Log in or register
Share on LinkedInShare on LinkedIn

ARTICLE · 02 AUGUST 2024

New Requirements In Canada Relating To Drug And Medical Device Recalls

Torys
Torys
Contributor
Torys

Torys

Torys LLP is an international business law firm that works with clients who expect the best advice...

View firm profile
Explore more from Torys

Amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) that come into force on December 17, 2024 will establish new reporting...

CanadaTechnology
Teresa Reguly
Teresa Reguly
Yolande Dufresne
Yolande Dufresne
Eileen McMahon
Eileen McMahon
Ronald Cheung
Ronald Cheung
Author LinkedIn connections

Amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) that come into force on December 17, 2024 will establish new reporting requirements and other obligations regarding drug and device recalls in Canada.

What you need to know

  • These amendments will introduce new reporting obligations for both voluntary (company-initiated) and mandatory recalls ordered by Health Canada for drugs and medical devices.
    • For voluntary drug and medical device recalls, manufacturers and importers are required to report the recall to Health Canada within 24 hours after making the decision to conduct a recall. However, to align with international standards, manufacturers and importers no longer need to report Type III voluntary medical device recalls to Health Canada.

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

Register for freeORLog in

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

View source

Related Articles

Legal Intelligence Newsletters: sign up for the latest legal and regulatory news on your chosen topics

Read more about

Related Comparative Guides

See more popular content from

Article

Canada’s 2026 AI Strategy: What Businesses Need To Know

Canada's National Artificial Intelligence Strategy marks a significant shift in federal AI policy, moving away from standalone legislation toward a comprehensive framework that emphasizes privacy reform, data sovereignty, and business adoption. The Strategy outlines six interconnected pillars designed to position Canada as a global AI leader while addressing regulatory gaps through existing legal frameworks and new policy tools.
CanadaTechnology
Aird & Berlis LLP
Aird & Berlis LLP
Article

Government Of Canada Makes Significant Changes To Energy Project Approvals Process

On September 3, the Government of Canada published amendments removing seven types of energy projects from the Physical Activities Regulations (the Project List) under the Impact Assessment Act (IAA). As a result, these types of projects will no longer be subject to the IAA but will continue to be regulated by the Canada Energy Regulator Act (CER Act) or applicable provincial environmental assessment regimes.
CanadaEnergy and Natural Resources
Torys
Torys
Article

Ontario Invites Expressions Of Interest For Licences Under The Geologic Carbon Storage Act

Ontario has launched its first call for expressions of interest in carbon capture and storage licences under the new Geologic Carbon Storage Act, targeting Crown-owned pore space beneath lakebeds surrounding the Ontario Peninsula. The detailed submission requirements reveal expectations that proponents have advanced well beyond initial planning stages, with the process serving as a critical test of Ontario's emerging CCS framework and its attractiveness to industry.
CanadaEnvironment
Torys
Torys
Article

New Flight Path: Canada Seeks Private Investment In Airports Through Long-term Concession Arrangements

Canada has announced plans to attract private investment through long-term concessions to operate its four largest airports: Toronto-Pearson, Vancouver International, Montréal-Trudeau, and Calgary International. The federal government will retain ownership of the underlying airport land and assets while seeking tens of billions of dollars in private capital to be reinvested in regional airports and local transport infrastructure. Key details regarding the scope of private operational involvement, award
CanadaGovernment, Public Sector
Torys
Torys
Article

AI For All: Health, Data, Innovation, And Capital

Canada's National Artificial Intelligence Strategy targets healthcare as a priority sector for AI investment, proposing $500 million in growth capital and dedicated resources to keep talent and innovation within Canadian borders. The federal government outlines specific healthcare missions, data infrastructure investments, and venture capital initiatives designed to transform Canada from an AI research leader into a commercialization powerhouse.
CanadaStrategy
Torys
Torys