Mishra Sundeep
Indian Heart J. 2017 Jan-Feb;69(1):1-5. doi: 10.1016/j.ihj.2016.11.327. Epub 2016 Dec 27.
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive.
医疗器械利益相关者之间正在进行一场激烈的辩论，讨论美国食品药品监督管理局（FDA）认证、CE认证或其他认证方式哪种更好。目前，获取FDA批准的过程因不可预测性不断增加、缺乏一致性、耗时过长和费用高昂而陷入困境，但CE认证也有其自身的问题。从历史上看，在三大主要认证体系中，日本的审核流程往往是最慢的，但最近随着加速审核流程的引入，已经取得了显著进展。虽然创新者/制造商的目标是开发、生产和销售能够满足未被满足的临床需求的医疗器械，但必要的监管审批流程可能会非常令人困惑。不仅监管事务专业人员会抛出大量术语，如“实质等同性”“日本药品和医疗器械管理局（PMDA）”“CE认证”“公告机构”“510K申请”和“上市前批准（PMA）”，而且实际的审批过程也可能非常缓慢、缺乏一致性且成本高昂。
