國家對經營和銷售醫(yī)療器械的企業(yè)按照風險程度分為三類進行管理，這也就導致很多人認為醫(yī)療器械經營許可證也分為三類.
在北京如何辦理三類醫(yī)療經營許可證，辦理許可證又有哪些條件及流程，小編帶著滿滿的干貨知識與您分享。
什么叫做醫(yī)療器械?醫(yī)療器械是指直接或者間接用于人體的儀器、設備、器具、體外診斷試劑及校準物、材料以及其他類似或者相關的物品，包括所需要的計算機軟件。而醫(yī)療器械經營許可證是三類醫(yī)療器械經營企業(yè)必須具備的證件。
國家對醫(yī)療器械按照風險程度實行分類管理。
經營一類醫(yī)療器械不需許可和備案，執(zhí)照上面加上銷售醫(yī)療器械一類就可以正常銷售；
經營二類醫(yī)療器械需要辦理備案；
經營三類醫(yī)療器械需要辦理經營許可證。
辦理二類備案您需要提供：
1.法人身份信息；
2.質量員身份信息；
3.公司營業(yè)執(zhí)照正副本以及公章；
4.庫房地址材料；
窗口交件后當天拿二類備案。
三類醫(yī)療器知械許可證注冊所需材料
1、醫(yī)療器械產品注冊證書、供應商營業(yè)執(zhí)照、許可證及授權書;
2、質量管理文件等;
3、2個或以上醫(yī)學專業(yè)或相關專業(yè)人員證書、身份證明與簡歷;
4、符合醫(yī)療器械經營要求的辦公場地及倉庫證明;
5、其它相道關材料。
窗口交件后5個工作日核查，核查通過后下證。
關于在京辦理三類醫(yī)療器械經營許可證的更多問題，歡迎私信小編，
The state classifies enterprises engaged in the operation and saleof medical devices into three categories for management based onthe degree of risk, which has led many people to believe thatmedical device operating licenses are also classified into threecategories
How to apply for three types of medical business licenses inBeijing, and what are the conditions and procedures for obtaininglicenses? With a wealth of practical knowledge, I will share withyou.
Firstly, what is a medical device? Medical devices refer toinstruments, equipment, tools, in vitro diagnostic reagents andcalibrators, materials, and other similar or related items directlyor indirectly used for the human body, including the requiredcomputer software. The medical device operating license is anecessary document for three types of medical device operatingenterprises.
The state implements classified management of medical devicesaccording to their level of risk.
Operating a type of medical device does not require a license orfiling, and adding the category of selling medical devices to thelicense allows for normal sales;
Registration is required for the operation of Class II medicaldevices;
Operating three types of medical devices requires obtaining abusiness license.
To apply for Class II filing, you need to provide:
1. Corporate identity information;
2. Identity information of the quality officer;
3. Original and duplicate copies of the company's business licenseand official seal;
4. Warehouse address materials;
After submitting the documents at the window, register them asClass II on the same day.
Materials required for registration of Class III medical devicelicense
1. Medical device product registration certificate, supplierbusiness license, permit, and authorization letter;
2. Quality management documents, etc;
3. Two or more medical or related professional certificates,identification documents, and resumes;
4. Proof of office space and warehouse that meet the requirementsfor medical device operation;
5. Other related materials.
After submitting the documents at the window, it will be verifiedwithin 5 working days. Once the verification is passed, thecertificate will be issued.
For more questions about obtaining the business license for threetypes of medical devices in Beijing, please feel free to send aprivate message to the editor,