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.
Sobel provides independent toxicological expertise focused on chemical risk evaluation grounded in existing evidence.
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.
A well-prepared TRA Toxicological Risk Assessment provides evidence-based justification for material safety and supports confident regulatory decision-making.
With expert-led sessions delivered online or on-site, Sobel Consultancy provides a clear pathway to understanding FDA expectations, mastering ISO 14971 risk management, and strengthening internal processes that support safe, compliant products.
A comprehensive training focused on FDA’s 21 CFR 820 requirements, including quality management expectations, inspection readiness, and practical compliance applications. This 6-hour training equips teams to understand QSR structure, responsibilities, documentation needs, and how FDA assesses quality systems.
ISO 10993 sets the framework for biological evaluation and biocompatibility assessment of medical devices. This training helps teams stay aligned with current requirements, structure biological evaluation plans, and address common issues that may impact regulatory timelines.
RDC 848/2024 replaces RDC 546/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation’s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.
The European Medical Device Regulation (MDR 2017/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.
ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.
If you’re unsure which certification applies, Sobel provides initial guidance to map the right route and ensure full compliance.
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:
Expert ISO 10993 biological evaluations for biocompatibility, safety, and regulatory success.
Guidance to structure technical documentation for regulatory submissions.
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!
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. Is chemical or material characterization included in this service?
No. Chemical or material characterization (MAT C) is not included in this service and must be completed separately. However, Sobel also offers material characterization services, which can be contracted independently when needed.
5. 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.
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