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,应具备与经营规模相适应的经营场所和库房
1.经营类代号为三类-6821医用电子仪器设备、三类-6846植入材料人工器官、三类-6863口腔科材料、三类-6877介入器材产品的,经营场所使用面积不得少于100平方米,库房使用面积不得少于40平方米。
ionals are the leaders of the enterprise 3. Product managementcatalogue Note: If the line of the above 3 points, basically canhandle the record of class II medical devices Provide materials 1.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 representative, the person in charge of the enterpriseand the person in charge of 4. Copy of the geographicallocation map, floor plan, house property right certificate or leaseagreement (attached with the house property right certificate). 56. Product certificate 7. Last home purchase andsales contract and purchase channels Note: The record validityperiod of class 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 has increased the business scope of thethree types of medical devices Re for the BusinessLicense of Class III Medical Device: 1, site re: must bethe office nature, the use of the area to reach at least 60 s; 2. Personnel re: 3 relevant personnel (companyresponsible person, responsible person, inspectionpersonnel) need to record and hold the certificate; 3, pr