医疗器械二三类资质注册，专业咨询，快捷便宜

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，使用面积要最少达到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;

floor plan, house property right certificate or lease agreement (attached with the house property right certificate). 5 6. Product certificate 7. Last home purchase and sales contract and purchase channels Note: The record validity period of class II medical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Re for the Business License of Class III Medical Device: 1, site re: must be office nature, the use area of at least 60 square meters; 2. Personnel re: 3 relevant personnel (company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3, product require