Medical Device Regulatory Requirements in Canada

Regulatory Authority Health Canada
Regulatory Authority Website Link Click Here
Device Classification I, II, III, IV
Medical Device Regulations Medical Device Regulation (SOR /98-282) | Click Here
IVD Classification I, II, III, IV
In Vitro Diagnostics Regulations Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
Device Classification Guidelines Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) | Click Here
Registration Process Guidance on how to complete the application for a new medical device licence | Click Here
Registration Timeline Class 1: 120 calendar daysClass II: 2 monthsClass III and IV: 4 to 8 months
Requirement of Authorized Representative Yes
Language Requirement Submission for Canada may be in English or French, but labeling documents must also be provided in French
Labeling Requirements

Guidance for the Labelling of Medical Devices

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Clinical Trials Information

Guidance on clinical evidence requirements for medical devices: Overview

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Database Medical Devices Establishment Licence listingMedical Devices Active Licence listing | Click Here
Fees for Submission

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. 

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Declaration of Conformity

Demonstration of conformity with recognized standards to satisfy the safety and effectiveness requirements of the canadian medical devices regulations

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Certificate of Free Sale

Certificate of Free Sale (FRM-0539)

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Reportable Incidents

As per section 59 (1)(b), follow incidents need to be reported:
1. Death of a patient, user or other person
2. Serious deterioration in the state of health of a patient, user or other person
3. Potential for death or serious deterioration in health of a patient, user or other person

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Adverse Event Reporting Timelines

Incident occuring in Canada
1. death or serious deterioration in health of the patient, user or other person : 10 calendar days
2. No death or serious deterioration but possibility of reccurence: 30 calendar days
Field Safety Corrective Action

The Medical Device Foreign Risk Notification Form includes all necessary fields and instructions to support the submission of information required by sections 61.2 and 61.3 of the Regulations (Serious Risk of Injury to Human Health).

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Recalls

Overview of recall stages
Stage 1: Identify the need to initiate a recall
Stage 2: Develop recall strategy and scope
Stage 3: Notify and correct
Stage 4: Follow up
Stage 5: Review and close recall

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Advertising and Promotions

Only health products that have been authorized for sale by Health Canada may legally be advertised in Canada.

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Additional Information

Class I requires Medical Device Establishment License whereas Class II,III, IV requires Medical Device License (MDL)
Contact Phone 613-957-2991
Contact Email hcinfo.infosc@canada.ca
Contact Address Health Canada Address Locator 1801B Ottawa, Ontario
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 07/Sep/2025

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