依據《醫療器械監督管理條例》，第三類(lèi)醫療器械是具備較高危，必須采用非常對策嚴控管理方法以確保其安全性、合理的醫療機械。例如普遍的注射器、注射針、靜脈留置針、心臟支架、麻醉機、CT、磁共振等。

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)，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。

nery with high risk, which must adopt extraordinary countermeasures and strict control management methods to ensure its safety and rationality. For example, common syringes, injection needles, intravenous indwelling needles, cardiac stents, anesthesia, machine, CT, magnetic resonance, etc. Raw materials that must be prepared in advance when applying for the Class III medical device license (1) Enterprise business license; (2) Company seal; (3) Property right certificate and lease agreement; (4) Identity of legal representative, principal person in charge, manager, graduation certificate and other certification materials; (5) Operation floor plan design drawing, warehouse floor plan design drawing. Provisions on applying for a class III medical device license (1) The total area of the place and warehouse provisions: 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 m