辦理條件
· 人員要求：
· 企業(yè)應(yīng)具有與經(jīng)營產(chǎn)品相關(guān)的在崗人員，具備相應(yīng)知識和技能。
· 具有與經(jīng)營產(chǎn)品相關(guān)的中專以上學(xué)歷的技術(shù)人員。
· 質(zhì)量管理人員應(yīng)具有國家認(rèn)可的、與經(jīng)營產(chǎn)品相關(guān)的大專以上學(xué)歷或相關(guān)中級以上技術(shù)職稱。經(jīng)營一次性使用無菌醫(yī)療器械的，還應(yīng)有一名以上持有醫(yī)療器械質(zhì)量管理體系內(nèi)審員證書的內(nèi)審員。
· 經(jīng)營場所與倉庫要求3：
· 經(jīng)營場所的面積應(yīng)滿足低要求，通常經(jīng)營場所的使用面積不得小于30平方米；
· 企業(yè)應(yīng)具備與經(jīng)營規(guī)模相適應(yīng)的倉庫，倉庫的面積、設(shè)施、環(huán)境等應(yīng)滿足醫(yī)療器械的儲存要求。對于經(jīng)營一次性使用無菌醫(yī)療器械的企業(yè)，倉庫應(yīng)在同一建筑物內(nèi)，且使用面積不得小于40平方米。
· 質(zhì)量管理體系要求37：
· 企業(yè)應(yīng)建立與經(jīng)營的醫(yī)療器械相適應(yīng)的質(zhì)量管理制度，包括采購、驗收、儲存、銷售、售后服務(wù)等各個環(huán)節(jié)的管理要求。
· 建立醫(yī)療器械質(zhì)量管理檔案或表格，對醫(yī)療器械的質(zhì)量進(jìn)行全程跟蹤和記錄。
· 定期對醫(yī)療器械進(jìn)行質(zhì)量檢查和維護(hù)保養(yǎng)，確保醫(yī)療器械的質(zhì)量和安全。
· 產(chǎn)品要求：必須要有合乎業(yè)務(wù)范圍的產(chǎn)品信息，并出具證書
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