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In a Nov 5 email bulletin to members, Brendan Seaton, President of ITAC Health stated the following:

(Note: This blog posting is directed primarily at EMR vendors and software developers - Ed)

ITAC Health has learned that Health Canada is planning to issue revised guidance in the form of an FAQ that will redefine Patient Management Software.  It is expected that the new definition will be more restrictive than the definition in their May 21st Notice. It is likely than many patient management software products previously identified as Class I and Class II devices will no longer fit the new definition and will NOT require Medical Device Licenses. Health Canada has advised that they plan to issue the FAQ before the end of November.
 
ITAC Health recommends that health software manufacturers and vendors contact Health Canada's Medical Devices Bureau to confirm the status of their products. This includes products on which Health Canada had previously rendered classification decisions.

Contact information for Health Canada follows:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605, Statistics Canada Main Building
Tunney's Pasture, Address Locator 0301H1
Ottawa, Ontario
K1A 0K9
Phone: (613) 957-7285
Fax: (613) 957-6345
E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 Read an earlier blog posting - ITAC Health - Are EMRs Medical Devices?

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Read More: http://blog.canadianemr.ca/canadianemr/2010/11/itac-health-class-1-and-2-devices.html