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
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品需要办理二类医疗器械经营备案凭证,经营三类产品则需办理医疗理医疗器械三类经营许可证
接下来,北京星期三企业管理可可给大家说说申请医疗器械三类经营许可证的流程及重点有哪些吧。
一、申请医疗器械三类经营许可证的条件:
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;
(二)具有与经营规模和经营范围相适应的相对独立的经营场所;
(三)具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;