On March 24, 2020, Health Canada announced its plan to fast-track the Medical Device Establishment License (“MDEL”) application process for companies that want to manufacture, import, or distribute Class I masks.
Health Canada also loosened its restrictions for parties interested in importing or distributing non-compliant masks and respirators, including those (i) past their expiry date; (ii) that are non-medical grade; or (iii) that may not have a bilingual label. The steps for requesting a fast-tracked MDEL application for Class I masks and for permission to import non-compliant masks can be found here.
According to Health Canada, masks and respirators (personal respiratory protective devices) are essential during the COVID-19 outbreak to help slow the spread of the disease in Canada and improve protection for heath care providers. The Public Health Agency of Canada (“PHAC”) defines the terms Mask and Respirator as follows:
- Mask: “a barrier to prevent droplets from an infected source from contaminating the skin and mucous membranes of the nose and mouth of the wearer, or to trap droplets expelled by the wearer, depending on the intended use.”
- Respirator: “a device that is tested and certified by procedures established by testing and certification agencies recognized by the authority having jurisdiction and is used to protect the user from inhaling a hazardous atmosphere. The most common respirator used in health care is a N95 half-face piece filtering respirator. It is a personal protective device that fits tightly around the nose and mouth of the wearer, and is used to reduce the risk of inhaling hazardous airborne particles and aerosols, including dust particles and infectious agents.”
The most common respirators used in health care are the N95 respirators, which are Class I medical devices manufactured by companies that hold an MDEL. When worn properly, Health Canada has stated that N95 respirators achieve a minimum filtration efficiency of 95%, and also protect against exposure to respiratory viruses and bacteria. Health Canada’s view is that masks can protect individuals from the transfer of micro-organisms, body fluids, and particulate material. Unlike N95 respirators, Health Canada also cautions that masks are looser in fit and as a result, they do not provide the same level of filtration.
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