西城西便门北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证

一、公司增加一类医疗器械经营范围

第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。

一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。

二、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

the first type of medical devices refer to the medical devicesthat are sufficient to ensure their safety and effectivenessthrough routine management. class i medical license does not needfor a business license. if it is making medical devices, it needsto file with the relevant departments. 2. the company has increasedthe business scope of class ii medical devices according to thefiling re 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 disinfectione, non-absorbable sutures, etc. ask: 1. commercial natureof the office 60 square, storage 40 square 2.2 medicalprofessionals are the leaders of the enterprise 3. productmanagement catalogue note: to meet the above 3 points, basicallycan handle the record of class ii medical devices provide materials1. application for filing of class ii medical devices 2. businesslicense or pre-check name notice 3. copy of the identitycertificate, education background or professional title certificateof the legal r