申請辦理三類(lèi)醫療器械許可證必須提前準備的原材料

（1）企業(yè)營(yíng)業(yè)執照；

（2）公司章；

（3）房屋產(chǎn)權證明、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(yíng)地平面設計圖，倉庫平面設計圖。

申請辦理三類(lèi)醫療器械許可證的規定

（1）場(chǎng)所和倉庫總面積規定：與經(jīng)營(yíng)地企業(yè)規模相一致。

（2）品質(zhì)管理員規定：專(zhuān)科本科以上學(xué)歷或是初級左右專(zhuān)業(yè)職稱(chēng)，另外理應具備3年左右醫療器械經(jīng)營(yíng)品質(zhì)管理方面親身經(jīng)歷。

（3）品質(zhì)管理員技術(shù)專(zhuān)業(yè)規定：醫療機械有關(guān)技術(shù)專(zhuān)業(yè)，例如：醫藥學(xué)、藥理學(xué)、生物技術(shù)、護理專(zhuān)業(yè)等。

三類(lèi)醫療器械許可證怎么樣辦

充分考慮醫藥行業(yè)相關(guān)法律法規及管控規定許多 ，跨專(zhuān)業(yè)工作人員沒(méi)辦法申請辦理取得成功或產(chǎn)生后遺癥，

提議找醫療器械專(zhuān)業(yè)第三方服務(wù)項目組織申請辦理。由于第三方資源廣，基礎的法律法規都一清二楚，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