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style="font-size:14px;">yi</span><span style="font-size:14px;">标识ç”׃ñ”品标识和生äñ”标识¾l„成åQŒäñ”品标识是识别注册äº?/span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案人、医疗器械型可‚§„格和包装çš?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">代码åQŒæ˜¯ä»Žæ•°æ®åº“获取åŒÈ–—器械相关信息çš?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">关键å­?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">åQŒæ˜¯</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识的必™å»éƒ¨åˆ†ï¼›ç”Ÿäñ”标识包括与生产过½E‹ç›¸å…³çš„信息åQŒåŒ…括äñ”品批受÷€åºåˆ—号、生产日期和失效日期½{‰ï¼Œå¯ä¸Žäº§å“æ ‡è¯†è”合使用åQŒæ»¡­‘›_Œ»ç–—器械流通和使用环节¾_„¡»†åŒ–识别和记录的需求ã€?/span><br /> <span> </span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识具备</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性、稳定性和可扩展性的原则ã€?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性是首要原则åQŒæ˜¯¼‹®ä¿äº§å“¾_„¡¡®è¯†åˆ«çš„基¼‹€åQŒæ˜¯</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识发挥功能的核心原则。由于医疗器æ¢îCñ”品的复杂性,</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性应当与产品识别要求ç›æ€¸€è‡ß_¼Œå¯¹äºŽç›¸åŒç‰¹å¾çš„医疗器梎ͼŒ</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性应当指向单个规格型号äñ”品;对于按照æ‰ÒŽ¬¡ç”Ÿäñ”控制的äñ”品,</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性指向同æ‰ÒŽ¬¡äº§å“åQ›è€Œå¯¹äºŽé‡‡ç”¨åºåˆ—号生äñ”控制的医疗器梎ͼŒ</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性应当指向单个äñ”品ã€?/span><br /> <span style="font-size:14px;"> ½E›_®šæ€§æ˜¯æŒ?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识一旦分配给åŒÈ–—器械产品åQŒåªè¦å…¶åŸºæœ¬ç‰¹å¾æ²¡æœ‰å‘生变化åQŒäñ”品标识就应该保持不变。当åŒÈ–—器械停止销售、ä‹É用时åQŒå…¶äº§å“æ ‡è¯†ä¸å¾—用于其他åŒÈ–—器械åQ›é‡æ–°é”€å”®ã€ä‹É用时åQŒå¯ä½¿ç”¨åŽŸäñ”品标识ã€?/span><br /> <span style="font-size:14px;"> 可扩展性是æŒ?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识应当与监½Ž¡è¦æ±‚和实际应用不断发展盔R€‚应åQ?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yiâ€?/span><span style="font-size:14px;">一词åƈ不意味着对单个äñ”品进行序列号化管理,åœ?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识中,生äñ”标识可以和äñ”品标识联合ä‹É用,实现规格型号、批‹Æ¡å’Œå•ä¸ªäº§å“ä¸‰ä¸ªå±‚次çš?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性,从而满­‘›_½“前和未来对医疗器械的识别需求ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 二、äؓ什么要å»ø™®¾åŒÈ–—器械</span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识¾pȝ»ŸåQ?/span> </b><br /> <span style="font-size:14px;"> åŒÈ–—技术、药品、医疗器械是构成åŒÈ–—服务体系的三大支柱,åŒÈ–—器械涉及声、光、电、磁、图像、材料、力学等行业和近百个专业学科åQŒæ˜¯å›½é™…公认的高新技术äñ”业,å…ähœ‰é«˜æŠ€æœ¯å¯†é›†ã€å­¦¿U‘交叉广泛、技术集成融合等特点åQŒä»£è¡¨ç€ä¸€ä¸ªå›½å®‰™«˜æ–°æŠ€æœ¯çš„¾l¼åˆå®žåŠ›ã€‚è¿‘òq´æ¥åQŒåŒ»ç–—器æ¢îCñ”业发展迅猛,新技术、新产品层出不穷åQŒäñ”品多æ äh€§ã€å¤æ‚性程度不断提升,åŒÈ–—器械在流通ä‹É用环节无码或者一物多码现象普遍,严重影响了医疗器械生产、流通、ä‹É用等各环节对åŒÈ–—器械的精准识别,难以实现有效监督和管理ã€?/span><br /> <span style="font-size:14px;"> åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQ?/span><span style="font-size:14px;">Unique Device Identification</span><span style="font-size:14px;">åQŒç®€¿U?/span><span style="font-size:14px;">UDI</span><span style="font-size:14px;">åQ‰æ˜¯åŒÈ–—器械的èín份证åQŒåŒ»ç–—器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿç”±åŒ»ç–—器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识、数据蝲体和数据库组成。äؓ每个åŒÈ–—器械赋予íw«ä†¾è¯ï¼Œå®žçŽ°ç”Ÿäñ”、经营、ä‹É用各环节的透明化、可视化åQŒæå‡äñ”品的可追溯性,是医疗器械监½Ž¡æ‰‹ŒDµåˆ›æ–°å’Œç›‘管效能提升的重要抓手,对严守医疗器械安全底¾Uѝ€åŠ©åŠ›åŒ»ç–—器æ¢îCñ”业高质量发展都将起到¿U¯æžä½œç”¨ã€‚因此,我国åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿå»ø™®¾å·¥ä½œæ€¥éœ€å¼€å±•ã€?/span><br /> <span style="font-size:14px;"> åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识是国际医疗器械监½Ž¡é¢†åŸŸå…³æ³¨çš„焦点和热点,</span><span style="font-size:14px;">2013</span><span style="font-size:14px;">òqß_¼Œå›½é™…åŒÈ–—器械监管机构论坛åQ?/span><span style="font-size:14px;">IMDRF</span><span style="font-size:14px;">åQ‰å‘布医疗器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»ŸæŒ‡å—。同òqß_¼Œ¾ŸŽå›½å‘布åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿæ³•è§„åQŒè¦æ±‚利ç”?/span><span style="font-size:14px;">7</span><span style="font-size:14px;">òq´æ—¶é—´å…¨é¢å®žæ–½åŒ»ç–—器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识ã€?/span><span style="font-size:14px;">2017</span><span style="font-size:14px;">òqß_¼Œ‹Æ§ç›Ÿç«‹æ³•è¦æ±‚实施åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒæ—¥æœ¬ã€æ¾³å¤§åˆ©äºšã€é˜¿æ ¹å­h½{‰å›½å®¶ä¹Ÿç›¸ç‘ô开展相兛_·¥ä½œï¼Œå…¨çƒåŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识工作不断推进ã€?/span><br /> <span> </span><span style="font-size:14px;">2012</span><span style="font-size:14px;">òqß_¼Œå›½åŠ¡é™¢å°å‘ã€?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">十二äº?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">国家药品安全规划》,要求</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">启动高风险医疗器械国家统一¾~–码工作</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">ã€?/span><span style="font-size:14px;">2016</span><span style="font-size:14px;">òqß_¼Œå›½åŠ¡é™¢å°å‘ã€?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">十三äº?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">国家药品安全规划》,要求</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">构徏åŒÈ–—器械¾~–码体系åQŒåˆ¶å®šåŒ»ç–—器械编码规åˆ?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">ã€?/span><span style="font-size:14px;">2019</span><span style="font-size:14px;">òqß_¼Œå›½åŠ¡é™¢åŠžå…¬åŽ…印发《深化医药卫生体制改é?/span><span style="font-size:14px;">2019</span><span style="font-size:14px;">òq´é‡ç‚¹å·¥ä½œä“Q务》,要求</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">制定åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿè§„则</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">åQŒç»ä¸­å¤®å…¨é¢æ·±åŒ–攚w©å§”员会第八次会议审议通过åQŒç”±å›½åŠ¡é™¢åŠžå…¬åŽ…印发的《治理高值医用耗材攚w©æ–ÒŽ¡ˆã€‹ä¸­åQŒæ˜Ž¼‹®æå‡?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">制定åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿè§„则</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">ã€?/span><span style="font-size:14px;">2019</span><span style="font-size:14px;">òq?/span><span style="font-size:14px;">7</span><span style="font-size:14px;">月,国家药监局会同国家卫生健康委联合印发《医疗器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿè¯•ç‚¹å·¥ä½œæ–ÒŽ¡ˆã€‹ï¼Œæ‹‰å¼€æˆ‘国åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿå»ø™®¾åºå¹•ã€?/span><br /> <span> </span><b><span style="font-size:14px;">三、徏讑֌»ç–—器æ¢?/span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识¾pȝ»Ÿæœ‰ä»€ä¹ˆé‡è¦æ„ä¹‰ï¼Ÿ</span> </b><b><br /> </b><span style="font-size:14px;"> 通过建立åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»ŸåQŒæœ‰åˆ©äºŽå®žçŽ°ç›‘管数据的整合和å…׃ínåQŒåˆ›æ–°ç›‘½Ž¡æ¨¡å¼ï¼Œæå‡ç›‘管效能åQŒåŠ å¼ºåŒ»ç–—器械全生命周期½Ž¡ç†åQŒå‡€åŒ–市场、优化营商环境,实现政府监管与社会治理相¾l“合åQŒåŞ成社会共æ²Èš„局面,助力产业转型升çñ”和健康发展,为公众提供更加安全高效的åŒÈ–—服务åQŒå¢žå¼ÞZh民群众的获得感ã€?/span><br /> <span style="font-size:14px;"> 从äñ”业角度看åQŒå¯¹äºŽåŒ»ç–—器械生产企业,利用</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识有助于提升企业信息化½Ž¡ç†æ°´åã^åQŒå¾ç«‹äñ”品追溯体¾p»ï¼ŒåŠ å¼ºè¡Œä¸šè‡ªå¾‹åQŒæå‡ä¼ä¸šç®¡ç†æ•ˆèƒ½ï¼ŒåŠ©æŽ¨åŒÈ–—器械产业高质量发展。对于医疗器械经营企业,利用</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒå¯å»ºç«‹½W¦åˆçŽîC»£åŒ–的物流体系åQŒå®žçŽ°åŒ»ç–—器æ¢îC¾›åº”链的透明化、可视化、智能化。对于医疗机构,利用</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒæœ‰åˆ©äºŽå‡å°‘用械差错åQŒæå‡é™¢å†…耗材½Ž¡ç†æ°´åã^åQŒç»´æŠ¤æ‚£è€…安全ã€?/span><br /> <span style="font-size:14px;"> 从政府管理角度看åQŒå¯¹äºŽåŒ»ç–—器械监½Ž¡ï¼Œåˆ©ç”¨</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒå¯æž„徏åŒÈ–—器械监管大数据,实现对医疗器械来源可查、去向可˜q½ã€è´£ä»Õd¯½IӞ¼Œå®žçŽ°æ™ºæ…§ç›‘管。对于卫生行政管理部门,利用</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒå¯å¼ºåŒ–对医疗用械行为的规范化管理,推动建立健康åŒÈ–—大数据,提高卫生½Ž¡ç†æ•ˆçŽ‡åQŒåŠ©åŠ›å¥åº·ä¸­å›½æˆ˜ç•¥ã€‚对于医保部门,有助于在采购招标中精准识别医疗器梎ͼŒæŽ¨åŠ¨å®žçŽ°¾l“算透明化,打击‹Æø™¯ˆå’Œæ»¥ç”¨è¡Œä¸ºã€?/span><br /> <span style="font-size:14px;"> 从公众角度看åQŒé€šè¿‡ä¿¡æ¯å…¬å¼€å’Œæ•°æ®å…±äº«ï¼Œè®©æ¶ˆè´¹è€…放心ä‹É用、明白消费,有效¾l´æŠ¤æ¶ˆè´¹è€…合法权益ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 四、医疗器æ¢?/span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识实施遵åó@哪些原则åQ?/span> </b><b><br /> </b><span style="font-size:14px;"> 《医疗器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿè§„则》(以下½Ž€¿U°ã€Šè§„则》)要求åQ?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿå»ø™®¾åº”当¿U¯æžå€Ÿé‰´å›½é™…标准åQŒéµå¾ªæ”¿åºœå¼•å¯¹{€ä¼ä¸šè½å®žã€ç»Ÿ½{ҎŽ¨˜q›ã€åˆ†å¸ƒå®žæ–½çš„原则。äؓ更好åœîC¿ƒ˜q›å›½é™…交‹¹å’Œå›½é™…贸易åQŒä¼˜åŒ–营商环境,我国</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»Ÿå»ø™®¾å€Ÿé‰´äº†å›½é™…通行的原则和标准。徏ç«?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识¾pȝ»ŸåQŒæ”¿åºœè“v引导作用åQŒæ³¨å†Œäh</span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案äºÞZ½œä¸ºç¬¬ä¸€è´£ä“Qäºø™´Ÿè´£è½å®žï¼Œ¿U¯æžåº”用</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识提升产品质量和企业管理水òqŸë€‚由于医疗器械的多样性和复杂性,分步实施</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识是国际通行做法åQŒæˆ‘国医疗器械按照风险等¾U§å®žè¡Œåˆ†¾cȝ®¡ç†ï¼Œåœ¨å€Ÿé‰´å›½é™…</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识相关实践¾léªŒçš„基¼‹€ä¸Šï¼Œ¾l“合我国åŒÈ–—器械产业和监½Ž¡å®žé™…,制定了分步实施的政策åQŒç›¸è¾ƒäºŽ¾ŸŽæ¬§åQŒæˆ‘国实æ–?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识增加了试点环节,以部分高风险æ¤?/span><span style="font-size:14px;">/</span><span style="font-size:14px;">介入åŒÈ–—器械ä¸ÞZ¸»åQŒè¦†ç›–范围更ž®ï¼Œ¼‹®ä¿è§„则½EÏx­¥æŽ¨è¿›ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 五、如何实çŽ?/span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识数据汇聚和共享?</span> </b><b><br /> </b><span style="font-size:14px;"> åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识数据汇聚和共享通过åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识数据库实玎ͼŒè¯¥æ•°æ®åº“由国家药品监督管理局¾l„织å»ø™®¾åQŒç”±æ³¨å†Œäº?/span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案人将</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识的äñ”品标识及兌™”信息按照相关标准和规范上传至数据库,òq¶å¯¹æ•°æ®çš„准¼‹®æ€§ã€?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性负责。医疗器械经营企业、医疗机构、政府相关部门及公众可通过数据查询、下载、数据对接等方式å…׃ín</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识数据ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 六、《规则》施行前已上市äñ”品是否需要赋äº?/span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识åQ?/span> </b><b><br /> </b><span style="font-size:14px;"> 《规则》实施之日è“våQŒæ³¨å†Œäh</span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案人应当在甌™¯·ç›¸å…³åŒÈ–—器械注册、注册变更或者办理备案时åQŒåœ¨æ³¨å†Œ</span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案½Ž¡ç†¾pȝ»Ÿä¸­æäº¤å…¶äº§å“æ ‡è¯†ã€‚相兛_Œ»ç–—器æ¢îCñ”品应当在生äñ”˜q‡ç¨‹ä¸­èµ‹äºˆåŒ»ç–—器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识åQŒåœ¨äº§å“ä¸Šå¸‚销售前应当完成åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识产品标识和相å…Ïx•°æ®çš„上传ã€?/span><br /> <span style="font-size:14px;"> 《规则》实施之日前已生产、销售的åŒÈ–—器械可不具备åŒÈ–—器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 七、如何选择åŒÈ–—器械</span></b><b><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span></b><b><span style="font-size:14px;">标识数据载体åQ?/span> </b><b><br /> </b><span style="font-size:14px;"> 当前市面上常用的数据载体包括一¾l´ç ã€äºŒ¾l´ç å’Œå°„频标½{¾ï¼ˆ</span><span style="font-size:14px;">RFID</span><span style="font-size:14px;">åQ‰ã€?/span><br /> <span style="font-size:14px;"> 一¾l´ç æ˜¯åªåœ¨ä¸€¾l´æ–¹å‘上表示信息的条码符åøP¼Œåº”用多年已经很成熟,成本低,能很好兼容市面上现有的扫码设备,但一唯码所占空间大åQŒç ´æŸçº é”™èƒ½åŠ›å·®ã€?/span><br /> <span style="font-size:14px;"> 二维码是在二¾l´æ–¹å‘上都表½CÞZ¿¡æ¯çš„条码½W¦å·åQŒç›¸æ¯”于一¾l´ç åQŒç›¸åŒç©ºé—´èƒ½å¤Ÿå®¹¾UÏx›´å¤šçš„数据åQŒåœ¨å™¨æ¢°åŒ…装ž®ºå¯¸å—限的时候能发挥很好的作用,具备一定的¾U é”™èƒ½åŠ›åQŒä½†å¯¹è¯†è¯»è®¾å¤‡çš„要求相较于一¾l´ç è¦é«˜ã€?/span><br /> <span style="font-size:14px;"> ž®„频标签å…ähœ‰ä¿¡æ¯å­˜å‚¨åŠŸèƒ½åQŒèƒ½æŽ¥æ”¶è¯Õd†™å™¨çš„ç”늣è°ƒåˆ¶ä¿¡å·åQŒåƈ˜q”回相应信号的数据蝲体。射频标½{„¡š„载体成本和识读设备成本相较于一¾l´ç å’ŒäºŒ¾l´ç è¦é«˜åQŒä½†</span><span style="font-size:14px;">RFID</span><span style="font-size:14px;">è¯Õd–速度快,可以实现扚w‡è¯Õd–åQŒåœ¨æŸäº›çŽ¯èŠ‚和领域能够发挥作用ã€?/span><br /> <span style="font-size:14px;"> 注册äº?/span><span style="font-size:14px;">/</span><span style="font-size:14px;">备案人可æ ÒŽ®äº§å“çš„特征、ä­h倹{€ä¸»è¦åº”用场景等因素选择适当的医疗器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识数据载体ã€?/span><br /> <span> </span><b><span style="font-size:14px;"> 八、发码机构需要具备什么样的资质,其职责和义务有哪些?</span></b><b><br /> </b><span style="font-size:14px;"> 器械</span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识的发码机构应当äؓ中国境内的法人机构,具备完善的管理制度和˜qè¡Œä½“ç³»åQŒç¡®ä¿æŒ‰ç…§å…¶æ ‡å‡†åˆ›å¾çš„医疗器æ¢?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">标识çš?/span><span style="font-size:14px;">å”?/span><span style="font-size:14px;">yi</span><span style="font-size:14px;">性,òq¶ç¬¦åˆæˆ‘国数据安全有兌™¦æ±‚ã€?/span><br /> <span style="font-size:14px;"> 发码机构应当向注册äh</span><span style="font-size:14px;">/</span><span 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