依據《醫(yī)療器械監(jiān)督管理條例》，第三類醫(yī)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(yī)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。

opt 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