ARQonApr 7, 20171 minUS FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book...
ARQonApr 7, 20171 minImpact of recent changes to Japan’s medical device regulations: a Competent Authority perspective - Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,...
ARQonApr 6, 20171 minAsia, Africa & Middle East - April 2017Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...
ARQonApr 5, 20171 minEurope - April 2017Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...