The first Interim Order issued by Health Canada (HC) to govern the importation and sale of medical devices needed to diagnose or treat COVID-19 has expired, and the agency has put in place a new IO to seamlessly continue the provisions laid out in the first. The government body announced this plan in November 2020, stating its intention to subsequently prepare transition regulations that would provide manufacturers with flexibility beyond the second IO’s expiration date.
The impact of the transition from one IO to another may be summarised as follows:
All active authorisations and expanded use indications authorised under Interim Order No. 1 will be considered as authorisations under IO No. 2 with no action required by the manufacturer.
Manufacturers may continue to import and sell their devices in Canada under IO No. 2 as under No. 1.
Any terms and conditions placed on an IO authorisation issued under IO No. 1 remain in effect under No. 2, and manufacturers should continue to operate under them.
All applications made under IO No. 1 and still in process will be considered current under No. 2, including amendment applications, with no action required by the manufacturer.
Health Canada takes steps to curb inappropriate use of RUO labelling
The Canadian regulator also issued a notice to clarify the conditions under which a commercial COVID-19 testing device may be labelled "For Research Use Only” (RUO). Devices classified as RUO are exempt from the requirements of the Medical Devices Regulations (CMDR) and the second IO cited above, and HC is seeking to ensure that RUO labelling is only applied to eligible devices. The action is spurred by concerns that unauthorised testing devices labeled as RUO but intended for purposes other than research are being marketed in Canada.
In the notice, HC clarifies that the use of RUO labelling is intended specifically for medical devices in the laboratory research phase of development. Devices labeled as such may not be used for clinical trials or clinical diagnosis, screening, or surveillance, even if they subsequently receive regulatory authorisation from HC. Only commercial testing devices authorised by HC may be imported or sold in Canada, whether for general use (including personal use) or for clinical trial purposes.
An exception to this rule occurs when HC has received a submission to authorise a commercial testing device used for COVID-19 and samples must be assessed or validated by a public or private laboratory. This also applies when HC has issued a formal request for samples. In such cases, devices may be given RUO labelling in order to be imported and distributed to the specific laboratory.