1.有與經(jīng)營(yíng)范圍相適應(yīng)的營(yíng)業(yè)場(chǎng)所和倉(cāng)庫(kù)，并有特定的面積要求；

2.具有國(guó)家認(rèn)可的專門(mén)從事產(chǎn)品經(jīng)營(yíng)的在職人員；

3、應(yīng)有具有中專以上學(xué)歷的與產(chǎn)品管理相關(guān)的技術(shù)人員；

4.具有與所經(jīng)營(yíng)的醫(yī)療器械相適應(yīng)的質(zhì)量管理體系。

許可證的所需材料

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(mén)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；

anagement system suitable for the medical devices it operates. Materials required for the permit 1. Business license; 2. The identity, educational background and professional 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 managemen