Our solutions

Let Sobel guide your company through the Health Canada medical device regulatory process with precision and confidence. We offer expert support in Regulatory Affairs, Quality Management, and Risk Management, helping you secure your Medical Device Licence (MDL) and comply with Canada’s Medical Devices Regulations (SOR/98-282) — so you can focus on innovation and market growth.

Medical Device Licensing (MDL) and Health Canada Compliance

Regulatory Compliance Solutions for the Canadian Medical Device Industry

Bringing your medical device to the Canadian market requires strict adherence to Health Canada’s regulatory framework. Sobel provides tailored support to help you classify your device correctly (Class II, III, IV), prepare and submit the Medical Device Licence (MDL) application, and obtain Investigational Testing Authorization (ITA) if applicable.

We also check the alignment with Safety and Effectiveness Evidence requirements, and help you to meet Quality System compliance expectations.

With our strategic guidance, you can avoid delays, streamline your approval process, and access the Canadian medical device market efficiently!

Our Services in Regulatory Compliance Solutions

We provide expert guidance to help your medical device meet Health Canada’s requirements. Explore the key steps of the Health Canada licensing process and how Sobel can support you.

Pre-Submission Preparation

Documentation Development

Risk and Quality Management

Clinical & Biological Evaluations

Compliance & Quality Support

Regulatory Affairs Support

From gap analysis to Health Canada submissions and continuous support, following SOR/98-282.

Quality Management Support

Quality Management Support helps align your system with MDSAP & Health Canada.

Risk Management

Manage device risks with ISO 14971-based support, expert analysis, and compliance checks.

Guidance Document GD211

Guidance on the Content of Quality Management System Audit Reports.

Biological Evaluation

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

Clinical Evaluation

Specialized clinical evaluations for Canadian market entry, aligned with Health Canada.

Technical File Elaboration

Tailored guidance through every step of the regulatory process and submission files.

Trainings

Elevate your expertise with training programs aligned with Health Canada’s regulations.

In addition to Medical Device Licensing (MDL), many companies operating in Canada must also apply for a Medical Device Establishment Licence (MDEL), which is required for manufacturers, importers, and distributors of medical devices. Sobel offers strategic support throughout this process—helping you understand whether your organization requires an MDEL, preparing the necessary documentation, and supporting you through the application steps with Health Canada.

Beyond the initial licensing and registration processes, our team also provides ongoing regulatory support to help your business remain aligned with Health Canada’s evolving requirements. We assist in maintaining compliant quality management systems, preparing for audits, managing post-market surveillance documentation, and adapting to changes in regulations that may affect your operations.

Our role is to support your team with clear guidance, up-to-date expertise, and efficient project coordination—so you can confidently manage regulatory expectations while focusing on your company’s growth in the Canadian medical device market.