We have just been notified by Health Canada that the revised notice concerning medical device licensing for patient management software will be issued very soon. In a nutshell, the deadline for obtaining establishment licenses for the sale of Class I medical devices is February 1, 2011. The deadline for obtaining medical device licenses for Class II devices is September 1, 2011. Health Canada is also preparing an FAQ which is not yet available.
ITAC Health encourages all members who manufacture, sell or distribute Class I or Class II patient management software to initiate the ISO 13485 certification and medical device licensing processes as soon as possible. Failure to obtain licenses by the deadlines noted above will mean that you will not be able to sell or distribute patient management software classified as Class I or Class II devices in Canada.
When the notice is available it will be posted at the following URLs.