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

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What is included in this list

Some medical devices are no longer authorized under the interim order (IO) for importing and selling medical devices during COVID-19. It is important for health care professionals and other users to check this list regularly for those products no longer authorized under the IO.

Reasons for authorization being removed

There are 5 reasons for removing IO authorization:

  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 section 8(a) of the IO, the Minister may cancel a device’s authorization if there is enough evidence showing:

Terms and conditions not met

Under Section 8(b) of the IO, 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 Section 8(d) of the IO, 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 Section 8(c) of the IO, 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. 

List of COVID-19 medical devices no longer authorized
Device name Manufacturer IO authorization number Date the notice of cancellation was issued Reason for cancellation
Spartan Cube COVID-19 System Spartan Bioscience Inc. (Canada) 313012 2021-01-22 Terms and conditions were not met
Ventilator Battery Interstate All Battery 314497 2020-10-16 Licence issued
KN95 Non-Powered Air Purifying Particle Respirator Senke Pharmaceutical (Chengdu) Co., Ltd 313083 2020-05-08 Risks outweigh benefits
DTC3X N95 Particulate Respirator Shanghai Dasheng Health Products Manufacture Co., Ltd. 314322 2020-06-17 Risks outweigh benefits 
Respirator Disposable Face Mask (KN95) Groupe Ricochet Inc. 312817 2020-06-23 Risks outweigh benefits 
Mapleswab Swabs Shapetry Labs Inc. 314196 2020-06-30 Risks outweigh benefits
Protective Respirator (N95 Masks) Hunan Triplex Precision Medical Devices Co. Ltd 313261 2020-08-20 Risks outweigh benefits
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