Guidance on Medical devices for an urgent public health need: Cancellation

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• Cancellation
• Sell-off period

Cancellation

The Minister may cancel the authorization for importing and selling a medical device if:

• the Minister has reasonable grounds to believe that:
  • the authorization holder has contravened the Food and Drugs Act (act) or Medical Devices Regulations (MDR)
  • the risks outweigh the benefits associated with the device having regard to
    • the uncertainties relating to the benefits and risks and
    • the urgent public health need (UPHN) or absence of such a need for the device
  • the authorization holder does not have an adequate quality management system (QMS) in place
  • the health or safety of patients, users or other persons may be unduly affected by the device or
  • the authorization holder failed to comply with the terms and conditions of the authorization
• the authorization was issued on the basis of subsection 68.11(4) and the authorization or licence for sale of the medical device that has been issued by a foreign regulatory agency is suspended or cancelled
• the authorization holder does not submit additional information, documents or material to the Minister within the time limit specified in the request or
• the authorization holder does not meet additional requirements within the prescribed timelines after their medical device is removed from the UPHN list

The manufacturer will be able to voice any concerns about the Minister's intention to cancel the authorization before Health Canada issues the final decision. We will then inform the authorization holder in writing of our final decision.

Health Canada will implement compliance and enforcement measures if a medical device authorized for importation or sale under Part 1.1 of the MDR is in non-compliance.

We will cancel an authorization when:

• the authorization holder of a Class I medical device has been issued an MDEL under Part 1 of the MDR
• the authorization holder of a Class II, III or IV medical device has been issued an MDL for the same device under Part 1 of the MDR or
• the authorization holder informs the Minister that the holder has discontinued the sale of the device in Canada or asks that the authorization be cancelled

Health Canada publishes and maintains a list of medical devices that are no longer authorized in Canada. Authorizations may have been cancelled for some medical devices that were initially authorized under the first, second or third interim order. New devices may be added to the list as required.

Sell-off period

A manufacturer of a Class I device will no longer be allowed to sell the medical device when an authorization under Part 1.1 of the MDR is cancelled because the:

• manufacturer of the device that is not on the UPHN list did not apply for an medical device establishment licence (MDEL) within the prescribed timeline
• Minister refused to issue an MDEL to the manufacturer or
• manufacturer withdraws their MDEL application

A manufacturer of the Class II, III or IV device will no longer be allowed to sell the medical device when an authorization under Part 1.1 of the MDR is cancelled because the:

• manufacturer of that device that is not on the UPHN list did not provide the signed certification contract or
• manufacturer did not provide the Minister with a copy of the Medical Device Single Audit Program (MDSAP)-compliant QMS certificate within the prescribed timelines

However, importers, distributors and retailers of the device will be able to continue selling off existing stock for another 6 months, as long as the:

• stock complies with labelling requirements and
• relevant importer(s) and distributor(s) hold an active MDEL

During this additional 6-month period, since they hold an MDEL, importers and distributors of the device would still be required to comply with applicable sections of the MDR.