Medical Device Technical Documentation

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.

For who?

Whether leveraging CE Mark documentation or starting from scratch, we support a structured and efficient technical documentation pathway in Canada.

Why do you need this service?

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.

Clear technical documentation supports efficient regulatory review in Canada

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.

Clear technical documentation turns regulatory requirements into manageable steps.

Scope definition

You select the appropriate technical documentation pathway based on whether existing CE Mark documentation is available.

Documentation review

Available technical and regulatory materials are reviewed to understand content structure and identify gaps.

Technical documentation compilation

Each chapter of the technical documentation is compiled and structured in line with Canadian regulatory expectations.

Documentation outcome

You receive a structured and organized technical documentation package ready to support your Canadian regulatory submission.

Which service applies to your medical device?

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:

Class II to IV - with CE Mark

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.

Class II to IV - without CE Mark

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.

Related
Services

Medical device technical documentation is one element of a broader regulatory strategy. Sobel also supports manufacturers with complementary regulatory services, including:

Gap Analysis

Submission Readiness and Label Review for Medical Devices.

Biological Evaluation Plan & Report

BEP, BER and safety services supporting Health Canada submissions.

Medical Device License Support

Regulatory support for licensing applications and ongoing compliance.

Technical documentation — a regulatory strategy

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!

Still have questions? Checkout our FAQ

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.