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Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: mktime() [function.mktime]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 61

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 62

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<p>国家食品药品监督管理局公布96项医疗器械行业标准</p> - China Medical Device Manufacturer
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Sat, January 20th, 2018

2011年2月CMDM电子快讯 » 行业新闻

国家食品药品监督管理局公布96项医疗器械行业标准

2010年12月27日, 中国国家食品药品监督管理局(SFDA)在网站公布了将影响中国医疗器械行业的96项新标准,其中包括34项强制性行业标准(标注为YY)和62项目推荐性行业标准(标注为YY/T)。96项标准将与2012年6月1日生效,它们是中国自2010年开始修订医疗行业标准以来,首批公布的新标准。

一些强制性标准取代了旧标准。比如YY 0054-2010《血液透析器械》将取代YY0054-2003, YY 0333-2010《软组织扩张器》将取代YY0333-2002。但是,许多标准是新标准,比如YY0804-2010《药液转移器》等。 推荐性行业标准涉及无菌医疗器械包装测试方法、牙齿根管设备、骨科移植设备等多个领域。

所有这些标准涉及超过90种应用广泛的产品,比如一次性医疗设备、移植和介入性医疗材料、高附加值医疗设备等。去年曾引起争议的血糖仪则不在新公布的强制性标准之内。

行业标准曾被视为中国医疗器械行业发展的瓶颈所在。 中国已经设立了特定行业领域的医疗器械行业标准。但是, 医疗器械标准的更新速度依旧非常缓慢。这不仅抑制了国内企业的创新热情,也增加了发生不良事故的风险。

新标准的公布受到医疗器械企业的广泛欢迎。人们期待新标准的出台有助于行业的标准化,并可提升中国医疗器械行业的整体水平。它也将促进将中国的行业标准与国际标准接轨。不过,医疗器械行业标准的更新速度依然有待提高。


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