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.

We review our Regulatory Information frequently; please check back often for updates

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.

 

Other North American Countries: MexicoUnited States of America

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For detailed device-specific compliance information for each market, including Canada, to expedite the preparation of your medical device or IVD registration application.

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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