Who can sell PPE in Canada?
Retailers that want to sell Personal Protective Equipment (PPE) that is to be used in medical settings in Canada have to receive authorization to do so from Health Canada. PPE such as surgical masks, gloves, gowns, N95 respirators and face shields are considered medical devices. Here in Canada, medical devices are classified based on the level of risk that they pose. They can vary from Class I, II, III or IV medical devices, with Class I devices posing minimal risk and Class IV devices posing the highest risk. Most PPE, such as surgical masks, N95 respirators, gowns and face shields, are considered Class I medical devices while gloves are considered Class II medical devices. Companies need to obtain the appropriate licences through Health Canada to manufacture, import and/or distribute medical devices.
What are the different types of licences?
The type of licence that is required for authorization depends on the class of the medical device and whether the company manufactures, imports or distributes the devices. There are two types of licences that can be issued by Health Canada: The Medical Device Licence (MDL) and the Medical Device Establishment Licence (MDEL).
A MDL is a licence that is issued to the individual medical device. Manufactures that wish to import or distribute Class II, III, or IV medical devices are required to get a MDL for each device. In order to obtain this licence, manufacturers must present evidence of their devices’ safety, quality and effectiveness to the Medical Devices Bureau of the Therapeutics Products Directorate. Most PPE do not require a MDL as they are Class I medical devices with the exception of medical gloves, which are Class II devices.
A MDEL is a licence that is issued to any person or company that will be importing and/or distributing the medical devices of all classes for human use in Canada. Manufacturers of Class I medical devices, such as most PPE, are also issued a MDEL in order to import or sell their devices in Canada. A MDEL guarantees that medical devices being imported and sold in Canada meet safety requirements outlined in the Medical Devices Regulations. It also allows Health Canada to keep track of importers and distributors both inside and outside the country that are selling to Canadian facilities, and manufacturers that are either selling their own Class I devices or through a distributor that has an MDEL. As a North America-based manufacturer and distributor of various medical PPE, Penguin Health has all the necessary licences for authorization by Health Canada to manufacture and distribute their products here in Canada.
Due to the rise in demand for PPE as a result of the ongoing pandemic, Health Canada has been fast-tracking authorization for manufacturers to import and sell medical devices of all classes through the Interim Order Authorization. With the Interim Order Authorization, manufacturers and importers can sell medical devices without an MDEL in order to meet the increasing demand.