許可證的辦理?xiàng)l件

根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》第三十一條的規(guī)定，從事第三類(lèi)醫(yī)療器械業(yè)務(wù)的，經(jīng)營(yíng)企業(yè)應(yīng)當(dāng)向所在地設(shè)區(qū)的市級(jí)人民政府食品藥品監(jiān)督管理部門(mén)申請(qǐng)經(jīng)營(yíng)許可。

1.有與經(jīng)營(yíng)范圍相適應(yīng)的營(yíng)業(yè)場(chǎng)所和倉(cāng)庫(kù)，并有特定的面積要求；

2.具有國(guó)家認(rèn)可的專(zhuān)門(mén)從事產(chǎn)品經(jīng)營(yíng)的在職人員；

3、應(yīng)有具有中專(zhuān)以上學(xué)歷的與產(chǎn)品管理相關(guān)的技術(shù)人員；

4.具有與所經(jīng)營(yíng)的醫(yī)療器械相適應(yīng)的質(zhì)量管理體系。

許可證的所需材料

1.營(yíng)業(yè)執(zhí)照；

2.企業(yè)負(fù)責(zé)人、質(zhì)量檢驗(yàn)人員和技術(shù)人員的身份、學(xué)歷和職稱(chēng)證明；

3.營(yíng)業(yè)場(chǎng)所證明和地理位置圖。

辦理后的注意事項(xiàng)

Regulations on the Supervision and Administration of Medical Devices, those engaged in the third class of medical device business shall apply for a business license to the food and drug supervisory and administrative department of the people's government of the city divided into districts where it is located. 1. Having business premises and warehouses suitable for the business scope, and having specific area re; 2. On-the-job personnel recognized by the state and specialized in product management; 3. There should be technical personnel related to product management with a technical secondary school education or above; 4. Have a manageme