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。
申请办理三类医疗器械许可证必须提前准备的原材料
（1）企业营业执照；
（2）公司章；
（3）房屋产权证明、租赁协议；
（4）法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料；
（5）经营地平面设计图，仓库平面设计图。
申请办理三类医疗器械许可证的规定
（1）场所和仓库总面积规定：与经营地企业规模相一致。
（2）品质管理员规定：专科本科以上学历或是初级左右专业职称，另外理应具备3年左右医疗器械经营品质管理方面亲身经历。
（3）品质管理员技术专业规定：医疗机械有关技术专业，例如：医药学、药理学、生物技术、护理专业等。
三类医疗器械许可证怎么样办
realize the traceability of products in the circulation link. Instructions for application of medical Device Business License The medical device business license is necessary for the medical device trading enterprise, and the establishment of the second class medical device trading enterprise shall be filed by the drug regulatory department of the people's government of the provincial, autonomous region or municipality directly under the Central Government; The establishment of a class III medical device trading enterprise shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, and a Medical Device Trading License shall be issued. According to the Measures for Supervision and Administration of Medical Device Operation, the third type of medical device operating company will be established, and the food and Drug Administration will carry out on-the-spot examination of the place of operation. For those that do not meet the requirements, the rectification provisions shall be clearly prescribed or shall not be approved. According to the Measures for Flight Inspection of Drugs and Medical Devices, the Food and Drug Administration will carry out supervision and management of the reasonable and legal sales methods of medical machinery, the staff, the inspection, transportation and storage. Definition of Class III medical devices
