By Stewart Eisenhart, Emergo Group
Medical device manufacturers thinking about market authorization pathways in Canada can learn more about the process via this Emergo podcast.
Emergo Managing Director for Canada Daryl Wisdahl explains key issues related to Canadian regulatory requirements for medical devices, including:
- Medical Device Licensing (MDL) and Medical Device Establishment Licensing (MDEL) requirements
- Canadian Medical Device Regulations (CMDR) and quality management system compliance
- Selling your medical device directly versus through distributors in Canada
Additional Emergo resources on Canadian medical device regulations include our video overview of Canada’s medical device market, our regulatory chart on the Canadian registration process, and our executive guide for conducting business in Canada.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.