How to stay compliant with April 2025 medical device shortage updates
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed. On April 17, 2025, Health Canada updated the List of Medical Devices – Notification of Shortages, adding new devices that now require mandatory reporting.
If your business handles medical devices, understanding these updates is critical for maintaining compliance. Keep reading to learn more about the new requirements and how you can stay ahead.
What changed in April 2025?
Health Canada has added control syringes with Luer lock tips to the list of medical devices that require mandatory shortage and discontinuation reporting. This update strengthens Health Canada’s efforts to prevent critical device shortages that could impact patient care.
The list of medical devices for shortage notification is incorporated by reference (IBR) into the Medical Devices Regulations. This means any updates to the list are automatically enforceable without further regulatory amendments.
Who must report shortages?
Manufacturers of Class I to IV medical devices and importers of Class I devices must report shortages or discontinuations if their device is listed. Even components, accessories, or parts related to a medical device must be included in shortage reporting when applicable.
Under sections 62.23 to 62.25 of the Medical Devices Regulations, failure to report a shortage could result in compliance actions. If you are a manufacturer or importer, it is your responsibility to monitor the list and submit reports when needed.
You can find more information on the Health Canada medical device shortages web page.
What about voluntary shortage reporting?
In addition to mandatory reports, Health Canada encourages voluntary reporting for medical devices not listed but still facing potential shortages. You are encouraged to report shortages if:
- The shortage could create a safety issue for patients or users in Canada
- A substitute device, part, or component is not readily available
- The shortage is national in scope
To submit a report, you can complete the electronic shortages reporting form or the discontinuation form if applicable.
Tips to stay compliant with medical device shortage reporting
To meet Health Canada’s reporting requirements, it is important to:
- Regularly monitor the List of Medical Devices – Notification of Shortages
- Prepare internal procedures to identify potential shortages early
- Train regulatory and quality teams on how to complete shortage and discontinuation reports
- Keep detailed documentation of your shortage assessments
Taking proactive steps ensures you avoid potential penalties and helps maintain trust with your clients and partners.
How regulatory compliance experts can support you
Navigating medical device requirements can feel overwhelming, especially with frequent updates. Our team at Quality Smart Solutions is here to help you stay compliant.
We offer a full range of regulatory support services for medical device companies, including compliance guidance, documentation support, and regulatory consulting tailored to your business needs.
If you need assistance with your medical device regulatory obligations, contact us today to schedule a free consultation with one of our experts. We’re ready to help you protect your business and patients.
For further guidance, you can also consult Health Canada’s Guide to reporting medical device shortages and discontinuations (GUI-0137).
