Navigating MDEL Modernization: What You Need to Know
It’s MDEL Annual Licence Review (ALR) season and, for Medical Device Establishment Licence (MDEL) holders, Health Canada’s ongoing modernization of the MDEL framework brings changes that may affect your regulatory compliance status. Understanding these changes is crucial for ensuring your organization remains compliant with the latest regulatory amendments.
Background: Why the MDEL Framework is Changing
Health Canada is modernizing the MDEL framework as part of its Forward Regulatory Plan (2024–2026) and Stock Review Plan. These changes address challenges revealed during the COVID-19 pandemic and aim to better align Canada’s requirements with other major regulatory jurisdictions, including the United States, the European Union, the United Kingdom, Australia, and Switzerland.
The goal? A more agile, flexible, and less burdensome MDEL framework for distributors and importers. However, the transition may bring some uncertainty, particularly during your next Annual Licence Review and Health Canada inspection.
What Do These Changes Mean for MDEL Holders?
Several updates to the Canadian Medical Devices Regulations (CMDR) directly impact MDEL holders. Here’s what you need to know:
1. New Terms and Conditions Authority
Effective December 14, 2024, amendments to the CMDR grant the Minister authority to impose terms and conditions on MDEL holders.
Instead of suspending or canceling an establishment licence due to non-compliance, Health Canada can now impose terms and conditions that:
- Target specific compliance concerns, and
- Allow compliant parts of your operations to continue while addressing deficiencies.
This approach is intended to be less disruptive while still enforcing accountability.
2. Enhanced Scrutiny of Mandatory Procedures
With the ability to impose terms and conditions for non-compliance, inspectors are expected to apply greater scrutiny to mandatory MDEL procedures. Key focus areas include:
- Clear and specific timelines for managing complaints, corrective actions, and recalls.
- Adherence to expanded record-keeping requirements.
MDEL holders should ensure their procedures are well-documented, up-to-date, and consistently followed.
3. Updated Recall Definition and Reporting Requirements
Amendments effective December 14, 2024 introduced changes to the definition of and reporting requirements for recalls:
- Updated definition: Recalls now include those ordered by the Minister.
- Reporting Scope: Reporting is now required only for recalls involving devices that may cause serious injury.
- Timelines: Specific notification and final report timeframes are now in place.
- Information Requirements: Specific details must be included in reports.
To stay compliant, MDEL holders must update their recall procedure and align other procedures, such as complaint handling and incident reporting with these new requirements as well.
The Bottom Line
Health Canada’s modernization of the MDEL framework offers an opportunity for improvement and alignment with global standards, with the ultimate aim of enhancing regulatory oversight while reducing unnecessary burdens on businesses. However, these changes require proactive adjustments to ensure ongoing compliance.
How PASB Can Help
PASB MedTech offers resources to support MDEL holders through this transition. Our MDEL services include:
- Assistance with MDEL applications and annual licence renewals.
- Development of compliant standard operating procedures (SOPs).
- Gap analysis of your current procedures.
- SOP updates to ensure ongoing compliance.
- Training on the new requirements.
- Inspection preparation support.
- Supplier evaluation and due diligence.
By staying informed and taking the necessary steps now, your organization can navigate these changes confidently and continue operating smoothly in Canada’s evolving regulatory landscape.
Need help navigating medical device regulatory compliance?
Contact PASB today to ensure your organization is ready for the road ahead!
PASB MedTech Solutions Inc. offers regulatory compliance and market access consulting services for the medical device industry. We support early-stage startups and established firms in navigating regulatory, quality, and technical challenges. Let us be your trusted partner in bringing your medical device to market in North America and Europe.