计划允许医疗器械制造商在一次审核中满足多国法规的质量管理体系要求。

加利福尼亚州,费利蒙,2017年8月14日 – 享誉全球的安全科学领导者UL今日宣布,已成功完成评估,并获得医疗器械单一审核程序(MDSAP)监管当局确认,成为被监管当局认可的审核机构(AO)。MDSAP的执行基于国际医疗器械监管者论坛(IMDRF)的程序文件。MDSAP成员机构包括美国(FDA)、澳大利亚(TGA)、巴西(ANVISA)、加拿大HC、以及日本(MHLW)。

MDSAP允许获认可的审核机构代表监管当局联盟(包括美国、加拿大、日本、巴西和澳大利亚)独立执行MDSAP审核。采用单一审核法能减少重复质量管理审核,有助于器械制造商更好地管理成本、放宽市场准入。

“MDSAP有助于简化监管批准流程,大大地减轻了制造商的负担,无需再承受来自多个监管机构的多次审核,”UL健康科学部法规服务经理Michael Windler表示。”我们有一支拥有平均在医疗器械和标准审核领域工作长达9年丰富审核经验的团队,这意味着他们无需花太多时间即可熟知创新型的医疗产品以及复杂的法规条款之间的各种细微差别和变化。”

对于计划加拿大上市销售的设备制造商而言,MDSAP已然是一个强有力的监管推动因素。程序将于2019年1月1日起取代当前的加拿大医疗器械合格评定体系(CMDCAS)程序。在过渡期间,加拿大卫生部同时认可依据MDSAP和CMDCAS颁布的证书。

之后,健康科学部将会推出关于MDSAP的网上研讨会,敬请期待。

欲知更多UL法规认证服务的更多信息,请通过如下方式联系我们,

华北地区:
Yumiko Qi 戚小姐
T: +86-21-61376331
E: Yumiko.Qi@ul.com

华南地区:
Ella Wang 汪小姐
T: +86-20-32131071
E: Ella.Wang@ul.com

关于UL

医疗产品全球上市的一站式服务专家。UL 拥有一支超过多年医疗行业经验的专家团队,为中国的广大有源和无源医疗制造厂商提供专业、有效的检验,测试,验证服务。协助客户满足复杂的法规监管要求,将其研发的创新产品更快,更顺利地推向全球市场。

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