By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
Emergo Group
FDA plans fast-track development and marketing program for medical devices that treat opioid addiction
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
FDA takes cautious approach to new regulations for OEM and third-party device servicers
By Joel Domanowski, Emergo Group The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services. Get the full […]
Brazil Anvisa changes market pathway for low-risk medical devices
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations. 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 […]
FDA clarifies multiple-function medical device oversight policy
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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 […]
Eudamed completes actors module testing
By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Health Canada launching new unit for digital health technology licensing
By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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 […]
What Brexit withdrawal means for MDR implementation in the U.K.
By Ronald Boumans, Emergo Group Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still […]
HFES conference to host workshop on risk analysis for summative usability tests
By Kate Jablonski, Emergo Group A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
China CFDA proposes regulatory framework for 3D-printed medical devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]