1.營(yíng)業(yè)執(zhí)照,；

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

3.營(yíng)業(yè)場(chǎng)所證明和地理位置圖,。

辦理后的注意事項(xiàng)

1.醫(yī)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(zhǎng)的，醫(yī)療器械經(jīng)營(yíng)企業(yè)應(yīng)當(dāng)在有效期屆滿前6個(gè)月向原發(fā)證部門申請(qǐng)延期《醫(yī)療器械經(jīng)營(yíng)許可證》；

2.具有符合醫(yī)療器械經(jīng)營(yíng)質(zhì)量管理要求的計(jì)算機(jī)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(yíng)業(yè)的,，應(yīng)當(dāng)提前向所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門書面報(bào)告,，經(jīng)核實(shí)符合要求后方可恢復(fù)營(yíng)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