美國(guó)食品藥品監(jiān)督管理局（FDA）是負(fù)責(zé)制定醫(yī)療器械行業(yè)法規(guī)的政府機(jī)構(gòu)，它宣布打算將ISO 13485作為其質(zhì)量體系立法的基礎(chǔ)。

ISO 13485醫(yī)療器械—質(zhì)量管理體系—用于法規(guī)的要求，是醫(yī)療器械行業(yè)質(zhì)量管理體系的國(guó)際標(biāo)準(zhǔn)，已于2016年發(fā)布，旨在以高效透明的方式與其他管理體系協(xié)同工作。該項(xiàng)標(biāo)準(zhǔn)現(xiàn)已進(jìn)入第三版，得到了FDA的大力支持，與FDA推動(dòng)全球醫(yī)療器械監(jiān)管流程融合的目標(biāo)相一致。

FDA宣布將采用ISO 13485來(lái)代替其現(xiàn)行的質(zhì)量體系法規(guī)，這是該項(xiàng)標(biāo)準(zhǔn)獲得全球認(rèn)可的重要一步。

FDA采用國(guó)際標(biāo)準(zhǔn)的計(jì)劃受到了ISO/TC 210的熱烈歡迎。ISO/TC 210是醫(yī)療器械質(zhì)量管理和通用要求標(biāo)準(zhǔn)化技術(shù)委員會(huì)，目前是由ISO的美國(guó)成員ANSI負(fù)責(zé)。

美國(guó)醫(yī)療器械促進(jìn)協(xié)會(huì)(AAMI)的威爾·瓦格斯（Wil Vargas）擔(dān)任ISO/TC的210秘書，他指出：“FDA的這一宣布將使全球醫(yī)療器械行業(yè)的法規(guī)要求協(xié)調(diào)到一個(gè)新的水平。”ISO/TC 210主席彼特·林德斯（Peter Linders）補(bǔ)充說(shuō)：“考慮到ISO 13485作為醫(yī)療器械單一審核計(jì)劃（MDSAP）的基礎(chǔ)，F(xiàn)DA的這一大膽舉措合乎邏輯。醫(yī)療器械單一審核程序（MDSAP）目前是由澳大利亞、巴西、加拿大、日本和美國(guó)運(yùn)營(yíng)。”

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”.