Medical Device Registration and Approval in Canada

General country-specific regulatory information is provided on this page for medical device registration and approval in Canada. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Canada, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Canada

REGULATORY AUTHORITY: Medical devices are regulated by Health Canada.

CLASSIFICATION SYSTEM: Medical devices are classified according to a risk-based model.

Medical Devices: Class I, Class II, Class III and Class IV.

IVD Devices: Class I, Class II, Class III and Class IV.

TIMEFRAME: The approval process varies by device class.

Medical Devices:

Class I: Class I registration is not required (except for domestic companies)

Class II: Approximately 15 days

Class III: Approximately 75 days

Class IV: Approximately 90 days

IVD Devices:

Class II: Approximately 15 days

Class III: Approximately 75 days

Class IV: Approximately 90 days

SPECIAL REQUIREMENTS:

Audits: ISO 13485 MDSAP

Technical Local Tests: No local technical tests are required.

Clinical Evaluation/Studies: No clinical evaluation studies are required.

LOCAL FEES:

Application review fees: Fees range between $405 and $ 23 012.

Manufacturer registration: No manufacturer registration fees apply.

LICENSE VALIDITY: Licenses issued in Canada must be renewed on a yearly basis.

LICENSE TRANSFER: License transfers are not applicable in Canada.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is not required.

Last updated on April 11, 2019.

Other North American Countries:

Mexico, United States of America

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