（3）房屋產(chǎn)權(quán)證明、租賃協(xié)議；

（4）法定代表人、主要負(fù)責(zé)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(shè)計(jì)圖，倉(cāng)庫(kù)平面設(shè)計(jì)圖。

申請(qǐng)辦理三類醫(yī)療器械許可證的規(guī)定

（1）場(chǎng)所和倉(cāng)庫(kù)總面積規(guī)定：與經(jīng)營(yíng)地企業(yè)規(guī)模相一致。

（2）品質(zhì)管理員規(guī)定：專科本科以上學(xué)歷或是初級(jí)左右專業(yè)職稱，理應(yīng)具備3年左右醫(yī)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)專業(yè)規(guī)定：醫(yī)療機(jī)械有關(guān)技術(shù)專業(yè)，例如：醫(yī)藥學(xué)、藥理學(xué)、生物技術(shù)、護(hù)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(qǐng)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(wù)項(xiàng)目組織申請(qǐng)辦理。由于第三方資源廣，基礎(chǔ)的法律法規(guī)都一清二楚，提前準(zhǔn)備材料自然游刃有余。

technology, 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 prepare materials in advance with ease.