2.具有國家認可的專門從事產品經營的在職人員；

3、應有具有中專以上學歷的與產品管理相關的技術人員；

4.具有與所經營的醫(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

1.醫(yī)療器械經營許可證的有效期只有5年。有效期需要延長的，醫(yī)療器械經營企業(yè)應當在有效期屆滿前6個月向原發(fā)證部門申請延期《醫(yī)療器械經營許可證》；

2.具有符合醫(yī)療器械經營質量管理要求的計算機信息管理系統(tǒng)，確保產品的可追

ed 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. Business license; 2. The identity, educational background and professional title certificate of the person in charge of the enterprise, the inspection personnel and the technical personnel; 3. Business site certificate and geographical location map. Matters needing attention after handling 1. The validity period of the medical device business license is only 5 years. If the period of validity needs to be extended, the medical device trading enterprise shall apply to the original