办理条件
· 人员要求：
· 企业应具有与经营产品相关的在岗人员，具备相应知识和技能。
· 具有与经营产品相关的中专以上学历的技术人员。
· 质量管理人员应具有国家认可的、与经营产品相关的大专以上学历或相关中级以上技术职称。经营一次性使用无菌医疗器械的，还应有一名以上持有医疗器械质量管理体系内审员证书的内审员。
· 经营场所与仓库要求3：
· 经营场所的面积应满足低要求，通常经营场所的使用面积不得小于30平方米；
· 企业应具备与经营规模相适应的仓库，仓库的面积、设施、环境等应满足医疗器械的储存要求。对于经营一次性使用无菌医疗器械的企业，仓库应在同一建筑物内，且使用面积不得小于40平方米。
· 质量管理体系要求37：
· 企业应建立与经营的医疗器械相适应的质量管理制度，包括采购、验收、储存、销售、售后服务等各个环节的管理要求。
· 建立医疗器械质量管理档案或表格，对医疗器械的质量进行全程跟踪和记录。
· 定期对医疗器械进行质量检查和维护保养，确保医疗器械的质量和安全。
· 产品要求：必须要有合乎业务范围的产品信息，并出具证书
Processing conditions
·Personnel requirements:
·Enterprises should have on-the-job personnel with relevantprofessional knowledge and skills related to operatingproducts.
·Technical personnel with a vocational school diploma or aboverelated to the operation of products.
·Quality management personnel should have a nationallyrecognized college degree or above or an intermediate technicaltitle in a relevant field related to the operation of products. Forthe operation of disposable sterile medical devices, there shouldalso be one or more internal auditors holding a certificate ofmedical device quality management system internal auditor.
·Business premises and warehouse requirements 3:
·The area of the business premises should meet the minimumrequirements, and usually the usable area of the business premisesshould not be less than 30 square meters;
·Enterprises should have warehouses that are suitable for theirbusiness scale, and the warehouse area, facilities, environment,etc. should meet the storage requirements for medical devices. Forenterprises operating disposable sterile medical devices, thewarehouse should be located in the same building and the usablearea should not be less than 40 square meters.
·Quality Management System Requirement 37:
·Enterprises should establish a quality management system thatis suitable for the operation of medical devices, includingmanagement requirements for procurement, acceptance, storage,sales, after-sales service, and other aspects.
·Establish medical device quality management files or forms totrack and record the quality of medical devices throughout theprocess.
·Regularly conduct quality inspections and maintenance ofmedical devices to ensure their quality and safety.
·Product requirements: There must be product information thatmeets the business scope and a certificate must be issued