July 7, 2021
Health Canada Medical Device Importer Requirements for DTC Sales
When dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 as amended from time to time, hereinafter the “CMDR”), there are four device classes: I, II, III, and IV. Therefore, when adapting a regulatory strategy from surrounding jurisdictions, be sure to consider the unique differences in Canada’s device classification scheme, such as with respect to the EU’s class IIa category, or such as with respect to the USA, which only has three risk classes.
The CMDR don’t demand that an importer be designated for each imported shipment or device. Rather, it has been my experience that a person automatically becomes an importer based on whether the person engages in activities that meet Health Canada’s definition for importer. Oddly enough, neither the CMDR nor its statutory counterpart (the Canadian Food and Drugs Act) define importer. But in guidance (see GUI-0016), ‘importer’ is defined as a person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device being brought into Canada for sale.
In the case of internet sales directly to consumers for personal home use, Health Canada has expressed to me in prior correspondence that such a consumer is viewed to be the importer. However, for that type of importer, neither the importer MDEL requirements (nor any other CMDR importer requirements) apply because of CMDR subsection 2(b). For example, GUI-0016 states an MDEL exemption for “any person who imports a medical device for his/her own personal use”.