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:
- The risks outweigh the benefits.
- The terms and conditions were not met.
- A foreign regulatory authority cancelled its authorization.
- The manufacturer received a medical device licence.
- 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:
- 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 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.
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.
|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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