Our solutions
Let Sobel guide your company through Health Canada’s regulatory process. We provide expert support in Regulatory Affairs, Quality Management, and Risk Management, helping you secure Medical Device Licensing (MDL) and stay compliant with Canada’s Medical Devices Regulations – so you can focus on innovation.
Health Canada compliance
Regulatory Compliance Solutions for the Canadian Medical Device Industry
Bringing your medical device to the Canadian market? Let Sobel guide you through Health Canada’s regulatory framework with expertise and precision. We provide tailored support for Medical Device Licensing (MDL), Investigational Testing Authorization (ITA), and compliance with Canada’s Medical Devices Regulations. Our strategic approach simplifies the process, minimizes delays, and helps you achieve market entry 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 Evaluation
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.
Entering the Canadian medical device market requires a deep understanding of Health Canada’s regulatory landscape. From securing Medical Device Licensing (MDL) to obtaining Investigational Testing Authorization (ITA), we provide the expertise to streamline your approval process.
Our team helps ensure that your documentation aligns with Canada’s Medical Devices Regulations (SOR/98-282), minimizing obstacles and speeding up market entry.
We also offer continuous regulatory support to help you stay adaptable, manage risks, and maintain high-quality standards.
Wherever you are in the process, we provide the strategic guidance necessary for long-term success in the Canadian medical device industry.
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