TRA - Toxicological Risk Assessment for Medical Devices in Canada

A TRA Toxicological Risk Assessment is a key element to demonstrate the chemical safety of medical devices submitted to Health Canada. Sobel supports manufacturers by preparing a structured TRA Toxicological Risk Assessment aligned with ISO 10993-18 and Canadian regulatory expectations.

For who?

Medical device manufacturers seeking Health Canada market authorization
Companies based locally or internationally preparing to register medical devices for the Canadian market
Manufacturers that need a TRA Toxicological Risk Assessment based on chemical characterization results
Regulatory teams that require independent toxicological justification using existing data
Companies aiming to confirm the acceptability of identified substances under intended use conditions

Sobel provides independent toxicological expertise focused on chemical risk evaluation grounded in existing evidence.

Why do you need this service?

A TRA Toxicological Risk Assessment provides structured justification of chemical safety, supporting Health Canada expectations for material-related risk evaluation.

It allows manufacturers to define tolerable limits and safety margins based on intended use, exposure scenarios, and existing toxicological evidence.

A well-documented TRA helps identify unacceptable risks early and supports informed decisions on additional testing or risk control measures.

Toxicological risk assessment requirements for Health Canada submissions

For many medical device submissions in Canada, manufacturers must demonstrate that chemical constituents do not present unacceptable risks to patients or users. Toxicological risk assessment (TRA) integrates chemical characterization data, exposure assessment, and toxicological reference values to support biological safety evaluation and Health Canada regulatory review.

Regulatory confidence starts with toxicological justification.

Scope and data review

You provide the chemical characterization outputs, and we confirm which constituents are eligible for toxicological assessment.

Toxicological data compilation

We gather and assess existing toxicity information for identified substances or materials.

Tolerable limits and safety margins

We define tolerable limits and safety margins based on intended use, exposure assumptions, and available evidence.

Risk acceptability assessment

We assess identified risks against established criteria to determine acceptability.

Conclusions and recommendations

We identify the need for additional tests or risk control measures and include relevant analysis of clinical use history or human exposure data, when applicable.

Related
Services

Our approach supports your Canadian pathway by delivering a consistent, structured TRA Toxicological Risk Assessment aligned with internationally recognized standards accepted by Health Canada. Depending on your submission strategy, you may also need:

Biological Evaluation

Expert ISO 10993 biological evaluations for biocompatibility, safety, and regulatory success.

Technical File Elaboration

Guidance to structure technical documentation for regulatory submissions.

Gap Analysis

Submission readiness review and label review for medical devices.

Chemical safety justification aligned with Health Canada expectations

Health Canada expects manufacturers to show that identified chemical constituents do not pose unacceptable risks to patients or users. Talk to Sobel and get expert support to build a structured, evidence-based TRA Toxicological Risk Assessment for your medical device!

Still have questions? Checkout our FAQ

1. Is a TRA Toxicological Risk Assessment mandatory for Health Canada submissions?

Manufacturers are expected to demonstrate that chemical substances present in a medical device do not pose unacceptable risks. A structured TRA is a widely accepted way to support this expectation when chemical exposure is relevant.

2. Which Health Canada submissions typically require a TRA?

A TRA is commonly required for medical devices where chemical characterization identifies substances that may result in patient or user exposure. This applies across different device classes, depending on materials, contact type, and duration of exposure.

3. Is the TRA aligned with ISO standards accepted by Health Canada?

Yes. The TRA is developed in alignment with the ISO 10993 series, particularly ISO 10993-18, which is internationally recognized and commonly accepted by Health Canada as part of biological safety evaluation.

4. Can an existing TRA be updated for a Health Canada submission?

Yes. Existing toxicological assessments can be reviewed and updated to reflect current ISO standards, exposure scenarios, or Health Canada expectations, provided the underlying data are available.

5. How does a toxicological risk assessment support Health Canada approvals?

A toxicological risk assessment supports Health Canada submissions by demonstrating that chemical substances released from the medical device do not pose unacceptable risks. The TRA provides exposure calculations, toxicological justification, and safety margins that strengthen biological safety evaluation documentation.

6. Where can I find comprehensive regulatory support for medical device market submissions?

Toxicological Risk Assessment is only one component of the broader regulatory documentation required for medical device approvals. Companies seeking end-to-end regulatory assistance can explore our Medical Device Regulatory Compliance Solutions, which cover biological evaluation, technical documentation, clinical evaluation, and global market submission support.