Post-Market Surveillance in Canada

Compliance doesn’t end at launch — Health Canada requires ongoing safety monitoring, adverse reaction reporting, and regulatory responses. Our post-market surveillance support helps your brand manage these obligations with confidence.

For who?
Cosmetic products in amber bottles. Regulatory Affairs Cosmetics.

With Sobel, you can manage post-market surveillance as an organized, proactive process instead of reacting under pressure.

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Why do you need this service?

Adverse reactions must be monitored and reported promptly to Health Canada, as even minor delays can put your compliance at risk.

Without a structured post-market process, companies face missed deadlines, regulatory penalties, and reputational damage.

For foreign brands, managing surveillance remotely adds complexity, making expert guidance essential to avoid gaps in documentation and response.

From monitoring to reporting

Our experts help you transform ongoing obligations into a streamlined, manageable process — so your focus stays on brand growth while we handle regulatory monitoring.

Stay compliant with Health Canada post-market surveillance requirements.

Related
Services

We are your partner in managing regulatory responsibilities. Alongside post-market surveillance, you can combine this support with:

GMP Guidance

Guidance on best practices for manufacturing safe and compliant products.

Facility Registration

Complete support for registering your company with Health Canada.

Evidence of Safety Report

We compile the safety data to create a dossier certifying your cosmetic product’s safety.

Ongoing compliance support for your cosmetics in Canada

Post-market compliance is an ongoing responsibility that protects both your brand and consumers. Sobel helps you manage ongoing safety obligations, meet Health Canada’s reporting requirements, and respond with confidence to regulatory inquiries.

Contact our team today and keep your products safe, compliant, and trusted!

1. What is Health Canada post market surveillance for cosmetics?

Post-market surveillance is the continuous monitoring of cosmetic products once they are available to consumers. Health Canada requires companies to track adverse reactions, keep updated documentation, and report safety concerns within regulatory deadlines. Sobel helps you manage these obligations with clarity and consistency.

2. Does Sobel manage product recalls?

No, recall management and execution are outside the scope of this service. However, Sobel helps identify risks early and supports you in preparing documentation and responses that may reduce the chance of enforcement actions.

3. What do I need to provide for this service?

You will need to share product details, any available safety history, and your internal post-market procedures (if they exist). Based on this information, Sobel structures the monitoring process, tracks your obligations, and advises on how to handle adverse reactions or inquiries from Health Canada.

4. How long does the post-market surveillance process take?

The process is ongoing, since surveillance must continue as long as the product is marketed in Canada. Specific timelines depend on Health Canada’s requirements and the severity of the case.

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