医疗器械经营许可证。
医疗企业经营许可证一共有三类，其中办理一类医疗器械许可证可以直接办理，经营二类产品是需要办理二类医疗器械经营备案凭证，经营三类产品则需要办理三类医疗器械经营许可证。经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。（一）具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关学历或者职称，质量管理人应在职在岗，不得在其他单位兼职；（二）具有与经营规模和经营范围相适应的相对独立的经营场所；（三）具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；（四）应当建立健全产品质量管理制度，包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等；（五）应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。（六）具有与经营的医疗器械相适应的质量管理制度。
经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(1)提交医疗器械经营企业许可证申请表，法定代表人签字或加盖企业公章；
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件；
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历；质量管理人员的身份证、学历或者职称证明复印件；
(4)经营场所、仓库的地理位置图、平面图（注明面积）、房屋产权证明或者租赁协议复印件；
(5)企业产品质量管理制度文件及储存设施、设备目录。
(6）对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时，企业具备的运输装备、仓储设施设备情况表。
Business license of medical devices.
There are three types of business licenses for medicalenterprises, among which the first type of medical device licensecan be directly processed, the second type of product requires asecond type of medical device business registration certificate,and the third type of product requires a third type of medicaldevice business license. Firstly, the operating enterprise mustclarify the conditions for applying for a Class III medical deviceoperating license and meet the relevant requirements. （1） Havingtwo quality management organizations or personnel that are suitablefor the scale and scope of operations. Quality management personnelshall have relevant professional education or professional titlesrecognized by the state. Quality management personnel shall be onduty and shall not hold part-time positions in other units; （2）Having a relatively independent business premises that are suitablefor the scale and scope of operations; （3） Having storageconditions that are suitable for the scale and scope of operation,including storage facilities and equipment that meet therequirements of medical device product characteristics; （4） A soundproduct quality management system should be established, includingprocurement, incoming inspection, warehousing and storage, outboundreview, quality tracking system, and reporting system for adverseevents; （5） It should have the ability to provide technicaltraining and after-sales service that is suitable for the medicaldevice products it operates. （6） Having a quality management systemthat is compatible with the medical devices being operated.
Secondly, operating enterprises need to know what documents arerequired to apply for the three types of medical device operatinglicenses.
(1) Submit the application form for the license of medicaldevice operating enterprises, with the legal representative signingor affixing the company seal;
(2) Copy and original verification of the enterprise namepre-approval certificate or Business License issued by theAdministration for Industry and Commerce;
(3) Copy of the ID card, educational background or professionaltitle certificate, and personal resume of the person in charge ofenterprise quality management; Copy of ID card, educationalbackground or professional title certificate of quality managementpersonnel;
(4) Geographical location map, floor plan (indicating area),property ownership certificate or copy of lease agreement of thebusiness premises and warehouse;
(5) Enterprise product quality management system documents,storage facilities, and equipment catalogs.
(6) When applying for a Class III medical device businesslicense that includes drugs that require refrigeration, thetransportation equipment and storage facilities and equipment thatthe enterprise has are listed in the table.