有效期需要延長的,醫(yī)療器械經(jīng)營企業(yè)應當在有效期屆滿前6個月向原發(fā)證部"/>
醫(yī)療器械三類: | 注冊 |
醫(yī)療器械二類: | 注冊 |
注冊公司: | 網(wǎng)絡銷售備案 |
單價: | 面議 |
發(fā)貨期限: | 自買家付款之日起 天內(nèi)發(fā)貨 |
所在地: | 直轄市 北京 北京海淀 |
有效期至: | 長期有效 |
發(fā)布時間: | 2023-11-24 05:28 |
最后更新: | 2023-11-24 05:28 |
瀏覽次數(shù): | 58 |
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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,應當提前向所在地設區(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營業(yè)。
cal 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 the company closes business by itself for more than