公司增加二类医疗器械经营范围
二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、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
requirements of Class II medical devices, according to theRegulations on the Supervision and Administration of MedicalDevices, all units engaged in the business of Class II medicaldevices need to file with the food and drug regulatory departmentof the city divided into districts. Class II medical devices havemoderate risks and need to be controlled and managed to ensuretheir safe and effective medical devices. Such as: medical sutureneedle, sphygmomanometer, thermometer, electrocardiogram machine,electroencephalography machine, microscope, acupuncture needle,biochemical analysis system, hearing aid, ultrasonic disinfectionequipment, non-absorbable sutures, etc. ask: 1. Commercial office60 square, storage 40 square 2.2 medical professionals are theleaders of the enterprise 3. Product management catalogue Note: Ifthe line of the above 3 points, basically can handle the record ofclass II medical devices Provide materials 1. Application forfiling of Class II medical devices 2. Business license or pre-checkname notice 3. Copy of the identity certificate, educationbackground 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
