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）房屋產權證明、租賃協(xié)議；

（4）法定代表人、主要負責人、品質管理員的身份、畢業(yè)證等證明材料；

（5）經營地平面設計圖，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：與經營地企業(yè)規(guī)模相一致。

（2）品質管理員規(guī)定：?？票究埔陨蠈W歷或是初級左右專業(yè)職稱，理應具備3年左右醫(yī)療器械經營品質管理方面親身經歷。

（3）品質管理員技術專業(yè)規(guī)定：醫(yī)療機械有關技術專業(yè)，例如：醫(yī)藥學、藥理學、生物技術、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