By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]
No management support is common QMS audit problem
By Stewart Eisenhart, Emergo Group Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that […]
Brazilian ANVISA denies half of high risk medical device registrations in 2016
By Stewart Eisenhart, Emergo Group Nearly half of some higher-risk registro registration applications to Brazilian medical device regulator ANVISA were rejected in 2016, according to the agency’s own performance report. 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 […]
South Korean regulators clarify UDI, KGMP rules for medical devices
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has issued clarifications on medical device registration and quality system requirements whose enforcement dates are imminent. 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 […]
Mexican drug registration renewals now apply to medical devices
By Stewart Eisenhart, Emergo Group Recent changes to modification and renewal requirements for drug registrations in Mexico may soon apply to medical devices, as well. 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 […]
MDSAP status update for Australian medical device companies
By Stewart Eisenhart, Emergo Group Now that the Medical Device Single Audit Program has moved past its pilot phase in participating medical device markets, how are manufacturers and regulators warming to the program? Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Medical device companies face biggest challenges with regulatory compliance
By Stewart Eisenhart, Emergo Group Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey. 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 […]
South African medical device companies have new licensing deadline
By Stewart Eisenhart, Emergo Group South Africa’s Medicines Control Council (MCC) has set a six-month deadline for domestic medical device and IVD manufacturers and distributors to apply for licensing in order to legally operate in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Russian deadline for replacing old medical device license extended
By Stewart Eisenhart, Emergo Group The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize requirements under the Eurasian Economic Union Agreement. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Medical device companies report sales increases in 2016
By Stewart Eisenhart, Emergo Group One third of all medical device companies participating in a recent Emergo industry survey reported sales increases of 10% or more for 2016. 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 […]
