Collaboration with the Public Health Agency of Canada’s National Microbiology Lab

Date published: August 17, 2020

The Public Health Agency of Canada’s National Microbiology Lab (PHAC-NML) will conduct independent scientific laboratory evaluation of some COVID-19 testing devices when requested by Health Canada. The evaluations will include an assessment of the sensitivity and specificity of the testing devices. The results of these evaluations will be shared with Health Canada to support decision making.

It is still the manufacturer’s obligation to provide Health Canada with enough information about the quality, safety and effectiveness of the testing device to determine whether to authorize or license the device.

The evaluation by PHAC-NML provides independent information to:

• support pre-market review
• confirm or refute manufacturer claims
• support decision making for devices already on the market

The devices referred to PHAC-NML for scientific evaluation by Health Canada include test devices with potentially good performance (such as data to support good sensitivity or specificity) and:

• that are fundamentally different from others in its class
• from manufacturers that are new to the Canadian regulatory environment for medical devices
• from manufacturers that provided sufficient but limited information to support an authorization or licence

The manufacturer will be notified by Health Canada if their testing device is referred to PHAC-NML.

PHAC-NML may also evaluate testing devices requested by manufacturers on a case-by-case basis provided that it has the capacity as well as the scientific and public health mandate to do so. PHAC-NML will provide the results of these evaluations to:

• the manufacturer
• Health Canada, to help make licensing and post-market regulatory decisions