Health Canada has issued an update to its earlier position, and has announced its current position on certain activities associated with unapproved medical devices in Canada, and the corresponding roles and responsibilities of stakeholders and industry.
Specifically, Health Canada now advises that it is permissible for unlicensed medical devices to be included in a Request for Proposal or Information (RFP/RFI). This is a shift from its prior position that only licensed products could be the subject of an RFP/RFI. It has clarified that including unapproved medical devices in an RFP or RFI is not considered an “offer for sale” (and therefore, is permissible), provided certain conditions are met, namely:
- in the RFP/RFI, the manufacturer indicates that the product is not currently licensed for sale in Canada; and
- the manufacturer may only sell the device after a medical device license has been issued by Health Canada.
The announcement notes that facilities that import and purchase unlicensed devices may place the health and safety of staff and patients at risk. Healthcare facilities are reminded that before entering into a sale with a manufacturer they must verify that the device is licensed, given that the Medical Devices Regulations prohibit the importation and sale, including offering for sale, of a Class II, III or IV medical device unless the manufacturer of the device holds a medical device license. There are certain exceptions in the case of custom-made devices, medical devices for special access and medical devices for the purpose of conducting investigational testing, in which case other rules apply.