證，根據相關法律規(guī)定，國家食品藥品監(jiān)督管理局逐步推行醫(yī)療器械經營質量規(guī)范管理制度。醫(yī)療器械經營質量管理規(guī)范由國家食品藥品監(jiān)管管理局組織制定。

三類醫(yī)療器械經營許可證辦理所需大致資料:

1、企業(yè)經營執(zhí)照;2、企業(yè)負責人以及質檢人員和技術人員的身份、學歷、職稱證明;3、經營場所證明以及地理位置圖。

三類醫(yī)療器械經營許可證辦理之后需要明確的幾個注意事項

1、醫(yī)療器械經營許可證的有效期只有5年。有效期屆滿需要延續(xù)的，醫(yī)療器械經營企業(yè)應當在有效期屆滿6個月前，向原發(fā)證部門提出《醫(yī)療器械經營許可證》延續(xù)申請。

2、應當具有符合醫(yī)療器械經營質量管理要求的計算機信息管理系統(tǒng)，保證經營產品的可追溯。

3、應當建立銷售記錄制度和建立質量管理自查制度。

4、自行停業(yè)一年以上，重新經營時，應當提前書面報告所在地設區(qū)的市級食品藥品監(jiān)督管理部門，經核查符合要求后方可恢復經營。

關于在京辦理三類醫(yī)療器械經營許可證的更多問題，歡迎私信小編，

s and regulations, the State Food and Drug Administration has gradually implemented the standard management system of medical device business. The management standards for medical devices shall be formulated by the State Food and Drug Administration. General information required for handling the business license of Class III medical devices: 1. Business license; 2. Certificate of identity, educational background and professional title of the person in charge of the enterprise, inspection personnel and technical personnel; 3. Certificate of business site and geographical location map. Several matters needing attention should be clarified after handling the business license of class III medical devices 1. The validity period of the medical device business license is only 5 years. If the term of validity needs to be extended upon ex