Health Canada Medical Device Labelling Guidelines: A Guide

Health Canada medical device labelling guidelines are designed to ensure the device’s use is clearly understood by users. These guidelines help patients and practitioners use the device as intended. Hence, the medical device labelling guidelines have a role in device safety and effectiveness. The labelling guidelines are primarily outlined in Section 21–23 of the Canadian Medical Device Regulation (CMDR). Notably, the labelling guidelines vary based on the medical device’s classification. Higher-risk devices require more detailed technical documentation in their labelling than low risk devices. The medical device labelling guidelines are detailed and nuanced. They have been designed to ensure safety, transparency, and bilingual accessibility for Canadian users. In this blog, we will dive into Health Canada guidelines for labelling medical devices.

Health Canada medical device labelling guidelines

We have provided detailed information on Health Canada medical device labelling guidelines. The languages to be used for labelling medical devices intended for the Canadian market are English and French. Further details on the guidelines are available on Health Canda’s guidance document on medical device labelling. As per Canadian guidelines, every medical device label must include:

• Device name: Trade name and model/catalogue number
• Manufacturer information: Name and address (must be clearly visible)
• Control number: Lot, batch, serial number, or other identifier
• Expiry date: If applicable, must be clearly stated
• Intended use: Purpose and indications for use
• Directions for use: Installation, operation, maintenance instructions
• Risk information: Warnings, precautions, contraindications
• Sterility status: If sterile, include method and expiry date
• Quantity: Number of units per package

Key highlights from Health Canada guidance document for labelling medical devices

The official guidance document mentions certain regulatory expectations. We have highlighted some important information:

• Clarity and legibility: Labels must be easy to read and understand by the intended user.
• Durability: Information must remain legible throughout the device’s shelf life.
• Symbols: Use of internationally recognized symbols is permitted. However, they must be explained in accompanying documentation.
• Electronic labelling: Permitted under specific conditions for certain devices (e.g., software-based IVDs).

Different guidelines for different medical device class

The labelling requirements and expectations are directly associated with the risk class of the device. 

• Class I medical devices: Basic labelling information for safe use of the device should be provided.
• Classes II, III, IV medical devices: Extensive and detailed technical information is required to ensure compliance with the Canadian Medical Device Regulation (CMDR). Detailed risk disclosures and clinical performance summaries have to be provided for these high-risk devices. Additional documentation, such as package inserts, beyond the label may be required for higher risk medical devices.

Symbol use and labelling standard guidelines

• Symbols must conform with ISO 15223-1 and ISO 20417 guidelines.
• If symbols are used, they must be explained in accompanying documentation unless universally recognized
• Health Canada accepts harmonized symbols used in EU and FDA submissions. However, clarity on symbols is key.

Electronic labelling

Electronic labelling is permitted for certain devices, such as software-based IVDs, under strict conditions. Accessibility and durability should be informed. Importantly, users must be informed how to access the label electronically.

Specific guidelines for IVDs

In vitro diagnostic devices (IVDs) labels require additional details. The labels for IVDs should include specimen type, test method, performance characteristics, and limitations. Additionally, interpretation guidance and warnings about cross-reactivity are essential.

Best practices for Health Canada medical device labelling guidelines compliance

We have provided some best practices to help you easily comply with Health Canada medical device labelling guidelines.

• Develop a labelling checklist aligned with Canadian Medical Device Regulation.
• Include Unique Device Identifier (UDI), if applicable.
• Conduct label validation testing for readability and durability.
• Ensure change control and CAPA integration for label updates.

Medical device labelling checklist: A step-by-step guide to compliance with Health Canada guidelines

1. General label information required per Health Canada medical device labelling guidelines

• Device name and model/catalogue number
• Manufacturer’s name and address
• Device identifier (UDI if applicable)
• Lot number, serial number, or control number
• Expiry date (if applicable)
• Date of manufacture (if required)
• Quantity of contents (e.g., number of units per package)
• Storage and handling conditions

2. Regulatory essentials

• Intended use or purpose of the device
• Directions for use (installation, operation, maintenance)
• Warnings, precautions, and contraindications
• Sterility status and method (if applicable)
• Classification and licensing information (e.g., Health Canada Device Class)
• Language compliance (English and French)
• Symbols explained in accompanying documentation

3. Special considerations for IVDs

• Specimen type and collection instructions
• Test method and interpretation guidance
• Analytical performance characteristics
• Limitations and cross-reactivity warnings

4. Packaging and presentation

• Outer packaging label matches inner label
• Label is legible, durable, and securely affixed
• Tamper-evident features (if applicable)
• Electronic labelling compliance (if used)
• Environmental symbols (e.g., recycling, disposal)

5. Quality system integration

• Label design and approval documented in QMS
• Change control process for label updates
• CAPA linkage for label-related complaints or nonconformities
• Label validation testing (e.g., readability, adhesion, durability)
• Traceability maintained across production batches

What are the penalties for non-compliance with Health Canada medical device labelling guidelines?

Labelling guideline non-compliance can warrant serious regulatory actions. The severity of the actions will depend on the potential harm to public health, the nature of the violation, and the compliance history of the manufacturer. Health Canada also assesses the degree of risk to health and safety, whether the non-compliance was deliberate or accidental, and device classification. Also, the population affected is evaluated prior to implementing an action.

4 common types of non-compliance

1. Missing or incorrect labelling (e.g. no French translation, absent warnings)
2. Misleading claims or unapproved indications
3. Failure to update labels after design or risk changes
4. Inadequate traceability (e.g. missing lot or serial numbers)

Actions implemented by Health Canada

Depending on severity, risk, and impact, Health Canada may take one or more of the following actions:

1. Compliance promotion: Education and guidance to help manufacturers meet requirements
2. Compliance monitoring: Inspections and document reviews may be performed. Also, it may ask for corrective actions or label updates.
3. Regulatory actions: Sale may be stopped or import may be banned. Moreover, licence may be suspended or cancelled. Public advisories or safety alerts may be issued. Additionally, mandatory recalls or seizure of products may be ordered. Furthermore, there may be prosecution under the Food and Drugs Act, which may include fines or imprisonment.

How to appeal to Health Canada if a penalty is imposed?

If Health Canada imposes a penalty, such as a licence refusal, suspension, or stop-sale order, you may request a formal reconsideration under the Medical Devices Regulations, Section 38(3).

• Reconsideration process: You can request reconsideration for rejection or refusal of a medical device licence or amendment. Also, you can request for reconsideration for decisions based on methodology, data interpretation, or risk-benefit assessment. Notably, submit your request within 30 calendar days of receiving the decision letter. Your submission should include a copy of the negative decision letter and a detailed rationale for each issue being contested. Additionally, references to previously submitted data and completed request for reconsideration form have to be provided.
• Appeal review process: Independent experts assess your request. Recommendation goes to the Director General of the Medical Devices Directorate. Then, the Decision may be upheld, partially amended, or fully amended.
• Tips for a successful appeal: Align your appeal with ISO 13485 and risk-based thinking. Additionally, reference CAPA actions or internal audits that support your position. Notably, ensure clarity, structure, and regulatory precision in your submission.

Health Canada medical device labelling guidelines have been formulated for the correct use of the device, thereby ensuring patient safety. Need help navigating the Health Canada guidelines for labelling medical devices? Drop an email at [email protected] or call/Whatsapp on 9996859227.