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

From: Health Canada
Date: July 16, 2021

As of July 16, 2021, Health Canada will no longer accept applications for certain categories of medical devices under Interim Order No. 2 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. 2 (IO No. 2). This interim order was signed by the Minister of Health in March 2021.

For a COVID-19 medical device to be authorized for importation or sale under IO No. 2, 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 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 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

*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.

The device categories listed in Table 1 only affect applications filed after the assessment date identified in the table. Applications that were submitted before that date and are still being processed or authorizations already issued under the IO before that date 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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