New Health Canada Guidance on Special Access for Unlicensed Medical Devices


Food and Drug Law
Food and Drug Regulatory LawUnder the Special Access Programme, health care professionals can apply to Health Canada for authorization to import medical devices that are not licensed for sale in Canada. These requests are approved in circumstances of emergency use, or if conventional therapies have failed, are unavailable or are unsuitable. 

Special access is normally requested for a particular patient for immediate use, but the Guidance indicates that a batch request is appropriate when a health care professional requires access to the device for anticipated emergency cases where licensed medical devices are unavailable, and where shipping delays would result in adverse patient outcomes.

The Guidance is available here.

Follow our FDL updates us on Twitter: @TorysFDL 

MailClick here to subscribe to Torys' insights and updates