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Regulatory approaches to stimulate innovative renal replacement therapies.
Nature Reviews Nephrology ( IF 41.5 ) Pub Date : 2020-04-02 , DOI: 10.1038/s41581-020-0275-8
Fokko P Wieringa 1, 2, 3 , Murray I Sheldon 4 , Ana Hidalgo-Simon 5
Affiliation  

Regulations for market access and reimbursement of medical devices vary across jurisdictions, complicating the development of innovative technologies for world-wide use; however, several converging regulatory principles are now emerging. Here we discuss approaches by which regulatory and related agencies can promote innovation and boost the effectiveness of regulatory processes to expedite patient access to innovative technologies, including renal replacement therapies.

中文翻译:

刺激创新性肾脏替代疗法的监管方法。

不同司法管辖区的市场准入和医疗设备报销法规不尽相同,这使得创新技术在全球范围内的应用变得复杂;但是,现在出现了一些融合的监管原则。在这里,我们讨论了监管机构和相关机构可以促进创新并提高监管程序有效性的方法,以加快患者获得包括肾脏替代疗法在内的创新技术的机会。
更新日期:2020-04-02
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