By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices. 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 MassDevice.com or its […]

By Stewart Eisenhart, Emergo Group The Malaysian Medical Device Authority (MDA) is adding a three-year transition period for compliance to new medical device labeling rules. 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 MassDevice.com or […]

By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has issued a performance report for the first half of 2018 showing small but consistent improvements in marketing application review times as well as higher volumes of applications submitted compared to mid-2017. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have amended requirements for documentation related to registration renewals as well as clinical trial applications to simplify compliance. 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 […]

By Stewart Eisenhart, Emergo Group Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]

By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Medical Device Regulation (MDR) is widely available in draft form, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices. Get the full story here at […]

By Stewart Eisenhart, Emergo Group US medical device regulators have published a list of medical device accessories for which they are proposing classification as Class I devices. 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 […]

By Ronald Boumans, Emergo Group In early August 2018 the UK Medicines & Healthcare products Regulatory Agency (MHRA) issues three new guidance documents for medical device, IVD and related healthcare sectors to prepare for ramifications of Brexit. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]

By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance of medical device shipments at Saudi ports of entry. 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 […]

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency’s 2019 fiscal year at a much slighter rate than for 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]

By Evangeline Loh, Emergo Group In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]