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。

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,