By Ronald Boumans, Emergo Group The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
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Brazil regulators extend Class III and IV medical device, IVD registration validity timeframes
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has extended the validity of higher-risk device and IVD registrations from five to 10 years, a major and auspicious change for manufacturers selling in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
EU gives Brexit notice to economic operators and impact for medical device industry
By Ronald Boumans and Annette van Raamsdonk, Emergo Group A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorized Representatives and Notified Bodies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Eudamed development on schedule
By Ronald Boumans, Emergo Group European regulators appear on track to launch the Eudamed database for medical devices in March 2020, but stakeholder accessibility may take longer than that. 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 […]
Charting the FDA’s course for 2018-2020
By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition […]
FDA delays contentious medical device intended use rule
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
FDA announces deadline for UDI compliance for low-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical 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 […]
FDA to expedite release of recall information
By: Douglas Stearn, J.D. When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant […]
Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants
By Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. […]
Medical Device Excise Tax set to return early this year
By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]