~ ~ ~
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: 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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香港医疗器械管制办公室向业界介绍认证评核架构 - China Medical Device Manufacturer
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Sat, January 20th, 2018

2006 秋季刊 » 行业新闻
香港医疗器械管制办公室向业界介绍认证评核架构

香港医疗器械管制办公室(MDCO; www.mdco.gov.hk)于8月10日就其建议评核架构召开简报会,向30多位出席者介绍该架构的要求,并接受发问。

与欧盟认证机构制度类似,认证评核机构(CAB)将要求制造商提供相关文件,对产品的安全与性能给予评估。虽然目前此项手续仍为自愿行为,但在未来,所有在香港上市的医疗器械均必须通过医疗器械行政管制体系的认证。该单位表示,将于2007年开始研拟相关的法律。

已在澳洲、加拿大、日本、美国和欧盟通过标准评估的医疗器械,可自动获得认证而无须接受香港CAB评估。CAB由MDCO授权监管。有关建议文件信息,请访问:www.mdco.gov.hk/sc_chi/mdacs/mdacs.html。

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