Health Canada has published a notice to manufacturers, importers and distributors on importations of commercial COVID 19 testing devices. Health Canada regulates the sale and import of medical devices, including commercial testing devices related to COVID-19.
This notice is to communicate when a commercial testing device may be labelled “For Research Use Only.” If so, it is exempt from the requirements of the Medical Devices Regulations and the interim order respecting the importation and sale of medical devices for use in relation to COVID-19.
Only commercial testing devices authorized by Health Canada can be imported or sold in Canada, whether for general use (including personal use) or for clinical trial purposes. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Through the authorization process, Health Canada confirms that authorized COVID-19 tests are well supported by evidence that indicates they will provide accurate and reliable results.
Health Canada is concerned that the advertisement, importation and sale of unauthorized testing devices labelled “For Research Use Only” but intended for purposes other than research (for example, clinical research, pilot testing) is occurring. This may lead to the use of tests that may not provide accurate or reliable results in investigational or clinical diagnostic settings. In turn, this may cause adverse health consequences to individual patients and create inaccurate public health information.
Canadians and health professionals need to be able to rely on accurate, reliable and authorized COVID-19 commercial test kits for the purposes of testing, screening and surveillance.
“For Research Use Only” labelling
The use of “For Research Use Only” labelling applies to a medical device in the laboratory research phase of development. It’s not intended for a device represented for use in clinical trial or clinical diagnosis, screening or surveillance. A commercial medical device is not considered to be in the “research phase” of development and cannot be labelled “For Research Use Only” if it:
- has validated performance characteristics
- has instructions-for-use documents citing performance claims or
- is under review for regulatory approval by Health Canada (or another regulatory jurisdiction)
More specifically, Health Canada’s guidance for classification of IVDDs states:
“IVDDs which are labelled “For Research Use Only” (and are not otherwise labelled or otherwise represented by a manufacturer for a specific diagnostic application, or labelled with specific performance characteristics, or a bibliography listing articles referring to the use of the marker for a specific application) are exempt from the Medical Devices Regulations.”
If a medical device is labelled “For Research Use Only” at the time of importation, advertisement and sale, it cannot be used for clinical trial or clinical diagnostic purposes or for other use with humans (including screening and surveillance activities). This applies even if the device subsequently receives regulatory authorization from Health Canada.
The exception to this rule, specific to COVID-19 medical devices, is if Health Canada has received a submission to authorize a commercial testing device and there is a need for samples to be submitted and assessed or validated at a public health lab or private lab. This would occur if the lab:
- was considering procuring the assay for clinical trial or clinical diagnostic purposes, or for other use with humans, and
- wanted to validate the use of the assay in their environment and on their equipment
This may also occur due to a formal request for samples from Health Canada.
In these cases, the device can be imported and distributed to the specified laboratory using “For Research Use Only” labelling. For greater clarity, the device cannot be used to conduct clinical trials or pilots, diagnostic testing or surveillance activities.
For guidance on COVID-19 medical device clinical trial regulatory requirements, please consult conducting a clinical trial.
Compliance and enforcement
The inclusion of “For Research Use Only” labelling with a testing device does not render the device exempt from other applicable requirements related to medical devices in Canada. The device requires authorization by Health Canada if it’s represented or advertised for, or intended for use in testing, pilot, screening and surveillance situations.
To determine if a medical device meets the criteria of “For Research Use Only,” Health Canada will use all available information. This includes:
- marketing material (print and electronic)
- Information on its performance characteristics or
- information on its importation or sale for purposes other than laboratory research
If it’s determined that a medical device does not meet this criteria, Health Canada will consider that the medical device was imported, advertised or sold while unauthorized.
Based on the severity of the risk posed by the regulatory non-compliance, Health Canada will determine the most appropriate level of intervention. The compliance and enforcement policy (POL-0001) describes our national compliance and enforcement approach for health products regulated under the Act and its regulations.
Our web-based platform stop illegal marketing of drugs and devices:
- raises awareness about illegal marketing of drugs and medical devices
- educates health care providers on the rules governing health product advertising in Canada
- provides a quick and easy tool to report suspected misleading marketing practices
Access to testing devices for COVID-19
Early diagnosis is critical to slowing and reducing the spread of COVID-19 in Canada. As part of the government’s broad response to the pandemic, Health Canada introduced a number of agile regulatory measures to expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards. We are committed to getting Canadians access to the tools they need to fight the spread of COVID-19 in Canada.
We have authorized a number of COVID-19 tests and continue to expedite the review of testing device submissions. For more information on the authorization process for COVID-19 testing devices, please consult testing devices for COVID-19.