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Class II, III or IV medical devices cannot be sold or imported in Canada without a valid medical device licence (MDL). Unlicensed devices that haven't been assessed for their safety, effectiveness and quality may pose a health risk to Canadians.

In certain situations, a Fax-back process is used. A Fax-back form (Appendix I) which is submitted by the manufacturer3 attests that all specifications have been met; receipt is acknowledged by Fax-back within 48 hours.

Health Canada requires manufacturers of Class II - IV medical devices to meet the QMS of ISO 13485 under MDSAP which includes compliance with the requirements of the CMDR. Before your device can be sold in Canada, your compliant QMS must undergo an audit by an MDSAP-accredited Auditing Organization (AO).

Section 34 of the Regulations describes five instances when a manufacturer is obliged to apply for an amended medical device licence. One of those instances is when a "significant change" is proposed to a Class III or IV device.

After the initial submission, Summary Reports must be submitted to Health Canada at periodic intervals, including a critical and concise analysis of the information received on the use of authorised devices and an indication of whether there have been any changes in the associated device's risks/benefits.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the act) established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective.