1.營業(yè)執(zhí)照；

2.企業(yè)負責(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)。

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