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 […]
Emergo Group
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 […]
10 questions companies affected by European MDR should be asking
By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations will impact their business. Based on feedback from clients as well as our own analysis of the MDR, […]
China FDA getting rid of medical device testing fees
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of 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 reflect those of DrugDeliveryBusiness.com […]
Common medical device QMS problems: difficult auditees
By Stewart Eisenhart, Emergo Group Part three of our blog series on common medical device quality system audit problems examines ways to deal with difficult auditees in order to successfully obtain information and evaluate processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
European Parliament approves new medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The European Parliament has officially voted to approve the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
MFDS launches new medical device recall system in South Korea
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has rolled out a new system for medical devices subject to recalls 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 […]