Purchasing Licensed Medical Devices for Healthcare Use – Health Canada Guidance

Why Licensing Matters

In Canada, medical devices are classified from Class I (lowest risk) to Class IV (highest risk). Only Class II, III, and IV devices require individual device licences issued by Health Canada before they can be legally sold or imported for use in healthcare settings. Purchasing unlicensed devices exposes patients to unassessed risks, may violate federal regulations, and can result in professional liability or institutional sanctions. Class I devices do not require device licences but must be sold by licensed medical device establishment licence (MDEL) holders. Purchase Licensed Medical Devices for Use in Health Care - Canada.ca

Steps to Ensure You Purchase Licensed Devices

Healthcare purchasers should follow these key steps:

• Verify the device is licensed: Use the Medical Devices Active Licence Listing (MDALL) to search for the device by name, model, licence number, or manufacturer. Confirm the licence is active and matches the exact product version.
• Purchase from legitimate sources: Obtain devices directly from the licence holder or from distributors authorized by the licence holder. Ask suppliers to provide proof of licensing and authorization.
• Request documentation: Obtain copies of the device licence, instructions for use (in English and French where required), and any relevant certificates (e.g., ISO 13485).
• Check for compliance markings: Licensed devices typically bear the Health Canada licence number or other identifiers; be cautious of products lacking proper labelling.

Risks of Unlicensed or Counterfeit Devices

Unlicensed devices may not have undergone Health Canada’s safety and effectiveness review, potentially leading to:

• Substandard performance or failure.
• Increased risk of adverse events or infections.
• Legal and financial consequences for the purchaser or facility.

Counterfeit devices pose additional dangers due to unknown materials, poor quality control, and lack of traceability.

Special Cases and Exceptions

• Investigational testing: Devices used in clinical studies require investigational testing authorization, not a full licence.
• Special access: In rare cases, unlicensed devices may be accessed via the Special Access Programme for emergency or compassionate use.
• Custom-made devices: Certain custom devices are exempt from licensing but must meet specific conditions.

Routine clinical use should always involve licensed devices unless covered by these exceptions.

Practical Recommendations

• Establish internal procurement policies requiring MDALL verification.
• Train purchasing staff on how to check licences and identify red flags.
• Maintain records of licence verification for audits.
• Report suspected unlicensed or counterfeit devices to Health Canada via the Medical Devices Problem Reporting form.

By purchasing only licensed medical devices, healthcare organizations help ensure patient safety, support regulatory compliance, and contribute to effective post-market surveillance in Canada. Detailed verification steps, MDALL search links, and reporting resources are available on the Health Canada purchasing guidance page. Purchase Licensed Medical Devices for Use in Health Care - Canada.ca