Top Regulatory Mistakes Companies Make (and How to Avoid Them)
Most regulatory failures don’t stem from a single bad decision. They develop quietly, over time, through small oversights that [...]
New Transition Regulations to address Interim Orders for Medical Devices
Due to the Covid-19 outbreak early this year, the Minister of Health took swift action in March through the [...]
Health Canada’s new child-resistant refillable vaping device and part container requirements
On November 19, 2020, Health Canada issued a letter to the Vaping Product Industry outlining Health Canada’s planned approach [...]
Modified Approach to Posting Medical Device Recalls Online
As part of Health Canada’s risk-based approach to ensure its transparency efforts are focused on Canada’s most important health [...]
Health Canada’s Final Guidance on Software as a Medical Device
On December 18, 2019 Health Canada published a guidance document on Software as a Medical Device (SaMD): Definition and [...]