Health Canada has announced its position on certain activities associated with unapproved medical devices and the corresponding roles and responsibilities of stakeholders and industry, updating its earlier position in doing so.
Specifically, Health Canada now advises that unlicensed medical devices can be included in a request for proposal or information. This is a shift from its prior position that only licensed products could be the subject of a request for proposal or information. It has clarified that including unapproved medical devices in a request for proposal or information is not considered an 'offer for sale' (and is therefore permissible), provided that the following conditions are met:
- In the request for proposal or information, the manufacturer indicates that the product is not licensed for sale in Canada; and
- The manufacturer sells the device only after a medical device licence 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 import 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 licence. Certain exceptions apply in the case of custom-made devices, medical devices for special access and medical devices for the purpose of conducting investigational testing, to which other rules apply.
For further information on this topic please contact Adrienne M Blanchard at Norton Rose Fulbright Canada LLP by telephone (+1 514 847 4747), fax (+1 514 286 5474) or email ([email protected]). The Norton Rose Fulbright Canada website can be accessed at www.nortonrosefulbright.com/ca.
