1,、醫(yī)療器械經(jīng)營(yíng)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(yíng)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(mén)提出《醫(yī)療器械經(jīng)營(yíng)許可證》延續(xù)申請(qǐng)。

2,、應(yīng)當(dāng)具有符合醫(yī)療器械經(jīng)營(yíng)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(yíng)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(yíng)時(shí),，應(yīng)當(dāng)提前書(shū)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(mén)，經(jīng)核查符合要求后方可恢復(fù)經(jīng)營(yíng),。

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



一,、三類醫(yī)療器械經(jīng)營(yíng)許可證如何辦理

1,、很多藥品或者醫(yī)療器械的經(jīng)銷商，如果沒(méi)有三類醫(yī)療器械經(jīng)營(yíng)許可證,，很多產(chǎn)品就不能賣,，比如說(shuō)體外診斷試劑就屬于三類醫(yī)療器械，只有有相關(guān)證書(shū),，才能銷售這種產(chǎn)品,。

2,、要辦理三類醫(yī)療器械經(jīng)營(yíng)許可證，必須有相關(guān)的營(yíng)業(yè)執(zhí)照,，一般營(yíng)業(yè)執(zhí)照上的經(jīng)營(yíng)范圍這一欄,，需要明確寫(xiě)道可以銷售三類醫(yī)療器械。如果沒(méi)有,，需要去工商局辦理增項(xiàng),。

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 in advance to the food and drug supervisory and administrative department of the city where it is located,