三類醫(yī)療: | 許可證注冊 |
二類醫(yī)療器械: | 二類備案 |
二類三類許可證: | 注冊+轉(zhuǎn)讓 |
單價(jià): | 2500.00元/件 |
發(fā)貨期限: | 自買家付款之日起 天內(nèi)發(fā)貨 |
所在地: | 直轄市 北京 北京昌平 |
有效期至: | 長期有效 |
發(fā)布時(shí)間: | 2023-12-14 18:35 |
最后更新: | 2023-12-14 18:35 |
瀏覽次數(shù): | 100 |
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三類醫(yī)療器械經(jīng)營許可證如何辦理
1、三類醫(yī)療器械經(jīng)營許可證辦理方式如下:
(1)申請人提交申請資料到相關(guān)部門;
(2)相關(guān)部門受理申請人的申請;
(3)到實(shí)際場地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核;
(4)準(zhǔn)予頒發(fā)三類醫(yī)療器械許可證。
三類醫(yī)療器械作為目前醫(yī)療器械分類中危險(xiǎn)性最高的品類,嚴(yán)格受到相關(guān)部門的監(jiān)督和管理,但是對于很多經(jīng)營三類醫(yī)療器械的家人們來說,很多基礎(chǔ)性問題還不能完全掌握,今天我們就來看一看,三類醫(yī)療器械經(jīng)營范圍有哪些?又該如何申請三類醫(yī)療器械經(jīng)營許可證!
handle the business license of class III medical devices
1. The business license of Class III medical devices is handled as follows:
(1) The applicant shall submit the application materials to the relevant departments;
(2) Relevant departments shall accept the application of the applicant;
(3) Investigate the actual site and audit the products;
(4) Grant the issuance of a class III medical device license.
Three kinds of medical devices as the highest risk in the medical device classification category, strictly by the supervision and management, but for many families of three kinds of medical devices, many basic problems is not fully grasp, today we will take a look, what are three business scope of medical devices? How to apply for the three types of medical e business license again!
醫(yī)療器材經(jīng)營許可證申請流程:
(一)申請
申請人持申報(bào)資料向省,自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門提出申請,
(二)受理
電指資料技限食品藥元公務(wù)管理局政務(wù)大廳,經(jīng)審查,申話二項(xiàng)有法量千本部門責(zé)范電,申報(bào)資制符合機(jī)定些慶的,予以零理,并十展《四理請知書》
對申報(bào)資料存在可以當(dāng)場更正的錯(cuò)誤的,允許申請人當(dāng)場更正,對申報(bào)資料不齊全或不符合要求的,在5個(gè)工作日內(nèi)發(fā)給申請人《補(bǔ)正資料通知書》,一次性告知
申請人品要撲正的全部內(nèi)容:申請事項(xiàng)優(yōu)法不屬于本部門職專范圍的,出具《不予要理通知書》