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The process of bringing contraceptive medical devices to the Canadian market involves navigating a clearly defined but often complex regulatory framework. Products such as intrauterine devices (IUDs), diaphragms, condoms, and contraceptive sponges are considered medical devices and are regulated by Health Canada under the Medical Devices Regulations. This overview outlines...

When your Canadian importer changes, it’s not just a back-end operational update, it also triggers a regulatory obligation to update your product labels. Canadian food labelling regulations are designed to maintain transparency, traceability, and accountability across the supply chain. While the Canadian Food Inspection Agency (CFIA) offers flexibility during transitional...

On June 27, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) will release eight new monographs and revise three existing ones. These updates are part of Health Canada’s continued efforts to maintain regulatory guidance that is accurate, up to date, and reflective of current evidence and product trends. ...

For food brands entering the Canadian market, success hinges on more than taste and presentation, it depends on regulatory compliance, especially when it comes to product labels. Whether you’re a startup launching your first SKU or a multinational expanding your line, your product label is one of the most scrutinized...

In today’s increasingly competitive and informed health and wellness marketplace, scientific validation is no longer optional - it is a critical component of building consumer trust, meeting regulatory requirements, and ensuring long-term product success. As consumers become more educated and discerning about the health products they use, they demand proof...

Veterinary Health Products (VHPs) are low-risk substances intended to maintain or promote animal health. In Canada, VHPs include vitamins, minerals, botanicals, and homeopathic preparations used for both companion and food-producing animals. As interest in natural health products grows, so too does the demand for a transparent regulatory framework. This article...

Introduced Expansion On June 9, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) officially expanded its Workload Management Approach to include Class II natural health product (NHP) applications. This update changes how certain submissions will be reviewed based on urgency and commercial readiness. Specifically, the NNHPD is now...

Quality assurance (QA) plays a central role in the safety and credibility of natural health products (NHPs) in Canada. Manufacturers are required to meet high standards set by Health Canada to ensure their products are safe, effective, and made with consistent quality before they reach the consumer.  Canada’s regulatory framework...

Expanding into the Canadian food and natural health product market presents a unique set of regulatory challenges. From bilingual packaging requirements to specific nutrition facts and allergen declarations, manufacturers often face barriers that can delay product launches and increase operational costs. One practical and cost-effective solution to this issue is...

In the Canadian natural health product (NHP) industry, Good Manufacturing Practices (GMP) are not only a regulatory requirement but also a fundamental part of ensuring consumer safety, product quality, and trust. At the heart of GMP compliance is the Quality Assurance Person for NHPs (QAP). This individual is critical in...

Health Canada has released a Notice to Stakeholders outlining proposed updates to the Cosmetic Ingredient Hotlist. This notice serves as a heads-up for cosmetics manufacturers, importers, and formulators to review upcoming regulatory considerations and begin preparing for potential product reformulations. Overview: What is the Cosmetic Ingredient Hotlist? The Cosmetic Ingredient...

Canada's front-of-package (FOP) labelling requirements are designed to help consumers make healthier food choices by requiring certain prepackaged foods high in saturated fat, sugars, or sodium to carry a nutrition symbol. However, not all products are treated the same under these regulations. Many foods are either fully exempt or conditionally...

When most people think about prescription drugs, they may not consider the regulatory framework that determines which medicines are available only by prescription. But in Canada, this distinction is critically important and tightly governed by Health Canada through its Prescription Drug List (PDL).  In a recent regulatory update published on...

Sunscreen is more than a summertime staple; it's a frontline defence against premature aging, sunburn, and skin cancer. As consumer awareness around sun protection continues to grow, so does the demand for innovative, high-quality sunscreen products. But behind every tube on a drugstore shelf lies a rigorous regulatory journey. In...

Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada.  The DIN is not just a tracking number; it’s...

Over the years, research has consistently highlighted just how important sunscreen is in a daily skincare routine. Some people were ahead of the curve, protecting their skin from harmful UV rays long before sunscreen became a non-negotiable part of everyone’s morning regimen. But what many don’t realize is that bringing...

As part of its continued digital modernization, Health Canada has reaffirmed the requirement that drug product submissions be filed electronically, using either the Electronic Common Technical Document (eCTD) format or the non-eCTD format. The appropriate format depends on the type of regulatory activity and the product category. Health Canada’s April...

If you're working with Natural Health Products (NHPs) in Canada, it's essential to stay ahead of Health Canada’s regulatory updates. As of April 25, 2025, five updated NHP monographs will be published, and they may impact product licences, labelling, and formulation strategies.  Whether you're submitting a new Product Licence Application...

Finished Product Specifications (FPS) are crucial documents that outline the minimum quality standards an Natural Health Product (NHP) must meet before it can be imported, sold, or distributed in Canada. These specifications are mandated under Health Canada's Natural Health Products Regulations (NHPR), and every NHP must strictly comply with the...

Distributing Natural Health Product (NHP) samples at tradeshows in Canada is subject to clear regulatory requirements designed to protect consumer safety, ensure accurate labelling, and uphold Health Canada’s standards.  From proper packaging and compliant promotional claims to valid licensing and record-keeping obligations, all participants are responsible for operating in accordance...