1.營業(yè)執(zhí)照；

2.企業(yè)負(fù)責(zé)人、質(zhì)量檢驗人員和技術(shù)人員的身份、學(xué)歷和職稱證明；

3.營業(yè)場所證明和地理位置圖。

辦理后的注意事項

1.醫(yī)療器械經(jīng)營許可證的有效期只有5年。有效期需要延長的，醫(yī)療器械經(jīng)營企業(yè)應(yīng)當(dāng)在有效期屆滿前6個月向原發(fā)證部門申請延期《醫(yī)療器械經(jīng)營許可證》；

2.具有符合醫(yī)療器械經(jīng)營質(zhì)量管理要求的計算機信息管理系統(tǒng)，確保產(chǎn)品的可追溯性；

3.應(yīng)建立銷售記錄制度和質(zhì)量管理自查制度；

4.自行停業(yè)一年以上又重新營業(yè)的，應(yīng)當(dāng)提前向所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門書面報告，經(jīng)核實符合要求后方可恢復(fù)營業(yè)。

edical devices 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