Health Canada Updates Compliance and Enforcement Policy for Health Products

Health Canada has published an updated version of POL-0001 — Compliance and Enforcement Policy for Health Products.

The September 2026 policy replaces version 9 and was implemented on 15 September 2026. It describes Health Canada’s national compliance and enforcement approach for health products regulated under the Food and Drugs Actand its regulations.

Scope of the Policy

The policy applies to Health Canada compliance and enforcement activities involving regulated health products and activities.

The products covered include:

• biocides;

• blood and blood components;

• cells, tissues and organs for transplantation;

• human drugs;

• medical devices;

• natural health products;

• veterinary drugs and veterinary health products.

Regulated activities include advertising, selling, manufacturing or fabricating, packaging and labelling, testing, importing, distributing, wholesaling and conducting clinical trials.

Regulatory Context

Health Canada explains that the current regulatory environment is shaped by complex global supply chains, rapid innovation, changing consumer behaviour and increasing domestic and international e-commerce.

The policy highlights risks associated with unauthorized or non-compliant health products, misleading information, labelling and advertising failures, contaminated or substandard ingredients and failures to meet manufacturing quality and safety requirements.

The Regulatory Operations and Enforcement Branch, or ROEB, is the branch responsible for Health Canada’s national compliance and enforcement programme.

Health Canada’s Role

Health Canada states that public safety is its highest priority when balancing the benefits and risks of health products.

ROEB carries out activities including:

• compliance promotion;

• inspections;

• laboratory analysis and testing;

• monitoring and verification activities.

Inspections remain a key tool for verifying compliance with the Food and Drugs Act and its regulations.

Inspector Powers

The policy explains that inspectors may enter regulated premises, including remotely in certain circumstances, and exercise powers permitted under section 23 of the Food and Drugs Act.

During an inspection, inspectors may:

• examine articles;

• collect samples;

• open packages;

• make copies and recordings;

• take photographs;

• reproduce electronic data;

• use computer and telecommunications systems;

• remove items for examination or testing;

• seize and detain articles.

This is particularly relevant for organisations maintaining electronic QMS records, digital technical documentation and remote business operations.

Responsibilities of Regulated Parties

The policy states that the primary responsibility of regulated parties is to understand and comply with applicable requirements.

Any party conducting regulated activities in Canada may be inspected, and foreign parties involved with products sold, imported or advertised in Canada are also subject to Canadian law.

Regulated parties are expected to ensure that their products, activities and processes comply with applicable legislation and to provide inspectors with reasonable assistance.

Failure to provide information, obstructing an inspector or knowingly providing false or misleading information may constitute an offence.

Healthcare Professionals and Facilities

Healthcare professionals and healthcare facilities may also have obligations under the Food and Drugs Act and its regulations where they conduct regulated activities.

Health Canada expects them to ensure that health products they buy or use are authorized for sale in Canada and obtained through an appropriate licensed, registered or authorized source.

Healthcare professionals are also expected to report suspected problems involving health products, including adverse reactions, malfunctions and possible non-compliance.

Medical Device Authorization

The policy clarifies that Class II, III and IV medical devices authorized for sale in Canada have a Medical Device Licence.

Class I medical devices do not require a Medical Device Licence and are instead monitored through Establishment Licensing.

Health Canada also points consumers and stakeholders toward the Medical Devices Active Licence Listing to verify authorized Class II to IV devices.

Guiding Principles

Health Canada identifies five main principles guiding compliance and enforcement activities:

• evidence-based decision-making;

• outcomes-focused action;

• risk-based oversight;

• fairness, consistency and impartiality;

• transparency.

Where evidence is incomplete or inconclusive, Health Canada may take a precautionary approach.

Risk-Based Enforcement

When assessing risk, Health Canada may consider factors such as:

• product safety and efficacy profile or risk classification;

• route of administration;

• intended population;

• seriousness of deviations from regulatory requirements;

• consumer exposure;

• potential harm from shortages;

• previous compliance history;

• likelihood of repeat non-compliance;

• cooperation and responsiveness of the regulated party.

This means enforcement action is not based only on the existence of a non-compliance, but also on its actual or potential impact on public health.

Compliance Promotion, Monitoring and Enforcement

The policy divides Health Canada’s compliance and enforcement tools into three broad categories:

1. Compliance promotion

2. Compliance monitoring

3. Enforcement

Compliance promotion includes policies, guidance and educational activities.

Compliance monitoring includes inspections, product sampling, laboratory analysis, review of labels and advertisements, complaints, recalls, shortages, medical device incident reports, adverse reaction reports and information received from foreign regulators.

Enforcement Actions

Where requirements are not met, Health Canada may take enforcement action proportionate to the risk.

Possible responses include:

• public advisories;

• changes to licence or authorization conditions;

• requests for corrective and preventive action plans;

• stop-sale requests;

• recalls;

• border detention or refusal;

• removal of prohibited advertising;

• orders to provide documents, information or samples;

• orders to conduct product assessments;

• licence or authorization suspension, cancellation or revocation;

• seizure and detention;

• court injunctions.

The policy also notes that regulatory responses may escalate if non-compliance persists.

Investigations and Prosecution

Health Canada may investigate suspected offences and may refer cases to the Public Prosecution Service of Canada.

Priority may be given to cases involving repeated non-compliance, intentional avoidance of legal requirements, unlicensed activities, sale of unauthorized products or conduct that could cause serious harm.

Depending on the offence, penalties under the Food and Drugs Act may include significant fines, imprisonment or both.

For offences involving therapeutic products under section 31.2, penalties can reach CAD 5 million on indictment, together with potential imprisonment.

What Changed in Version 10

The revision history states that version 10 was updated to:

• align with a newer document management template and Canada.ca style guidance;

• update the scope of products and activities covered;

• reflect ROEB’s current operating environment and emerging health and safety risks;

• clarify roles and responsibilities;

• strengthen alignment with Health Canada’s Compliance and Enforcement Policy Framework;

• improve legal precision regarding authorities.

Impact on Medical Device Manufacturers and Importers

For medical device manufacturers, importers, distributors, licence holders and regulatory teams, the updated policy reinforces Health Canada’s expectations around proactive compliance.

Stakeholders should pay particular attention to:

• product and establishment licensing;

• inspection readiness;

• electronic records and remote inspections;

• advertising and labelling compliance;

• import and distribution controls;

• incident and complaint reporting;

• CAPA and corrective actions;

• recalls and stop-sale measures;

• shortage considerations;

• cooperation during inspections;

• foreign manufacturer oversight;

• enforcement escalation and prosecution risks.

For companies placing medical devices on the Canadian market, the key message is that Health Canada continues to apply a risk-based and proportionate enforcement model, but retains a broad range of tools to address non-compliance where public health or regulatory integrity may be affected.