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

From: Health Canada
Date: July 16, 2021

Date updated: September 26, 2022

This notice will be updated on October 26, 2022 to communicate the updated list of COVID-19 Class IV testing devices that are no longer considered to have UPHN status. The goal of this notice is to give manufacturers who are finalizing their submissions to Health Canada advanced notice of upcoming changes to the UPHN status that may affect their applications under the interim order.

More information on the update can be found here.

*This update will not affect Class I to III medical device applications.

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.

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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:

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
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

*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:

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

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