First of all, we must be clear about whatinformation is needed for the three types of business license ofmedical 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) Amongthem, quality manager: required college graduation for three yearsSupervisor inspector: required to graduate for three years oflaboratory related major
如果要从事第三类医疗器械产品经营,那么就必须先取得《医疗器械经营许可证》才能经营第三类医疗器械产品。办理三类经营许可证也是企业经营第三类产品必不可少的一项资质。
在北京办理三类医疗器械经营许可证有什么要求?企业要满足哪些条件?
办理流程是什么?
有与经营的第三类医疗器械相适应的营业场所和仓储场所,并提供经营场地的产权证明或者租赁合同;
有与经营的第三类医疗器械相适应的质量管理制度;