By Stewart Eisenhart, Emergo Group Brazilian regulators are leaving in place the latest deadline of May 1, 2017 for new INMETRO certification requirements for some medical devices, despite extending this deadline twice in the past. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
blog
New Brazilian sanitary licensing regulations for medical device companies
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has implemented new risk-based requirements for domestic companies to obtain sanitary licenses. 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 its employees.
Working to raise awareness and reduce health disparities
By: Jonca Bull, M.D. April is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.” FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food […]
UK medical device regulators replacing OBL with ‘Virtual Manufacturing’
By Stewart Eisenhart, Emergo Group Recent guidance from the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK’s medical device market regulator, establishes the term “virtual manufacturing” to replace Own Brand Labeling (OBL) used by companies that place their names on devices made by other manufacturers. Get the full story here at the Emergo Group’s […]
Improving the safety of imported foods through partnerships
By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M. At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families. In passing the FDA Food Safety Modernization Act (FSMA), […]
Columbian regulators reduce medical device and IVD review timeframes
By Stewart Eisenhart, Emergo Group Medical device and in vitro diagnostic (IVD) market regulators in Colombia have pushed through changes to registration and modification processes with immediate effect. 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 […]
Malaysian combination product regulatory policy deadlines set
By Stewart Eisenhart, Emergo Group Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations marketed 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 and do not necessarily reflect […]
Brexit effects on Authorized Representatives in EU and UK
By Ronald Boumans, Emergo Group On 29 March 2017, the United Kingdom’s ambassador to the European Union delivered a formal letter invoking Article 50 of the Treaty of the EU to the President of the European Council. This means the UK will leave the European Union in two years at the latest. The date of […]
IMDRF wants to harmonize terminology for adverse event reporting
By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs. 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 […]
America’s Got Talent – regulatory science style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition. FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory […]