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</h1> <p> <span> 来源åQ?a href='http://www.ngjyjd.com/news/46.html'>http://www.ngjyjd.com/news/46.html</a> </span> <span> 旉™—´åQ?020-08-13 </span> </p> </div> <div class="yunu-infocontent-body"> <p> <p>          </p> <p> 8æœ?6日,国家药监局发布《医疗器械唯yi标识¾pȝ»Ÿè§„则》(以下½Ž€¿U°ã€Šè§„则》)åQŒæ—¨åœ¨è¯å½»è½å®žã€Šå›½åŠ¡é™¢åŠžå…¬åŽ…关于印发治理高值医用耗材攚w©æ–ÒŽ¡ˆçš„通知》(国办发ã€?019ã€?7åøP¼‰å’Œã€ŠåŒ»ç–—器械监督管理条例》,˜q›ä¸€æ­¥åŠ å¼ºåŒ»ç–—器械全生命周期的监督管理,创新监管模式。《规则》共18条,明确了医疗器械唯yi标识¾pȝ»Ÿå»ø™®¾çš„目的、适用对象、徏讑֎Ÿåˆ™ã€å„方职责和有关要求åQŒè‡ª2019òq?0æœ?日è“v正式施行ã€?</p> <p>        åŒÈ–—器械唯yi标识åQˆUnique Device IdentificationåQŒç®€¿U°UDIåQ‰æ˜¯åŒÈ–—器械产品的电子èín份证åQŒå”¯yi标识数据载体是储存或者传输医疗器械唯yi标识的媒介,唯yi标识数据库是储存åŒÈ–—器械唯yi标识的äñ”品标识与兌™”信息的数据库åQŒä¸‰è€…共同组成医疗器械唯yi标识¾pȝ»Ÿã€‚通过建立åŒÈ–—器械唯yi标识¾pȝ»ŸåQŒæœ‰åˆ©äºŽ˜qç”¨ä¿¡æ¯åŒ–手ŒDµå®žçŽ°å¯¹åŒÈ–—器械在生产、经营和使用各环节的快速、准¼‹®è¯†åˆ«ï¼Œæœ‰åˆ©äºŽå®žçŽîCñ”品监½Ž¡æ•°æ®çš„å…׃ín和整合,有利于创新监½Ž¡æ¨¡å¼ï¼Œæå‡ç›‘管效能åQŒæœ‰åˆ©äºŽåŠ å¼ºåŒÈ–—器械全生命周期管理,实现政府监管与社会治理相¾l“合åQŒåŞ成社会共æ²Èš„局面,˜q›ä¸€æ­¥æå‡å…¬ä¼—用械安全有效的保障水åã^ã€?</p> <div>       《规则》明¼‹®è§„定唯yi标识应与产品基本特征相关åQŒå¿…™åȝ¬¦åˆå”¯yi性、稳定性和可扩展性的原则。äؓ更好地落实发码机构相兌™Œè´£è¦æ±‚,《规则》规定发码机构应当äؓ中国境内的法人机构,òq¶è¦æ±‚发码机构应当向注册äº?备案人提供执行其标准的流½E‹åƈ指导实施åQŒå°†¾~–码标准上传臛_Œ»ç–—器械唯yi标识数据库åƈ动态维护,每年1æœ?1日前向国家药监局提交按照其标准创建的唯yi标识上一òq´åº¦çš„报告。《规则》规定国家药监局负责¾l„织建立åŒÈ–—器械唯yi标识数据库,供公众查询,数据的真实性、准¼‹®æ€§å’Œå®Œæ•´æ€§å¯¹äºŽåŒ»ç–—器械的正确识别臛_…³é‡è¦åQŒã€Šè§„则》强调了åŒÈ–—器械注册äº?备案人应当对数据的真实性和准确性负责ã€?br /> <div>        åŒÈ–—器械唯yi标识的ä­h值在于应用,各环节的有效应用是åŞ成监½Ž¡å¤§æ•°æ®çš„基¼‹€åQŒæ˜¯å®žæ–½äº’联¾|?监管、智慧监½Ž¡çš„重要途径和手ŒDµï¼Œå› æ­¤ã€Šè§„则》鼓励各相关方积极在åŒÈ–—器械生äñ”、经营和使用环节的管理中应用åŒÈ–—器械唯yi标识ã€?br />      ã€Šè§„则》的发布实施åQŒå°†˜q›ä¸€æ­¥è§„范医疗器械唯yi标识¾pȝ»Ÿå»ø™®¾åQŒåŠ å¼ºåŒ»ç–—器械全生命周期½Ž¡ç†åQŒæé«˜åŒ»ç–—器械识别的准确性和一致性,提升åŒÈ–—器械½Ž¡ç†æ°´åã^和效能,有力保障公众用械安全有效ã€?br /> </div> </div> <p> <img style="max-width:100%;" src="/uploads/image/20200820/20200820171614_5468.jpg" alt="" /> </p> </p> <p> <br/> </p> </div> <div class="yunu-infocontent-return"> 相关标签åQ? 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