《第二类医疗器械经营备案》办理指南

随着科技的发展，从事医疗事业人也越来越多，有很多创业者考虑从事医疗器械这一块，其中从事二类医疗器械经营业务就有不少。

二类医疗器械是指，to its security、Medical devices whose effectiveness should be controlled，thermometer、sphygmomanometer；Magnetic therapy equipment；Medical absorbent cotton、Medical skim gauze、医用卫生口罩、医用无菌纱布；家用血糖仪、血糖试纸条、妊娠诊断试纸（早孕检测试纸）、排卵检测试纸；condom、避孕帽；轮椅；电子血压脉搏仪；梅花针、三棱针、acupuncture needle；手提式氧气发生器等都属于第二类医疗器械，凡经营该类医疗器械单位，必须实行备案管理。

必须向有关部门申请备案。第二类医疗器械经营备案办理条件：1.Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；

1. 具有与经营规模和经营范围相适应的经营、办公及储存场所；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；全部委托其他医疗器械经营企业储存的可以不设立库房。

1. A sound product quality management system should be established，包括购进、质量验收、Warehousing and storage、Warehouse review、销售和售后、退换货和召回、不良事件的报告制度等，and strictly enforce；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support；
3. 应收集并保存有关医疗器械监督管理的法律、regulations、Regulations and special provisions。

第二类医疗器械经营备案材料目录：

1. 《第二类医疗器械经营备案表》一份；
2. ?企业《营业执照》正副本复印件各一份；
3. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate：①法定代表人、企业负责人CCC身份证、学历证书复印件各一份；②质量负责人DDD身份证、学历证书复印件各一份；
4. 企业组织机构与部门设置说明一份；
5. Business scope、经营方式说明一份；
6. Business premises、库房地址的地理位置图和注明实际使用面积的平面图各一份；房屋租赁合同和房屋产权证明复印件各一份；
7. 企业经营设施和设备目录一份；
8. 《医疗器械经营质量管理制度》、《工作程序》目录一份。

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