On 7 January 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations.
The notice of consultation:
- advised of the notice of intent published on 11 December 2021; and
- requested feedback on a cost-benefit analysis survey.
The proposed amendments would:
- streamline medical device establishment licence (MDEL) holders' application requirements to reflect existing practices;
- provide the Minister of Health with new and expanded authorities over MDELs, including the ability to issue terms and conditions on a MDEL and partially suspend or cancel a MDEL to mitigate risks to health and safety; and
- implement ministerial authority to order recalls of medical devices, harmonise the definition of "recall" and clarify industry reporting obligations in guidance.
The notice of intent remained open for comment until 11 February 2022.
For further information on this topic please contact Katie Lee at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.