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美国FDA计划采用ISO 13485作为医疗器械法规

发布时间: 2018-08-30 16:58:22   审校:睿智   浏览次数:

美国食品药品监督管理局(FDA)是负责制定医疗器械行业法规的政府机构,它宣布打算将ISO 13485作为其质量体系立法的基础。

ISO 13485医疗器械—质量管理体系—用于法规的要求,是医疗器械行业质量管理体系的国际标准,已于2016年发布,旨在以高效透明的方式与其他管理体系协同工作。该项标准现已进入第三版,得到了FDA的大力支持,与FDA推动全球医疗器械监管流程融合的目标相一致。

FDA宣布将采用ISO 13485来代替其现行的质量体系法规,这是该项标准获得全球认可的重要一步。

FDA采用国际标准的计划受到了ISO/TC 210的热烈欢迎。ISO/TC 210是医疗器械质量管理和通用要求标准化技术委员会,目前是由ISO的美国成员ANSI负责。

美国医疗器械促进协会(AAMI)的威尔·瓦格斯(Wil Vargas)担任ISO/TC的210秘书,他指出:“FDA的这一宣布将使全球医疗器械行业的法规要求协调到一个新的水平。”ISO/TC 210主席彼特·林德斯(Peter Linders)补充说:“考虑到ISO 13485作为医疗器械单一审核计划(MDSAP)的基础,FDA的这一大胆举措合乎逻辑。医疗器械单一审核程序(MDSAP)目前是由澳大利亚、巴西、加拿大、日本和美国运营。”

FDA plans to use ISO 13485 for medical devices regulation

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI.ISO’s member in the United States.

Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI), and Secretary of ISO/TC 210, said “this announcement will take global harmonization of regulatory requirements in the medical devices sector to a next level”. The committee Chair, Peter Linders, added that “this bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan and the USA”.

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