东城建国北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证

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。

新政策要求：医疗器械经营企业要在经营活动中积极应用唯一标识，做好带码入库、出库，实现产品在流通环节可追溯。

医疗器械经营许可证申请须知

医疗器械经营许可证是医疗器械经营企业必须具备的，开办第二类医疗器械经营企业，应当向省、自治区、直辖市人民政府药品监督管理部门备案；

开办第三类医疗器械经营企业，应当经省、自治区、直辖市人民政府药品监督管理部门审查批准，并发给《医疗器械经营许可证》。

依据《医疗器械经营监督管理办法》，开设三类医疗器械运营公司，食品类药品监督管理局单位将会对经营地开展当场审查。对不符合要求标准的，明确提出整顿规定或未予批准。根据《药品医疗器械飞行检查办法》，食品类药品监督管理局单位将会对医疗机械销货方式合理合法、工作人员在职人员在职、拿货检查、运送储存等层面开展不事先告之的监督管理。三类医疗器械的界定

依据《医疗器械监督管理条例》，第三类医疗器械是具备较高危，必须采用非常对策严控管理方法以确保其安全性、合理的医疗机械。例如普遍的注射器、注射针、静脉留置针、心脏支架、麻醉机、CT、磁共振等。

device supervision and administration department will conductpre-examination of the application materials. Audit: After thepre-examination, the medical device supervision and managementdepartment will conduct the audit, including the organizationalstructure, quality management system, product sales, etc. Licenseissuance: After the approval, the medical device supervision andadministration department will issue the medical device businesslicense. The application for the business license of Class IIImedical devices should meet the relevant qualification requirementsand management requirements, and the application process is quitecomplicated. It is suggested that enterprises understand therelevant policies and regulations before the application, as wellas consult professional medical device agency companies or lawfirms, so as to improve the success rate of the application Withthe gradual improvement of relevant systems and the gradualimprovement of the market environment, medical devices may usher inthe explosive development. The new policy requirements: medicaldevice operating enterprises should actively apply the uniqueidentification in their business activities, do a good job ofwarehousing and warehousing with codes, and realize thetraceability of products in the circulation link. Instructions forapplication of medical Device Business License The medical devicebusiness license is necessary for the medical device tradingenterprise, and the establishment of the second class medicaldevice trading enterprise shall be filed by the drug regulatorydepartment of the people's government of the provincial, autonomousregion or municipality