and the new record certificate of Class II medical devices shall beissued to the municipal food and drug regulatory department 6months before the expiration 3. The company has increased thebusiness scope of the three types of medical devices Requirementsfor the Business License of Class III Medical Device: 1, siterequirements: must be office nature, the use area of at least 60square meters; 2, personnel requirements
