health canada - SNI Inc.

18 Dec 2025

Health Canada Proposes Changes to Medical Device Establishment Licensing (MDEL): What Importers, Distributors, and Manufacturers Need to Know

Medical Deviceshealth canada, MDEL, MDEL amendments, Medical device distributors, Medical Device Establishment Licence, Medical device importers, medical device licensing Canada, Medical Devices Regulations

On November 8, 2025, Health Canada published proposed amendments to the medical device establishment licensing framework in the Canada Gazette, Part I. The consultation is open for stakeholder feedback until January 17, 2026. If you hold, or are planning to apply for, a Medical Device Establishment Licence (MDEL), these proposed changes…

04 Dec 2025

Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know

CosmeticsBasic Blue 7, Basic Violet 4, Cosmetic Ingredient Hotlist, cosmetic regulations Canada, cosmetic safety Canada, health canada, PHMB Canada, prohibited cosmetic ingredients, restricted cosmetic ingredients

Health Canada has begun a new consultation on proposed revisions to the Cosmetic Ingredient Hotlist, opening the door to significant changes in how cosmetic ingredients are reviewed, classified, and permitted for use in Canada. The consultation period runs from November 19th, 2025, to February 17th, 2026, marking a critical window for industry to…

02 Dec 2025

Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase

Foodbakery regulations, Canadian compliance, exo-inulinase, food additives, food enzymes, food industry Canada, GMP, health canada, Regulatory Updates, Trichoderma reesei

On November 20th, 2025, Health Canada released a new proposal signalling its intention to authorize exo-inulinase from Trichoderma reesei strain AR 577 as a permitted food enzyme in Canada. If the proposal moves forward, the change would be implemented through an update to the List of Permitted Food Enzymes following a public consultation period that closes on February 3rd, 2026. The List of…

18 Nov 2025

2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders

Site LicensingCAPA, GMP compliance, GUI-0158, health canada, Importer Requirements, natural health products, quality management system, Site Licence, Validation and Stability Testing

When Health Canada released Version 4.0 of the Good manufacturing practices guide for natural health products (GUI-0158) on September 4, 2025, it marked the first major revision of good manufacturing practices (GMP) expectations in a decade. The new guide, which will become enforceable on March 4, 2026, following a six-month…

30 Oct 2025

Understanding MDSAP and Its Role in Canadian Market Access

Medical DevicesFood and Drugs Act, health canada, ISO 13485, ISO 13485:2016, MDL Canada, MDSAP, MDSAP audit, MDSAP audit cycle, MDSAP audit process, MDSAP Canada, MDSAP certification, Medical Device Licence, Medical Device Single Audit Program, Medical Devices Regulations

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously. In Canada, MDSAP serves as the recognized mechanism…

28 Oct 2025

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare

Clinical TrialsClinical Research, Clinical Trial Oversight, Clinical trials, Critical to Quality, CRO, CtQ Factors, GCP, Good Clinical Practice, health canada, Health Canada guidelines, ICH E6(R3), Investigators, QMS, quality management system, Regulatory Compliance, Regulatory Update, Research Ethics Boards, Risk-Based Quality Management, Sponsors

On October 17th, Health Canada has confirmed it will implement the ICH E6(R3) Good Clinical Practice (GCP) guideline, a major international update to the way clinical trials are designed, managed, and documented. The goal is to strengthen participant safety, improve data quality, and modernize how clinical research is conducted in Canada. …

23 Oct 2025

Cosmetic Labelling in Canada: What You Need to Know

Cosmeticsbilingual labelling, Bill 96, CNF, consumer protection, Cosmetic Ingredients, cosmetic labelling, Cosmetic Packaging, cosmetic regulations, Cosmetic Safety, health canada, INCI, Label Design Canada, Regulatory Compliance

When introducing a new cosmetic product to the Canadian market, manufacturers and importers must meet several key regulatory obligations. Products must contain only safe ingredients that are permitted for cosmetic use, be properly notified to Health Canada through a Cosmetic Notification Form (CNF), and display labels that fully comply with…

25 Sep 2025

NHP Clinical Trials – Feasibility and Portfolio Assessment

Clinical TrialsCanadian regulation, clinical governance, GCP, health canada, natural health products, NHP clinical trials, NNHPD, portfolio assessment

Clinical trials for natural health products (NHPs) such as vitamins, herbal remedies, and probiotics bring scientific rigour to traditional health claims. In Canada, where consumer protection and evidence-based regulation are priorities, sponsors are beginning to shift away from running isolated trials toward building comprehensive clinical research strategies. This shift reflects…

23 Sep 2025

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…

18 Sep 2025

Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

NHPscanadian regulations, health canada, innovation, public health, Public Health Agency of Canada, red tape reduction, regulatory modernization, regulatory reform, risk-based regulation, trade barriers

Cutting red tape is at the heart of Health Canada and the Public Health Agency of Canada’s new regulatory modernization plan. In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…