昂思微迪—新秀联手听力老牌一块打造助听新标杆
<a style="color: black;"><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/qfHfmEUr8fxObMMNI0LC5e91fWzIKu8pD3aNuzWMzCibqZulvBTLriaQKXKPKQCRN6lDQibutdCD5Bsic1iag4I2CfA/640?wx_fmt=jpeg&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></span></a><span style="color: black;"><p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">随着美国FDA发布OTC助听器类目规范草案，消费类助听、辅听耳机市场被点燃，相继有不少厂商入局，从市场行情来看，传统助器器价格非常昂贵，高端市场<span style="color: black;">始终</span>被五大国际集团牢牢把持，<span style="color: black;">她们</span>都是<span style="color: black;">持有</span>几十年<span style="color: black;">乃至</span>上百年的技术和市场沉淀，占据了<span style="color: black;">全部</span>助听市场份额的90%以上，这得益于<span style="color: black;">她们</span>的<span style="color: black;">途径</span>完善，技术壁垒和医疗资质的健全。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">昂思科技在三年前<span style="color: black;">起始</span>布局助听器的算法和芯片的<span style="color: black;">开发</span>，已深度与清华大学、南京大学、桂林电子科技大学，301医院等高校教授和学者合作，<span style="color: black;">日前</span>已<span style="color: black;">持有</span>一批算法专利及广泛的用户数据。2022年，昂思科技与四川微迪联手成立思迪听力，<span style="color: black;">将来</span><span style="color: black;">咱们</span><span style="color: black;">一块</span>深入声学听力方面的<span style="color: black;">科研</span>，并<span style="color: black;">连续</span>聚焦医疗，耳科<span style="color: black;">关联</span>医疗<span style="color: black;">器具</span>。</p>
</span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/qfHfmEUr8fzsNZ3pQe0UcgNlzY67GXmoia31lQqIQfwpVElwWYSe9kgvGdgiapYuupdrbbKDDMvIbmAqRJSWxHAA/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">四川微迪数字技术有限<span style="color: black;">机构</span>（Micro-DSP Technology Co., Ltd）<span style="color: black;">是由于</span>加拿大著名听力学家Dr. Robert McRae于1999年在成都创建的有限责任<span style="color: black;">机构</span>，<span style="color: black;">日前</span>在美国、加拿大、北京、武汉等地设有分<span style="color: black;">机构</span>和零售网络。<span style="color: black;">机构</span>致力于从事<span style="color: black;">开发</span>、生产、<span style="color: black;">营销</span><span style="color: black;">拥有</span>自主知识产权的，将数字信号处理技术应用在现代医学<span style="color: black;">行业</span>的诊断、治疗和改善<span style="color: black;">公众</span>传播失调<span style="color: black;">疾患</span>的医疗器械和设备。<span style="color: black;">重点</span><span style="color: black;">制品</span>和技术涵盖全数字语音技术、数字医疗诊断仪器、助听器、言语<span style="color: black;">纠正</span>器、微型噪音消除器、语音PDA等任何对体积和耗电量有严格<span style="color: black;">需求</span>的<span style="color: black;">制品</span>。微迪数字<span style="color: black;">开发</span>，生产的<span style="color: black;">重点</span><span style="color: black;">制品</span>均属中国医疗器械二类<span style="color: black;">制品</span>，在美国，加拿大，欧洲等地属于一类或二类医疗器械。微迪数字<span style="color: black;">经过</span>了ISO 13485,加拿大CMDCAS认证，欧盟CE认证等质量和安全标准。除助听器外，在耳鸣诊断，口吃校正等方面的<span style="color: black;">制品</span>和<span style="color: black;">科研</span>，都是国内的首创者和市场领导者。</span></span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/qfHfmEUr8fzzNfYniaGxStxHz0ibvylmx1ItXRVT7EkHtEld1FPY9yO7qQmKWCLibJAeaZ71UpUo0pJicfrjfIZo8w/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">日前</span>的医疗资质分为械字号注册（中国）、FDA 认证（美国），CE&ISO 13485 (欧洲)，JGMP (日本)。<span style="color: black;">此刻</span>国内大部分企业申请都是美国FDA一类（不带蓝牙）并且<span style="color: black;">无</span>械字号,FDA二类的注册更加<span style="color: black;">繁杂</span>，并且对企业的资质<span style="color: black;">需求</span>更高。关于FDA二类的注册<span style="color: black;">详细</span>流程和<span style="color: black;">重视</span>事项，<span style="color: black;">咱们</span>做了如下的汇总：</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">一．注册内容：</p>
</span></strong></span><span style="color: black;">1.带蓝牙功能的助听器</span><span style="color: black;">2.二类<span style="color: black;">制品</span>代码：QSM</span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3.FDA<span style="color: black;">制品</span>列名注册+邓白氏码注册+UDI码注册</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">二．UDI条形码法规<span style="color: black;">重视</span>事项：</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.MDL/LST: Medical Device Listing Number<span style="color: black;">制品</span>注册号码</p>
</span></strong></span><span style="color: black;">GMP: 供应商需要符合美国医疗器械质量管理体系法规 CFR21 QSR820</span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">UDI: 需要加贴符合美国医疗器械UDI条形码法规的条形码</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.<span style="color: black;">重视</span>事项：</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）FDA UDI 条形码法规：所有出口美国医疗器械(除UDI规定的豁免<span style="color: black;">制品</span>)的包装必须参见下列强制执行日期加贴符合FDA UDI法规<span style="color: black;">需求</span>的条码；和<span style="color: black;">即时</span>报送UDI<span style="color: black;">关联</span>数据到FDA UDI数据库供公众<span style="color: black;">查找</span>；<span style="color: black;">详细</span>强制执行日期如下：</p>
</span><span style="color: black;">大部分Class III类医疗器械<span style="color: black;">制品</span>，从2015年10月24日<span style="color: black;">起始</span>强制执行；(中国出口较少)</span><span style="color: black;">大部分Class II 类医疗器械<span style="color: black;">制品</span>，从2016年09月24日<span style="color: black;">起始</span>强制执行；(中国出口较多)</span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">大部分Class I 类医疗器械<span style="color: black;">制品</span>，从2022年09月24日<span style="color: black;">起始</span>强制执行； (中国出口最多)</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（2）请<span style="color: black;">重视</span>， FDA禁止在医疗器械<span style="color: black;">制品</span>，或包装上打印FDA标志， 或描述为FDA<span style="color: black;">准许</span>，<span style="color: black;">经过</span>FDA审核等字样，都属于违反了FD&C Act的301（L）款。任何和这些符号<span style="color: black;">关联</span>的给人<span style="color: black;">导致</span>FDA官方认可印象的<span style="color: black;">描述</span>都属于标签误用。</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国内医疗器械注册是一个繁杂而漫长的过程，不仅需要企业本身具备<span style="color: black;">浑厚</span>的实力和专业的素质，<span style="color: black;">况且</span>对<span style="color: black;">全部</span>过程要有丰富的经验。<span style="color: black;">首要</span>，工厂的生产和管理必须健全，GMP质量体系针对助听器二类医疗器械的认证，<span style="color: black;">触及</span>到电子，电声，生物医疗，电子电磁，运输鉴定等一系列的标准，管理者必须对这些有足够的理解；其次，对助听器的规格编写，测试设备的参数标准，以及现场验厂的审核和流程都要有丰富的经验。在时间的规划和安排上，工厂搭建GMP体系大概需要1~2个月，技术手册编写1~2个月，<span style="color: black;">制品</span>测试4~5个月，注册审核6个多月，最后政府<span style="color: black;">分部</span>现场审核，在审核<span style="color: black;">经过</span>的前提下，还需要2-3个月<span style="color: black;">才可</span>拿到医疗许可证，<span style="color: black;">因此</span><span style="color: black;">一般</span><span style="color: black;">来讲</span><span style="color: black;">全部</span>注册认证的周期---从<span style="color: black;">制品</span>设计到医疗器械号注册完成---需要18~20个月的周期。<span style="color: black;">因此</span><span style="color: black;">仅有</span>定位清晰，计划深耕这个赛道的企业才会预留<span style="color: black;">海量</span>人力精力财力去完成<span style="color: black;">全部</span>流程。</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/qfHfmEUr8fzsNZ3pQe0UcgNlzY67GXmooZ6pfjUwAskq22bYMuLTJiciayNZicNvBmXPcUDymYXd8UJyas37xal6w/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">日前</span>昂思已有一批过硬的技术人员专注在助听<span style="color: black;">制品</span>的<span style="color: black;">开发</span>上，从结构，电子，声学，芯片和算法，每一个环节都有专业的技术团队在把控，<span style="color: black;">咱们</span>的专业和专注使<span style="color: black;">咱们</span>的<span style="color: black;">制品</span>在外观和品质上都受到消费者的<span style="color: black;">喜欢</span>，初代<span style="color: black;">制品</span><span style="color: black;">已然</span>在北美畅销。</p>
</span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/qfHfmEUr8fzsNZ3pQe0UcgNlzY67GXmoVTjEnvZb4MjeoggSicloGJKM7eJXxuaBA7aW4oxrWYvTQFGQYzXjiaew/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/qfHfmEUr8fzsNZ3pQe0UcgNlzY67GXmoDNXsCfHEH8VhUz661ZZRRRu7Kg3ia6DyQWInBCyHicLHEWh9YXoWAhTw/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">昂思科技定南工厂<span style="color: black;">持有</span>独栋厂房和现代化的测试和生产设备，总计面积12000平方米，<span style="color: black;">机构</span><span style="color: black;">经过</span>ISO 9001质量管理体系和BSCI认证，有的<span style="color: black;">制品</span><span style="color: black;">得到</span>迪士尼管理体系认证，<span style="color: black;">日前</span>同多个品牌有合作，<span style="color: black;">例如</span>诺基亚，酷狗等。经<span style="color: black;">太多</span>年用心经营，在音频和助听<span style="color: black;">行业</span>，摸索出了一条自主创新的发展道路，形<span style="color: black;">成为了</span>独特的核心价值。<span style="color: black;">机构</span><span style="color: black;">针对</span><span style="color: black;">每一个</span><span style="color: black;">制品</span>都采用高<span style="color: black;">需求</span>，高标准。<span style="color: black;">咱们</span>很荣幸与经销商和品牌商<span style="color: black;">创立</span><span style="color: black;">长时间</span>合作关系，为<span style="color: black;">她们</span><span style="color: black;">供给</span>定制服务。欢迎新老客户来<span style="color: black;">机构</span>参观，恰谈合作。</p>
</span><img src="data:image/svg+xml,%3C%3Fxml version=1.0 encoding=UTF-8%3F%3E%3Csvg width=1px height=1px viewBox=0 0 1 1 version=1.1 xmlns=http://www.w3.org/2000/svg xmlns:xlink=http://www.w3.org/1999/xlink%3E%3Ctitle%3E%3C/title%3E%3Cg stroke=none stroke-width=1 fill=none fill-rule=evenodd fill-opacity=0%3E%3Cg transform=translate(-249.000000, -126.000000) fill=%23FFFFFF%3E%3Crect x=249 y=126 width=1 height=1%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E" style="width: 50%; margin-bottom: 20px;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">昂思科技将参加<span style="color: black;">这次</span></span><a style="color: black;"><span style="color: black;">【2022（</span></a>夏季）亚洲智能穿戴展】</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">，展位号为：C83。欢迎行业伙伴前来大会现场与指南测控更进一步交流分享市场<span style="color: black;">新闻</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">联系人：谈小姐 13714462124 邮箱：yuby@music-labs.com联系人：詹先生 15099906639 邮箱：james@music-labs.com</p><a style="color: black;"><span style="color: black;">【2022（夏季）亚洲智能穿</span></a>戴展】<span style="color: black;">是我爱音频网为了促进智能穿戴、蓝牙音频市场快速发展，<span style="color: black;">帮忙</span>音频厂商快速找到<span style="color: black;">优秀</span>供应链、芯片、电池、技术、测试设备资源，<span style="color: black;">得到</span>市场的认可，而举办的一场行业峰会活动，届时将有200多家音频企业<span style="color: black;">这里</span>次展会带来最新的行业技术，并且有来自蓝牙音频行业知名企业的15位重磅嘉宾进行演讲干货分享，是一场音频人不可<span style="color: black;">错失</span>的<span style="color: black;">认识</span>智能穿戴、蓝牙音频<span style="color: black;">行业</span>最新<span style="color: black;">新闻</span>的行业大会。</span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">参展联系：info@52audio.com</p>
</span><span style="color: black;">【峰会报名】</span><span style="color: black;">2022（夏季）亚洲智能穿戴展</span><span style="color: black;">峰会开启报名</span><span style="color: black;"><a style="color: black;">2022(夏季）亚洲蓝牙耳机大会</a></span><a style="color: black;">2022（夏季）亚洲智能穿戴大会</a><span style="color: black;"><a style="color: black;">2022（夏季）亚洲助听辅听产业大会</a></span><a style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">广东智能声学行业协会-筹备大会</p>
</a><img src="data:image/svg+xml,%3C%3Fxml version=1.0 encoding=UTF-8%3F%3E%3Csvg width=1px height=1px viewBox=0 0 1 1 version=1.1 xmlns=http://www.w3.org/2000/svg xmlns:xlink=http://www.w3.org/1999/xlink%3E%3Ctitle%3E%3C/title%3E%3Cg stroke=none stroke-width=1 fill=none fill-rule=evenodd fill-opacity=0%3E%3Cg transform=translate(-249.000000, -126.000000) fill=%23FFFFFF%3E%3Crect x=249 y=126 width=1 height=1%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E" style="width: 50%; margin-bottom: 20px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">音频行业年度报告<span style="color: black;">连续</span>更新中，<span style="color: black;">倘若</span>你想<span style="color: black;">认识</span>消费类音频行业最新动态，欢迎关注</span></strong></span><strong style="color: blue;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">我爱音频网</span></strong></span></strong><span style="color: black;"><strong style="color: blue;"><span style="color: black;">呀：D</span></strong></span><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">优秀</span>音频供应商<span style="color: black;">能够</span>点击</span><span style="color: black;">蓝字</span><span style="color: black;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">认识</span></p>
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这夸赞甜到心里，让我感觉温暖无比。 这篇文章真的让我受益匪浅，外链发布感谢分享！
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