許可證的所需材料

1.營(yíng)業(yè)執照；

2.企業(yè)負責人、質(zhì)量檢驗人員和技術(shù)人員的身份、學(xué)歷和職稱(chēng)證明；

3.營(yíng)業(yè)場(chǎng)所證明和地理位置圖。

辦理后的注意事項

1.醫療器械經(jīng)營(yíng)許可證的有效期只有5年。有效期需要延長(cháng)的，醫療器械經(jīng)營(yíng)企業(yè)應當在有效期屆滿(mǎn)前6個(gè)月向原發(fā)證部門(mén)申請延期《醫療器械經(jīng)營(yíng)許可證》；

2.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，確保產(chǎn)品的可追溯性；

3.應建立銷(xiāo)售記錄制度和質(zhì)量管理自查制度；

4.自行停業(yè)一年以上又重新?tīng)I業(yè)的，應當提前向所在地設區的市級食品藥品監督管理部門(mén)書(shū)面報告，經(jīng)核實(shí)符合要求后方可恢復營(yíng)業(yè)。

s to ensure the traceability of products; 3. A sales record system and a management self-inspection system should be established; 4. If the company stops business for more than one year and does business again, it shall make a written report in advance to the food and drug supervisory and administrative department of the city divided into districts is located, and resume business only after verifying that it meets the re