Blog
Medical Device License (MDL) Renewals
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more
Jessica Koves
November 25, 2021
Blog
What You Need to Know – Software as a Medical Device (SaMD)
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
... Read more
Jessica Koves
October 28, 2021
News
US Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read more
Kalpna Mistry
October 11, 2021
News
Public Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
... Read more
Kalpna Mistry
September 14, 2021
Blog
MDSAP: What Is It and How Does It Apply to my Medical Device?
Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
... Read more
Trevor Rocheleau
August 20, 2021
News
Public Consultation on Medical Devices Clinical Trials Modernization Initiative
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
... Read more
Trevor Rocheleau
July 16, 2021
News
Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
... Read more
Marleen Haroon
July 2, 2021
News
Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
... Read more
Nawid Safi
June 15, 2021
Blog
Ensuring Predictability for Interim Orders Relating to COVID-19
Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
... Read more
Kalpna Mistry
December 15, 2020
Blog
Regulatory Considerations for Non-Medical Masks or Face Coverings
Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
... Read more
Kalpna Mistry
September 13, 2020
Blog
Illegal Marketing of Drugs and Medical Devices in Canada
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
... Read more
Quality Smart Solutions
January 20, 2020