Mpox (monkeypox) tests: Notice to industry

Date published: October 19, 2022

This notice is for manufacturers of in-vitro mpox (monkeypox) diagnostic tests.

On this page

• Background
• Notifications to industry
• Guidance for industry
• Contact us

Background

On July 23, 2022, the Director General of the World Health Organization (WHO) declared that the global mpox (monkeypox) outbreak is a public health emergency of international concern.

Since the beginning of the outbreak, our top priority has been protecting the health of people living in Canada. The Government of Canada is continuing to monitor the mpox (monkeypox) situation as it evolves.

Notifications to industry

At this time, the Medical Devices Directorate (MDD) classifies in vitro diagnostic tests for mpox (monkeypox) as follows:

• laboratory mpox (monkeypox) tests are Class II medical devices based on Schedule 1, Part II, Rule 2 of the Medical Devices Regulations (regulations)
• near-patient mpox (monkeypox) tests (including point of care or self-tests) are Class III medical devices based on Schedule 1, Part II, Rule 6 of the regulations

Under the regulations, Class II devices do not generally require scientific review before they come onto the Canadian market. However, we intend to ask that manufacturers submit certain data for Class II lab-based mpox (monkeypox) tests before these are approved. This is in accordance with section 35 of the regulations.

We are taking this extra step in recognition of the global mpox (monkeypox) outbreak situation.

The data we will request will include:

• analytical sensitivity data
• precision testing
• clinical data using all claimed sample types

Note: When using clinical samples to validate the device's clinical performance, the device should be compared to licensed assays (including assays authorized by the U.S. Food and Drug Administration). Otherwise, contrived samples should be used.

We will also be requiring a stability study protocol.

The information we request may change as we learn more about the performance of mpox (monkeypox) tests. We may also ask for additional information if we determine it's required to complete our assessment of a particular application.

Guidance for industry

You can access our e-learning tool for more information on how medical devices are regulated in Canada.

Please prepare any application according to the available guidance. Should you be preparing a new Class III application, please consult our guidance document on how to structure your submission.

Contact us

Email your questions or comments about this notice to MDD at meddevices-instrumentsmed@hc-sc.gc.ca.