聘请专业人员:聘请具有相关医疗器械经营经验的专业人员,如负责人、注册人员、经营管理人员、技术人员等。
提交申请材料:提交申请材料包括医疗器械经营许可证申请表、医疗器械经营许可证颁发范围的说明、公司营业执照、组织机构代码证、税务登记证、法人代表身份证、医疗器械经营负责人和技术人员的聘书、企业的药品经营质量管理规范制度及其实施情况、医疗器械的采购渠道、销售情况等。
现场审核:申请材料提交后,医疗器械监督管理部门将对企业进行现场审核,包括场地、人员、质量管理、医疗器械采购、销售等方面的审核。
预审:现场审核合格后,医疗器械监督管理部门将对申请材料进行预审。
审核:预审合格后,医疗器械监督管理部门将进行审核,审核包括企业的组织架构、质量管理体系、产品销售情况等方面。
颁发许可证:审核通过后,医疗器械监督管理部门将颁发医疗器械经营许可证。
申请三类医疗器械经营许可证需要满足相关的资质要求和管理要求,申请过程比较复杂,建议企业在申请前了解相关政策法规,以及咨询专业的医疗器械代办公司或律师事务所,提高申请成功率
gal representative id card, medical equipment management and appointment of technical personnel, the enterprise drug management quality management system and its implementation, medical equipment procurement channels, sales, etc. On-site audit: After the application materials are submitted, the medical device supervision and administration department will conduct on-site audit of the enterprise, including site, personnel, quality management, medical device procurement and sales. Pre-examination: After passing the on-site examination, the medical device supervision and administration department will conduct pre-examination of the application materials. Audit: After the pre-examination, the medical device supervision and management department will conduct an audit, inclu