三類醫(yī)療器械經(jīng)營許可證辦理所需大致資料:

1、企業(yè)經(jīng)營執(zhí)照;2、企業(yè)負(fù)責(zé)人以及質(zhì)檢人員和技術(shù)人員的身份、學(xué)歷、職稱證明;3、經(jīng)營場所證明以及地理位置圖。

三類醫(yī)療器械經(jīng)營許可證辦理之后需要明確的幾個(gè)注意事項(xiàng)

1、醫(yī)療器械經(jīng)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(jīng)營企業(yè)應(yīng)當(dāng)在有效期屆滿6個(gè)月前，向原發(fā)證部門提出《醫(yī)療器械經(jīng)營許可證》延續(xù)申請。

2、應(yīng)當(dāng)具有符合醫(yī)療器械經(jīng)營質(zhì)量管理要求的計(jì)算機(jī)信息管理系統(tǒng)，保證經(jīng)營產(chǎn)品的可追溯。

3、應(yīng)當(dāng)建立銷售記錄制度和建立質(zhì)量管理自查制度。

4、自行停業(yè)一年以上，重新經(jīng)營時(shí)，應(yīng)當(dāng)提前書面報(bào)告所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門，經(jīng)核查符合要求后方可恢復(fù)經(jīng)營。

關(guān)于在京辦理三類醫(yī)療器械經(jīng)營許可證的更多問題，歡迎私信小編，

 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 expiration, the medical device trading enterprise shall, 6 months before the expiration of the validity period, apply to the original license issuing department for the renewal of the Medical Device Business License. 2. It shall have a computer information management system that meets the re of business management of medical devices to ensure the traceability of business products. 3. A sales record system and a management self-inspection system shall be established. 4. When suspending business for more than one year and re-operating, it shall submit a written report i