Medical devices no longer considered to have urgent public health need status: Notice to industry

From: Health Canada
Date: July 16, 2021

Date updated: October 26, 2022

Health Canada will no longer accept applications for certain categories of medical devices under Interim Order No. 3 if it has been determined there's no longer an urgent public health need for those devices.

On this page

• Background
• Determining urgent public health need
• Medical devices that no longer have UPHN status

Background

Mechanisms in place to expedite access to medical devices during the COVID-19 pandemic include Interim Order No. 3 (IO No. 3). This interim order was signed by the Minister of Health in February 2022.

For a COVID-19 medical device to be authorized for importation or sale under IO No. 3, the Minister must determine if there is an urgent public health need (UPHN) for that device. A UPHN exists if immediate action is required to protect or improve the health of individuals or communities in Canada.

Determining urgent public health need

To determine if there's an UPHN for a medical device, Health Canada considers a number of factors, including:

• its supply and demand
• its lifecycle (how long it lasts)
• its clinical need
• the status of the COVID-19 pandemic in Canada

Each IO application for a device undergoes a UPHN assessment. If there's not enough evidence of a UPHN, the applicant will receive a screening deficiency letter asking for evidence that a UPHN exists for their medical device. An attestation from a Canadian health authority stating that a UPHN exists for that medical device is an example of such evidence.

Health Canada will reject applications that don't have enough evidence of a UPHN.

Medical devices that no longer have UPHN status

As the pandemic evolves, Health Canada is assessing whether there's an urgent public health need for certain categories of medical devices. Table 1 lists the categories of COVID-19 medical devices that no longer have UPHN status. We will reassess the status of these devices from time to time as the pandemic evolves and if the supply and demand for certain categories of devices changes.

This approach allows us to better focus resources on assessing urgently needed COVID-19 medical devices to ensure they're quickly available to Canadians.

Table 1. Categories of COVID-19 medical devices that no longer have UPHN status

Device category*	Assessment date
Thermometers	2021-07-16
Ventilators	2021-07-16
Serology tests	2022-04-01
Molecular and antigen tests that do not offer: multiplex** technology or a saliva sample or unique sample type or feature that meets a clinical or accessibility need or environmentally sustainable features	2022-10-26

*IO approval may still be possible for devices listed in Table 1 if the applicant provides enough UPHN evidence for the device. Health Canada will consider the supporting evidence and inform the applicant of the decision taken as per our service standards.

**Some COVID-19 testing devices make it possible to detect other respiratory viruses (for example, influenza A and B and respiratory syncytial virus (RSV) at the same time. These tests are referred to as multiplex.

Applications that were already authorized under the IO before the assessment date identified in Table 1 are not affected.

The Medical Devices Regulations pathway remains open for obtaining medical device establishment licences (Class I) and medical device licences (Class II to IV) for all types of medical devices. To obtain a medical device licence and medical device establishment licence under this pathway, see the following guidance documents:

• How to complete the application for a new medical device licence
• Guidance on medical device establishment licensing (GUI-0016) - Summary

If you have any questions, please contact the Medical Devices Directorate at mddpolicy-politiquesdim.sc@hc-sc.gc.ca.

Archived Categories of COVID-19 medical devices that no longer have UPHN status

For reference, we have provided the archived versions of table 1, which lists the categories of devices that had a change in their UPHN status, as well as the assessment and posting dates for this change. These tables are for reference only and are no longer applied.

Posting Date: 2022-04-01

Table 1. Categories of COVID-19 medical devices that no longer have UPHN status

Device category*	Assessment date
Thermometers	2021-07-16
Ventilators	2021-07-16
Lab-based and point-of-care molecular tests that do not offer: multiplex** technology or a nasal sample or a saliva sample or unique sample type or feature that meets a clinical need	2022-04-01
Lab-based and point-of-care antigen tests that do not offer: multiplex** technology or a nasal sample or a saliva sample or unique sample type or feature that meets a clinical need	2022-04-01
Serology tests	2022-04-01

Posting Date: 2021-08-05

Table 1. Categories of COVID-19 medical devices that no longer have UPHN status

Device category*	Assessment date
Thermometers	2021-07-16
Ventilators	2021-07-16
Lab-based molecular tests that do not offer saliva or other unique sample types	2021-08-05
Point-of-care antigen and molecular tests that can only be used with nasopharyngeal swab samples	2021-08-05
Lab-based serology tests	2021-08-05

Posting Date: 2021-07-16

Table 1. Categories of COVID-19 medical devices that no longer have UPHN status

Device category*	Assessment date
Thermometers	2021-07-16
Ventilators	2021-07-16

Related links

• Interim order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19
• Applications for medical devices under the interim order for use in relation to COVID-19: Guidance document
• COVID-19 medical devices
• Medical device application forms