許可證的辦理條件

根據(jù)《醫(yī)療器械監(jiān)督管理條例》第三十一條的規(guī)定，從事第三類醫(yī)療器械業(yè)務的，經(jīng)營企業(yè)應當向所在地設區(qū)的市級人民政府食品藥品監(jiān)督管理部門申請經(jīng)營許可。

1.有與經(jīng)營范圍相適應的營業(yè)場所和倉庫，并有特定的面積要求；

2.具有國家認可的專門從事產(chǎn)品經(jīng)營的在職人員；

3、應有具有中專以上學歷的與產(chǎn)品管理相關的技術人員；

4.具有與所經(jīng)營的醫(yī)療器械相適應的質量管理體系。

許可證的所需材料

1.營業(yè)執(zhí)照；

2.企業(yè)負責人、質量檢驗人員和技術人員的身份、學歷和職稱證明；

3.營業(yè)場所證明和地理位置圖。

辦理后的注意事項

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