First of all, we must be clear about what information is needed for the three types of business license of medical devices; 1. Company license principal and secondary copy 2. Official seal 3. Copy of the office and warehouse room 4. Personnel (mainly the quality manager and the competent inspector) Among them, quality manager: required college graduation for three years Supervisor inspector: required to graduate for three years of laboratory related major
一、《医疗器械经营许可证》怎么办理?
医疗器械企业办理的程序主要包括以下3个步骤:
1.申请营业执照
执照经营范围带第一类医疗器械销售:第二类医疗器械销售;第三类医疗器械经营。
2.准备资质许可证申请材料
医疗器械经营许可申请表;法定代表人、企业负责人、质量负责人的中华人民共和国居民身份证、学历或者职称证书;企业基本情况;企业设施设备情况;企业对所提供材料真实性的声明
3.申请资质许可证
提交第二类医疗器械经营备案凭证申请和医疗器械经营许可证申请