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
随着相关制度的逐步完善,市场环境的逐渐向好,医疗器械或将迎来喷涌爆发式的发展。
s 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, including the organizational structure, quality management system, product sales, etc. License issuance: After the approval, the medical device supervision a