Authorization of medical devices for an urgent public health need: List of medical devices no longer authorized

On this page

• What is included in this list
• Reasons for cancelling an authorization

What is included in this list

Authorizations may be cancelled for some medical devices that were initially authorized under the:

• first interim order for importing and selling medical devices during COVID-19
• second interim order for importing and selling medical devices during COVID-19
• third interim order for importing and selling medical devices during COVID-19 or
• Part 1.1 of the Medical Devices Regulations (MDR)

New devices may be added to this list as required.

It is important for health care providers and other users to check this list regularly for those products that are no longer authorized.

Reasons for cancelling an authorization

The reasons for which an authorization for importing or selling a medical device under Part 1.1 may be cancelled are outlined in sections 68.21 and 68.22 of the MDR. In all but 3 instances, the cancellation of the authorization means the devices may no longer be sold or imported in Canada.

The medical device may continue to be sold or imported in accordance with the applicable provisions of the MDR if the cancellation occurs for the following reasons.

The authorization holder:

• of a Class I medical device has been issued a medical device establishment licence (paragraph 68.22(a))
• of a Class II, III or IV medical device has been issued a medical device licence for that device (paragraph 68.22(b))
• does not comply with requirements that apply for a device that is not a UPHN medical device (paragraphs 68.21(1)(h), (i) or (j))
  • subject to section 68.35 of the MDR, a person other than the manufacturer of a device cancelled pursuant to paragraphs 68.21(1)(h), (i) or (j) may sell the device for a period of 6 months beginning on the day when the authorization is cancelled

The following table indicates when a cancellation has occurred in accordance with paragraphs 68.22(a), 68.22(b) or 68.21(1)(h), (i) or (j).

All other reasons for cancellation are indicated as "Other" in the table. In those cases, the device may no longer be sold or imported in Canada.

For more information, including the reasons for cancelling an authorization, please consult the following guidance document:

• Medical devices for an urgent public health need