經(jīng)營企業(yè)要知曉辦理三類醫(yī)療器械經(jīng)營許可證需要準(zhǔn)備哪些資料。

(1)提交醫(yī)療器械經(jīng)營企業(yè)許可證申請表，法定代表人簽字或加蓋企業(yè)公章；

(2)工商行政管理部門出具的企業(yè)名稱預(yù)核準(zhǔn)證明文件或《營業(yè)執(zhí)照》復(fù)印件和校驗(yàn)原件；

(3)企業(yè)質(zhì)量管理負(fù)責(zé)人的身份證、學(xué)歷或者職稱證明復(fù)印件及個(gè)人簡歷；質(zhì)量管理人員的身份證、學(xué)歷或者職稱證明復(fù)印件；

(4)經(jīng)營場所、倉庫的地理位置圖、平面圖（注明面積）、房屋產(chǎn)權(quán)證明或者租賃協(xié)議復(fù)印件；

(5)企業(yè)產(chǎn)品質(zhì)量管理制度文件及儲存設(shè)施、設(shè)備目錄。

(6）對于辦理三類醫(yī)療器械經(jīng)營許可證內(nèi)容包含有需要冷藏的藥品時(shí)，企業(yè)具備的運(yùn)輸裝備、倉儲設(shè)施設(shè)備情況表。

、第三類醫(yī)療器械經(jīng)營許可證怎么辦理

（1）申請人提交申請資料到相關(guān)部門；

（2）相關(guān)部門受理申請人的申請；

（3）到實(shí)際場地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核；

（4）準(zhǔn)予頒發(fā)三類醫(yī)療器械許可證。

t. (1) Submit the application form for the license of the medical device operating enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) A copy of the pre-approval certificate of enterprise name or the business License issued by the administrative department for industry and commerce; (3) A copy of the id card, educational background or professional title certificate and personal resume of the management manager of the enterprise; a copy of the ID card, educational background or professional title certificate of the management personnel; (4) The business site, warehouse of