醫(yī)療器械三類: | 注冊 |
醫(yī)療器械二類: | 注冊 |
注冊公司: | 網(wǎng)絡銷售備案 |
單價: | 面議 |
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 北京海淀 |
有效期至: | 長期有效 |
發(fā)布時間: | 2023-11-25 06:49 |
最后更新: | 2023-11-25 06:49 |
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申請辦理三類醫(yī)療器械許可證必須提前準備的原材料
(1)企業(yè)營業(yè)執(zhí)照;
(2)公司章;
(3)房屋產(chǎn)權(quán)證明、租賃協(xié)議;
(4)法定代表人、主要負責人、品質(zhì)管理員的身份、畢業(yè)證等證明材料;
(5)經(jīng)營地平面設計圖,倉庫平面設計圖。
申請辦理三類醫(yī)療器械許可證的規(guī)定
(1)場所和倉庫總面積規(guī)定:與經(jīng)營地企業(yè)規(guī)模相一致。
(2)品質(zhì)管理員規(guī)定:??票究埔陨蠈W歷或是初級左右專業(yè)職稱,另外理應具備3年左右醫(yī)療器械經(jīng)營品質(zhì)管理方面親身經(jīng)歷。
(3)品質(zhì)管理員技術(shù)專業(yè)規(guī)定:醫(yī)療機械有關(guān)技術(shù)專業(yè),例如:醫(yī)藥學、藥理學、生物技術(shù)、護理專業(yè)等。
三類醫(yī)療器械許可證怎么樣辦
充分考慮醫(yī)藥行業(yè)相關(guān)法律法規(guī)及管控規(guī)定許多 ,跨專業(yè)工作人員沒辦法申請辦理取得成功或產(chǎn)生后遺癥,
提議找醫(yī)療器械專業(yè)第三方服務項目組織申請辦理。由于第三方資源廣,基礎的法律法規(guī)都一清二楚,提前準備材料自然游刃有余。
ns: consistent with the scale of the enterprise in the operating place. (2) administrator regulations: college degree or above or junior professional title, in addition, should have about 3 years of personal experience in medical device business management. (3) Technical professional regulations of administrators: related technical majors of medical machinery, such as medicine, pharmacology, biotechnology, nursing majors, etc. How to do the third-class medical device license Fully considering the relevant laws and regulations and control provisions of the pharmaceutical industry, cross-professional staff cannot apply for success or sequelae, I propose to apply for a professional third-party service project of medical devices. Due to the wide range of third-party resources, the basic laws and regulations are all clear, so it is natural to