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。

4、去工商局辦理增項，是需要帶著(zhù)工商局的工作人員來(lái)查看庫房的，你zui好把庫房收拾一下，領(lǐng)取《醫療器械經(jīng)營(yíng)企業(yè)許可申請表》并填寫(xiě)，并把企業(yè)相關(guān)資質(zhì)全部帶上，還需要帶上質(zhì)量人員的相關(guān)資料。

5、三類(lèi)醫療器械經(jīng)營(yíng)許可證，需要直接去市級人民政府食品藥品監督管理部門(mén)辦理，在接受資料后的30天內進(jìn)行審核，如果符合相關(guān)規定，就可以頒發(fā)三類(lèi)醫療器械經(jīng)營(yíng)許可證。

II medical devices 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 relevant certificates can such products be sold. 2. In order to apply for the business license of the third types of medical devices, there must be a relevant business license. In the column of the business scope on the general business license, it is 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 the third class of medical devices, you must have their own warehouse, and the warehouse needs to set up cold storage, because the third