Health Canada

Medical Devices sold in Canada must meet the requirements of the Canadian Medical Device Regulations. The requirements vary depending on the classification of the device. Devices are classified according to associated risk with Class I as the lowest risk and Class IV as the highest. Manufacturers of devices designated as Class II and higher are required to have their quality system certified to ISO 13485 and obtain a device license. Device licenses must be renewed annually.

Spectre Solutions can assist you in meeting the Canadian Medical Device Regulations. We have extensive experience in developing quality systems which comply with ISO 13485. We also have experience in preparing and submitting device license applications to Health Canada.

Key Benefits

    ISO 13485 Quality System Certification Assistance.
    Choosing the Appropriate Quality Systems Registrar.
    Quality System Procedure Development.
    Preparation and Submission of Device License Applications.
    Medical Device Establishment Registrations with Health Canada.
    Adverse Event Reporting.
    Reports of Product Recalls.