Written by Dominique T. Hussey and Melissa M. Dimilta
As a result of the COVID-19 pandemic, protective medical equipment including masks and gowns, and medical devices for use in testing and treating COVID-19 patients are in high demand. Manufacturers of these medical devices are attempting to scale up production in the face of supply shortages while industry and government are innovating to address the issue.
To expedite the sales authorization of medical devices for use in relation to COVID-19, the Canadian government issued an Interim Order on March 18 and several accompanying guidance documents that have been updated throughout the month of April. In response, manufacturers and importers in a variety of industries have pivoted their businesses to try to produce or import essential medical devices in high demand.
Medical Device Regulations in Canada
The term "medical devices", as defined under the Food and Drugs Act (RSC 1985, c F-27, s. 2), covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. This definition covers ventilators and COVID-19 test kits, and all personal protective equipment (PPE), including masks and gowns used by health care professionals. The term would not include PPE that is not sold or represented for medical use, such as masks that can be purchased at a hardware store.
There are four classes of medical devices—Classes I, II, III and IV—which broadly correspond to the level of risk associated with the device. As defined by classification rules set out in Schedule 1 of the Medical Devices Regulations (SOR/98-282, s. 2), Class I represents the lowest risk and Class IV represents the highest risk. Most PPE falls under Class I; sterilizers and thermometers tend to fall under Class II; and ventilators and testing kits tend to fall under Class III or IV.
There are two types of licences required for medical devices: the device licence and the establishment licence. Generally, a medical device licence is issued to the manufacturer of the medical device and is only required for Class II, III and IV medical devices. An establishment licence is issued to either the manufacturer or the importer of the medical device and is required for the importation or sale of any medical device, with certain exceptions.
COVID-19 Medical Device Authorizations
Following the Interim Order, Health Canada has issued and been updating guidelines on expediting the authorization of COVID-19 medical devices that are new and not yet licensed in Canada, existing licensed devices for COVID-19 related uses, and medical devices authorized by a trusted foreign regulatory authority.
Under the Interim Order, manufacturers or importers of COVID-19 medical devices are exempt from the requirements of an establishment licence if Health Canada has issued an authorization for the sale of the medical device. Accordingly, manufacturers or importers of COVID-19 medical devices such as Class I masks, can obtain an authorization for the device without holding an establishment licence, which can take a long time for first-time applicants to obtain. Relief from this requirement has been key to allowing manufacturing businesses in different industries to adapt their businesses to address supply shortages. The Interim Order also provides that COVID-19 medical devices are exempt from the requirement to file licence applications for Class II, III or IV medical devices where an authorization has been granted.
The guidance provides the information required in an application for expedited approval to import or sell a COVID-19 medical device, including labelling requirements as well as record keeping and reporting obligations. COVID-19 medical devices are exempt from the strict Mandatory Reporting requirements under the Medical Devices Regulations but manufacturers or importers of COVID-19 medical devices must still report any incident to Health Canada within 10 days and must follow the recall procedures provided for under the Regulations.
In addition, Health Canada provides specific guidance on the pathways for expedited approval of personal protective equipment, masks and respirators, ventilators, diagnostic tests, medical gowns, and medical gloves. Health Canada encourages stakeholders to refer to the US FDA's guidance document, "Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency," in addition to Health Canada's required review elements when compiling their submissions to Health Canada for expedited approval of ventilators and other respiratory devices and their accessories.
Importing COVID-19 Medical Devices
The Interim Order relaxes the usual requirements for importers of medical devices. As is the case with local manufacturers of medical devices, importers do not need an establishment licence if Health Canada has issued an authorization for the importation of the device.
Further, if a medical device has been and is approved by a trusted foreign authority the requirements for the submission of the medical device authorization are reduced. In those circumstances, for example, an importer of a COVID-19 medical device would not need to provide information in relation to the quality, safety and effectiveness of the device.
Health Canada issued another Interim Order on March 30, 2020, allowing for the exceptional importation and sale of drugs, medical devices and foods for special dietary purposes specifically identified by Health Canada as being in short supply due to the COVID-19 pandemic. This Interim Order allows holders of Canadian Drug Establishment Licences to import designated drugs, medical devices and foods without meeting the full complement regulatory requirements. The Interim Order relaxes a variety of drug labelling, sampling and release requirements. The Minister maintains up-to-date lists of the drugs, medical devices, and foods eligible for this exceptional importation pathway on Health Canada's website.
To date, the fast-track initiative appears to have been a success. More than 125 protective, treating and diagnostic medical devices have been authorized for importation or sale by Canadian and international companies to address the urgent need for COVID-19 tests, PPE, ventilators, sterilizing solutions and thermometers.
If your business or organization has questions respecting the authorization of COVID-19 medical devices, please contact us. In addition, please visit our COVID-19 Resource Centre for other COVID-19-related materials.