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(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，比如說體外診斷試劑就屬于三類醫(yī)療器械，只有有相關(guān)證書，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，需要明確寫道可以銷售三類醫(yī)療器械。如果沒有，需要去工商局辦理增項(xiàng)。

3、銷售三類醫(yī)療器械，你必須要自己的庫(kù)房，庫(kù)房里需要設(shè)置冷藏庫(kù)，因?yàn)槿愥t(yī)療器械，是有保溫需要的，超過一定的溫度，就容易變質(zhì)影響產(chǎn)品質(zhì)量，很少有經(jīng)銷商有銷售三類醫(yī)療器械的資格。

necessary to be clearly stated that the third types of medical devices can be sold. If not, the need to go to the industrial and commercial bureau for additional items. 3, the sales of three types of medical devices, you must have their own warehouse, and the warehouse needs to set up cold storage, because the third class of medical devices, is the need for insulation, beyond a certain temperature, it is easy to deteriora