國(guó)家對(duì)經(jīng)營(yíng)和銷售醫(yī)療器械的企業(yè)按照風(fēng)險(xiǎn)程度分為三類進(jìn)行管理，這也就導(dǎo)致很多人認(rèn)為醫(yī)療器械經(jīng)營(yíng)許可證也分為三類.
在北京如何辦理三類醫(yī)療經(jīng)營(yíng)許可證，辦理許可證又有哪些條件及流程污涤，小編帶著滿滿的干貨知識(shí)與您分享饶饿。
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(shè)備狰娱、器具侮捷、體外診斷試劑及校準(zhǔn)物、材料以及其他類似或者相關(guān)的物品续疲，包括所需要的計(jì)算機(jī)軟件偶画。而醫(yī)療器械經(jīng)營(yíng)許可證是三類醫(yī)療器械經(jīng)營(yíng)企業(yè)必須具備的證件。
國(guó)家對(duì)醫(yī)療器械按照風(fēng)險(xiǎn)程度實(shí)行分類管理嘁梦。
經(jīng)營(yíng)一類醫(yī)療器械不需許可和備案祟期，執(zhí)照上面加上銷售醫(yī)療器械一類就可以正常銷售；
經(jīng)營(yíng)二類醫(yī)療器械需要辦理備案滩蔼；
經(jīng)營(yíng)三類醫(yī)療器械需要辦理經(jīng)營(yíng)許可證希弟。
辦理二類備案您需要提供：
1.法人身份信息；
2.質(zhì)量員身份信息粥搓；
3.公司營(yíng)業(yè)執(zhí)照正副本以及公章洞枷；
4.庫(kù)房地址材料；
窗口交件后當(dāng)天拿二類備案鳖昌。
三類醫(yī)療器知械許可證注冊(cè)所需材料
1备畦、醫(yī)療器械產(chǎn)品注冊(cè)證書(shū)、供應(yīng)商營(yíng)業(yè)執(zhí)照许昨、許可證及授權(quán)書(shū);
2懂盐、質(zhì)量管理文件等;
3、2個(gè)或以上醫(yī)學(xué)專業(yè)或相關(guān)專業(yè)人員證書(shū)糕档、身份證明與簡(jiǎn)歷;
4莉恼、符合醫(yī)療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉(cāng)庫(kù)證明;
5、其它相道關(guān)材料速那。
窗口交件后5個(gè)工作日核查俐银，核查通過(guò)后下證。
關(guān)于在京辦理三類醫(yī)療器械經(jīng)營(yíng)許可證的更多問(wèn)題端仰，歡迎私信小編捶惜，
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,