Health Canada expects medical device technical documentation to be clear, consistent, and well structured to support regulatory review. Meeting these expectations is essential to avoid delays and regulatory questions. Sobel supports manufacturers by organizing and developing documentation aligned with Canadian requirements.
Whether leveraging CE Mark documentation or starting from scratch, we support a structured and efficient technical documentation pathway in Canada.
Gaps, inconsistencies, or poorly organized documentation often lead to additional regulatory questions and submission delays.
A structured approach to technical documentation helps ensure that regulatory content supports the intended submission pathway and device classification.
Medical device technical documentation must be clearly structured and aligned with Canadian regulatory expectations to support an efficient review process.
Health Canada expects structured, consistent, and well-justified documentation aligned with the applicable regulatory framework and the characteristics of each device. Our services are designed to support the development and organization of regulatory content based on existing manufacturer documentation.
Sobel provides structured technical documentation services tailored to Canadian requirements, whether you are leveraging existing CE Mark documentation or building your file without prior European approval:
This service supports manufacturers who already hold a CE Mark and are preparing medical device technical documentation for the Canadian market. The focus is on ensuring that the documentation reflects Canadian expectations while leveraging available European technical content.
This service supports manufacturers preparing Canadian technical documentation without relying on existing CE Mark submissions. Our team compiles and structures technical documentation based on the materials provided, ensuring alignment with Canadian regulatory requirements and device-specific characteristics.
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 are unsure which material characterization pathway best fits your device, Sobel can help you identify the most appropriate scenario based on your device classification, available documentation, and regulatory objectives.
Medical device technical documentation is one element of a broader regulatory strategy. Sobel also supports manufacturers with complementary regulatory services, including:
Well-structured medical device technical documentation supports smoother regulatory reviews and reduces avoidable delays. Sobel helps manufacturers prepare clear, organized, and submission-ready technical documentation for the Canadian market. Talk to our team and build confidence in your medical device technical documentation for Canada!
1. What is medical device technical documentation in Canada?
Medical device technical documentation is the structured set of technical and regulatory information required to support a medical device application in Canada, demonstrating compliance with applicable Canadian regulations and standards.
2. Is technical documentation required for all medical device classes in Canada?
Yes. Technical documentation is required for Class II, III, and IV medical devices, with the level of detail varying according to device classification and regulatory pathway.
3. Can this service be used with or without existing CE Mark documentation?
Yes. Sobel supports technical documentation compilation both when CE Mark documentation is available and when the Canadian technical file is being developed independently.
4. Do you create technical data or testing reports as part of this service?
No. All technical documentation is compiled based on information provided by the manufacturer. The service does not include generation of new test data or technical studies.
5. How does this service help reduce regulatory delays?
By ensuring technical documentation is clearly structured, consistent, and aligned with Canadian regulatory expectations, the service helps reduce avoidable review questions and requests for clarification from Health Canada.
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