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。

nal title certificate of the person in charge of the enterprise, the inspection personnel and the technical personnel; 3. Business site certificate and geographical location map. Matters needing attention after handling 1. The validity period of the medical device business license is only 5 years. If the period of validity needs to be extended, the medical device trading enterprise shall apply to the original license issuing department for the extension of the Medical Device Business License 6 months before the expiration of the validity period; 2. Have a computer information management system that meets the business management re of medical devices to ensure the traceability of products; 3. A sales record system and a management self-inspection system should be established; 4. If