By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Emergo Group
Indian CDSCO releases FAQ on medical device rules
By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA plans 2018 update for global UDI database
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers. 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 accessibility for medical device regulators outside of Europe
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 […]
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 […]
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 […]
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. […]