北京丰台北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

药品监督管理局逐步推行医疗器械管理质量标准化管理体系。医疗器械经营质量管理规范由国家美国食品药品监督管理局制定。

许可证的办理条件

根据《医疗器械监督管理条例》第三十一条的规定，从事第三类医疗器械业务的，经营企业应当向所在地设区的市级人民政府食品药品监督管理部门申请经营许可。

1.有与经营范围相适应的营业场所和仓库，并有特定的面积要求；

2.具有国家认可的专门从事产品经营的在职人员；

3、应有具有中专以上学历的与产品管理相关的技术人员；

4.具有与所经营的医疗器械相适应的质量管理体系。

许可证的所需材料

1.营业执照；

2.企业负责人、质量检验人员和技术人员的身份、学历和职称证明；

3.营业场所证明和地理位置图。

y implemented the standardized management system of medical device management and quality. The quality management standards for medical devices are formulated by the United States Food and Drug Administration. Conditions for handling the permit According to Article 31 of the Regulations on the Supervision and Administration of Medical Devices, those engaged in the third class of medical device business shall apply for a business license to the food and drug supervisory and administrative department of the people's government of the city divided into districts where it is located. 1. Have business sites and warehouses suitable for the business scope, and have specific area requirements; 2. On-the-job personnel recognized by the state and specialized in product management; 3. There should be