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: Mexico, United States of America
