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 DrugDeliveryBusiness.com or […]
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Brazil ANVISA improves medical device registration review timeframes for 2018
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 […]
New program with payors aims to accelerate patient access to medical devices
Scott Gottlieb, M.D. Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval. We take many steps to make sure products can be safely accessed in the […]
China FDA loosens documentation requirements for renewals, clinical trial applications
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 […]
Egypt CAPA expands medical device oversight regulations
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 […]
Is your medical device affected by new EU regulations?
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 […]
FDA proposes Class I designation for some medical device accessories
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 […]
UK MHRA issues new guidance for medtech and IVD companies in wake of Brexit
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 […]
Saudi Arabia updates clearance policy for medical device shipments
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 […]
FDA increases medical device user fees in 2019
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 […]