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;
具有与经营的第三类医疗器械相适应的专业指导、技术培训和售后服务的能力,或者相关协议;
1. What is a medical device? Beijing wants tounderstand the enterprises to see here Medical device: refers toinstruments, equipment, appliances, materials or other articlesused individually or in combination, including required software;their function on the surface of the body is not obtained bypharmacological, immunology or metabolic means, but may participateand play a certain auxiliary role. 2. How many categories aremedical devices divided into? There are three categories: Theoperation of the first type of medical devicesdoes