通州东关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

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

an 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 4. copy of thegeographical location map, floor plan, house property rightcertificate or lease agreement (attached with the house propertyright certificate). 5 6. product 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 re the business license of class iii medical device: 1, the sitere: must be the office nature, the use of the