許可證的辦理條件

根據《醫療器械監督管理條例》第三十一條的規定，從事第三類(lèi)醫療器械業(yè)務(wù)的，經(jīng)營(yíng)企業(yè)應當向所在地設區的市級人民政府食品藥品監督管理部門(mén)申請經(jīng)營(yíng)許可。

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

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

3、應有具有中專(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)的醫療器械相適應的質(zhì)量管理體系。

許可證的所需材料

1.營(yíng)業(yè)執照；

2.企業(yè)負責人、質(zhì)量檢驗人員和技術(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

ations 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 management system suitable for the medical devices it operates. Materials required for the permit 1. Bus