Regulatory Affairs

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 [...]

The medical device industry is a cornerstone of global healthcare, and understanding regulatory requirements across jurisdictions is essential for manufacturers aiming to enter international [...]

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 on their metal [...]

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, [...]

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 [...]

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, [...]

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 what if [...]

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 [...]

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 [...]

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). [...]