依據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》，第三類醫(yī)療器械是具備較高危，必須采用非常對(duì)策嚴(yán)控管理方法以確保其安全性、合理的醫(yī)療機(jī)械。例如普遍的注射器、注射針、靜脈留置針、心臟支架、麻醉機(jī)、CT、磁共振等。

申請(qǐng)辦理三類醫(yī)療器械許可證必須提前準(zhǔn)備的原材料

（1）企業(yè)營(yíng)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(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：?？票究埔陨蠈W(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。

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