1、醫療器械經(jīng)營(yíng)許可證的有效期只有5年。有效期屆滿(mǎn)需要延續的，醫療器械經(jīng)營(yíng)企業(yè)應當在有效期屆滿(mǎn)6個(gè)月前，向原發(fā)證部門(mén)提出《醫療器械經(jīng)營(yíng)許可證》延續申請。

2、應當具有符合醫療器械經(jīng)營(yíng)質(zhì)量管理要求的計算機信息管理系統，保證經(jīng)營(yíng)產(chǎn)品的可追溯。

3、應當建立銷(xiāo)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)，應當提前書(shū)面報告所在地設區的市級食品藥品監督管理部門(mén)，經(jīng)核查符合要求后方可恢復經(jīng)營(yíng)。

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



一、三類(lèi)醫療器械經(jīng)營(yíng)許可證如何辦理

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

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

3、銷(xiāo)售三類(lèi)醫療器械，你必須要自己的庫房，庫房里需要設置冷藏庫，因為三類(lèi)醫療器械，是有保溫需要的，超過(guò)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(xiāo)商有銷(xiāo)售三類(lèi)醫療器械的資格。

 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, and shall resume business only after checking that it meets the re. about more about the third class of medical device business license in Beijing, welcome private messages, how to handle the first and third class of medical device business license 1. Many distributors of drugs or medical devices cannot be sold without the business license of third class medical devices. For example, in vitro diagnostic reagents belong to third class medical devices, and only with releva