1.營業執照；

2.企業負責人、質量檢驗人員和技術人員的身份、學歷和職稱證明；

3.營業場所證明和地理位置圖。

辦理后的注意事項

1.醫療器械經營許可證的有效期只有5年。有效期需要延長的，醫療器械經營企業應當在有效期屆滿前6個月向原發證部門申請延期《醫療器械經營許可證》；

2.具有符合醫療器械經營質量管理要求的計算機信息管理系統，確保產品的可追溯性；

3.應建立銷售記錄制度和質量管理自查制度；

4.自行停業一年以上又重新營業的，應當提前向所在地設區的市級食品藥品監督管理部門書面報告，經核實符合要求后方可恢復營業。

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