經(jīng)營(yíng)企業(yè)要知曉辦理三類(lèi)醫療器械經(jīng)營(yíng)許可證需要準備哪些資料。

(1)提交醫療器械經(jīng)營(yíng)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(mén)出具的企業(yè)名稱(chēng)預核準證明文件或《營(yíng)業(yè)執照》復印件和校驗原件；

(3)企業(yè)質(zhì)量管理負責人的身份證、學(xué)歷或者職稱(chēng)證明復印件及個(gè)人簡(jiǎn)歷；質(zhì)量管理人員的身份證、學(xué)歷或者職稱(chēng)證明復印件；

(4)經(jīng)營(yíng)場(chǎng)所、倉庫的地理位置圖、平面圖（注明面積）、房屋產(chǎn)權證明或者租賃協(xié)議復印件；

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

(6）對于辦理三類(lèi)醫療器械經(jīng)營(yíng)許可證內容包含有需要冷藏的藥品時(shí)，企業(yè)具備的運輸裝備、倉儲設施設備情況表。

、第三類(lèi)醫療器械經(jīng)營(yíng)許可證怎么辦理

（1）申請人提交申請資料到相關(guān)部門(mén)；

（2）相關(guān)部門(mén)受理申請人的申請；

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

（4）準予頒發(fā)三類(lèi)醫療器械許可證。

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 the geographical location plan, plan (indicating the area), the property right certificate or lease copy of the agreement; (5) Enterprise product management system documents and catalogue of storage facilities and e (6) Table of transportation e and storage facilities and e available by the enterprise when the contents of the business license contains drugs that need to be refrigerated. , The third type of