Health Canada to Scale Back Definition of Patient Management Software

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: device_licensing@hc-sc.gc.ca