Authorized medical devices for uses related to COVID-19: List of products no longer authorized under IO

On this page

• What is included in this list
• Reasons for authorization being removed
• Non-compliance with a request for additional information

What is included in this list

Authorizations may be revoked for some medical devices that were 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 or
• most recent interim order for importing and selling medical devices during COVID-19

New devices may be added to this list as required.

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

Reasons for authorization being removed

There are 5 reasons for removing authorization under (IO) No. 3:

1. The risks outweigh the benefits.
2. The terms and conditions were not met.
3. A foreign regulatory authority cancelled its authorization.
4. The manufacturer received a medical device licence.
5. The manufacturer is no longer marketing the device.

Risks outweigh benefits

Under paragraph 8(a) of IO No. 3, the Minister may cancel a device's authorization if there is enough evidence showing:

• the risks of using the device are greater than the benefits or
• the health or well-being of patients who use the device may be negatively affected

Terms and conditions not met

Under paragraph 8(b) of IO No. 3, the Minister may cancel a device's authorization if the terms and conditions placed on the authorization are not being met.

Authorization cancelled by a foreign regulatory authority

Under paragraph 8(d) of IO No. 3, the Minister may cancel a device's authorization if the foreign regulatory authority has cancelled or suspended the authorization for sale. Foreign regulatory authorities include the U.S. Food and Drug Administration, the Australian Therapeutic Goods Administration and others.

Licence issued

Under paragraph 8(c) of IO No. 3, the Minister may cancel a device's authorization if the manufacturer has received a medical device licence under the Medical Devices Regulations. The licence confirms that the device continues to meet regulatory requirements and is safe for people to use.

Marketing has ceased

The manufacturer has asked Health Canada to cancel the authorization because the manufacturer is no longer selling the device in Canada.

Non-compliance with a request for additional information

Under section 9, the Minister may cancel an authorization if Health Canada has sent the manufacturer a request for:

• additional information or material, including samples
• a date by which the manufacturer must respond and the manufacturer has not responded by that date