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:
1. in the RFP/RFI, the
manufacturer indicates that the product is not currently licensed
for sale in Canada; and
2. the manufacturer may only sell
the device after a medical device license has been issued by Health
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.
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