Thank you, Madam Chair.
I'd like to thank the committee members for the opportunity to appear today.
Throughout the pandemic, the Public Health Agency of Canada and Health Canada have worked to facilitate the distribution of medical supplies and equipment to provinces and territories to support Canada’s COVID‑19 response.
In March 2020, Health Canada and the Public Health Agency worked closely with partners for the provision of timely and accurate data related to purchased personal protective equipment, or PPE, and medical devices, including those shipped to the provinces and territories. As part of this, as mentioned in the Auditor General's report, we developed a supply-and-demand modelling tool that allowed us to assess the sufficiency of stocks held by federal and provincial or territorial holdings, along with expected deliveries, and then compared these to the anticipated demand for PPE across the economy, in particular in the health sector, and with the modelling informed by an epidemiological model in terms of the expected demand for different health scenarios.
Health Canada's role as it pertains to recommendation 10.82 of the report concerns authorizing the sale of medical devices in Canada. Health Canada regulates the advertising, importation and sale of medical devices. This includes diagnostic tests, ventilators, swabs and PPE.
The regulation of medical devices in Canada is based on risk. Devices are classified into four classes, with class I presenting the lowest potential risk and class IV the highest risk. Under this system, all medical devices, including respirators, are subject to the safety and effectiveness requirements of the medical devices regulations.
Under the regular regulatory framework, only higher-risk devices, classes III and IV, are subject to a premarket scientific review. Respirators are class I devices and therefore do not require device-specific premarket authorization under the regular authorization process. The establishments manufacturing, importing and distributing class I devices are subject to the medical device establishment licensing regulatory requirements. However, through interim orders used to introduce regulatory flexibilities in the context of the pandemic, manufacturers have the choice between two authorization pathways for class I medical devices: the new interim order pathway and the regular medical device establishment licensing pathway.
Under the interim order pathway, manufacturers of class I devices submit an application to demonstrate the safety, effectiveness and quality of their medical device. Health Canada conducts a scientific review of the application before authorizing the sale of these devices. Alternatively, manufacturers of class I devices can obtain a medical device establishment licence from Health Canada, which is the regular authorization pathway for class I devices. Under this pathway, the department maintains regulatory oversight of products coming onto the Canadian market through establishment inspections and compliance verifications to identify risks. Officials make admissibility decisions on products received at the border.
Regardless of the pathway chosen, all medical devices are subject to the safety and effectiveness requirements of the medical devices regulations, and companies are required to provide Health Canada with information promptly, if requested.
In report 10, the OAG asked Health Canada to determine whether respirators are appropriately classified, given that class I medical devices are not subject to a Health Canada review of safety and effectiveness information under the regular regulatory authorization process. This is why Health Canada has been conducting premarket evaluations of all applications for Canadian respirators received under the medical device interim orders, even though they are class I. We will continue to do so as long as this alternative regulatory pathway remains in effect.
In addition, in response to recommendation 10.82, Health Canada agrees with the Auditor General and has already convened a team to begin assessing the classification rules associated with lower risk devices, including respirators.
As indicated in the Management Response and Action Plan, Health Canada will complete a thorough analysis of the classification of respirators.
Madam Chair, I'd like to thank the committee for inviting me. I'd be pleased to answer any questions you may have.