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。
办理后的注意事项
1.医疗器械经营许可证的有效期只有5年。有效期需要延长的,医疗器械经营企业应当在有效期届满前6个月向原发证部门申请延期《医疗器械经营许可证》;
2.具有符合医疗器械经营质量管理要求的计算机信息管理系统,确保产品的可追溯性;
secondary school education or above; 4. Have a qualitymanagement system suitable for the medical devices it operates.Materials required for the permit 1. Business license; 2. Theidentity, educational background and professional title certificateof the person in charge of the enterprise, the quality inspectionpersonnel and the technical personnel; 3. Business site certificateand geographical location map. Matters needing attention afterhandling 1. The validity period of the medical device businesslicense is only 5 years. If the period of validity needs to beextended, the medical device trading enterprise shall apply to theoriginal license issuing department for the extension of theMedical Device Business License 6 months before the expiration ofthe validity period; 2. Have a computer information managementsystem that meets