By Stewart Eisenhart, Emergo Group Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices regarding what to include in their Medical Device License (MDL) applications and commercialize in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]

By Stewart Eisenhart, Emergo Group Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements. Below, we’ve compiled several important Brazilian market and […]

By Stewart Eisenhart, Emergo Group The British government has asked for – and the EU Member States unanimously agreed to– a further extension of the article 50 procedure, by which a Member State can leave the EU in two years’ time. The previous date had been set at March 29th, then it was extended until […]

By Stewart Eisenhart, Emergo Group The Japanese Ministry of Health, Labour and Welfare (MHLW) is extending the country’s participation in the Medical Device Single Audit Program through early 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]

By Ronald Boumans, Emergo Group New guidance from European regulators addresses data entry timelines for the Eudamed medical device database, as well as how to develop and assign Unique Device Identification (UDI) data for “legacy devices.” Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]

By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]

By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]

By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions […]

By Mark Leimbeck, Emergo Group Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Get the full story here at […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year. Get the full story here at the Emergo Group’s blog. […]