News & Events

Health Canada’s Pre-market Guidance for Machine Learning-enabled Medical Devices: What Manufacturers Need to Know

Health Canada’s Pre-market Guidance for Machine Learning-enabled Medical Devices1, published in February 2025, provides essential direction for manufacturers seeking approval for medical devices that incorporate machine learning (ML). As artificial...

Did you know that Canada’s New Substances Notification Regulations (NSNR) apply to NHPs and VHPs? 

Natural Health Products (NHPs) and Veterinary Health Products (VHPs) are regulated under the Food & Drugs Act, but that does not mean they’re exempt from environmental or new-substance rules. If...

Canada vs. Europe – Review of Medical Device Regulations 

The medical device industry is a cornerstone of global healthcare, and understanding regulatory requirements across jurisdictions is essential for manufacturers aiming to enter international markets. Among the key markets, Canada...

Change to Aluminum and Steel Tariffs could impact your products 

On August 18, 2025, the U.S. Department of Commerce expanded tariffs on steel and aluminum derivatives. They added 407 new product categories that are subject to a 50% tariff rate...

Change to Aluminum and Steel Tariffs could impact your products 

On August 18, 2025, the U.S. Department of Commerce expanded tariffs on steel and aluminum derivatives. They added 407 new product categories that are subject to a 50% tariff rate...

Proposed New Regulatory Framework for Consumer Chemical Products 

Proposal to Remove the Exemption In 2023, Health Canada published a notice of intent (NOI) to consult stakeholders on a proposal that has far-reaching implications for manufacturers, importers, and suppliers...

Understanding Sizing Requirements for Consumer Product Labeling in Canada 

When introducing a new consumer product to the Canadian market, it’s important to understand what the labeling requirements are, and how they affect your product(s). In addition to the Consumer...

Navigating the Regulatory Landscape: Selling Veterinary Health Products in Canada 

Veterinary Health Products (VHPs) in Canada play a vital role in promoting the wellbeing of both companion and food producing animals. VHPs in Canada are low-risk products that include vitamins,...

HMIRA Claims: Protecting Confidential Business Information in Canada 

If you sell chemical products in Canada, you may be required to disclose ingredient information on your Safety Data Sheet (SDS) as part of the HPR (Hazardous Products Regulation). But...

Understanding Canadian Food Labelling Regulations: A Guide to Country-of-Origin Food Labelling in Canada 

With more Canadian consumers prioritizing transparency and supporting local businesses, food brands are increasingly looking to highlight their Canadian roots. But under Canadian food labelling regulations, using the phrase “Canadian”...

Probiotics, Prebiotics, Postbiotics — Oh My! 

Postbiotics have gained significant attention in recent years, but despite growing interest in these ingredients, regulatory acceptance in Canada remains uncertain. In Canada, any product making a health claim must...

Canada and Switzerland Updates Mutual Recognition Agreement for Drug GMP Evidence 

Health Canada has recently published an update in the Drug Establishment Licensing Bulletin #187, highlighting significant expansions to the Canada–Switzerland Mutual Recognition Agreement (MRA). While the text of the MRA...

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