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 […]
10 companies with interesting technology at BIOMEDevice Boston
BIOMEDevice Boston is an opportunity for over 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect. It is an industry showcase created by UBM in partnership with Massachusetts Medical Device Industry Council (MassMEDIC). The event – running May 3–4 at the Boston Convention and Exhibition Center – features […]
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 […]
Medtech stories we missed this week: April 28, 2017
From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates […]
12 interesting wearables you should know
Wearable technology is probably one of those things you probably didn’t need but still wanted because people were always talking about the devices. Fitbit, Apple and Garmin are some of the main providers of health and wellness wearables. Each of them touts being able to track your fitness activity or measures your heart rate. However, consumer […]
How medtech companies can benefit from agile marketing
Getting a medical device to market can be tough. It has to go through several hoops at the FDA, including the 5-step premarket requirements that include: classifying the device; choosing the correct premarket submission; preparing appropriate information for premarket FDA submission; sending a premarket submission to the FDA and communicating with FDA staff during review; and […]
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 […]