Health Canada has Clarified the approach taken by its Medical
Devices Bureau to Classify Patient Management Software as Either A
Class I Or A Class II Medical Device.
Classifying Software As A Medical Device
Not all patient management software will fit the definition of a
medical device under Canada's Medical Devices
Regulations (the Regulations), which regulate the sale of
these devices. To be designated as a medical device, the software
must be intended (as stated on the manufacturer's label) to be
used for one of the medical purposes set out in the definition of a
device in Canada's Food and Drugs Act – for
example, for use in the diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state, or
Classifying Software as a Class I or Class
Whether patient management software is a Class I or Class II
medical device affects its associated regulatory requirements and
obligations. Class I medical devices have a lower perceived risk
profile and a lower regulatory burden than Class II medical
devices. Class I medical devices do not require registration before
they are sold, although they are subject to certain other
The notice that provides the clarification and updates a notice
released in August 2009 states that "[a]ny patient management
software used only for storing, acquiring, transferring or viewing
data or images is considered a Class I medical
device."1 Software that is used for the purpose of
monitoring a physiological condition, state of health, illness or
congenital deformity will be classified as a Class II medical
device. According to the updated notice, Class II medical device
software can include patient management software that is
"involved in data manipulation, data analysis, data editing,
image generation, determination of measurements, graphing, flagging
of results, identifying a region of interest or performing
calculations" if the calculations directly affect diagnosis
and/or treatment of a patient.
The earlier notice stated that a Class II medical device may be
involved in the "transfer of data." However, this term
created uncertainty since most software transfers data in some
manner – for example, to a server for back-up storage
Application of Regulations to Open-Source
The updated notice provides that the Regulations also apply to
open-source software (which in most cases is available to users at
no cost2). The onus is on the user of the open-source
software to ensure that the software is properly licensed, and the
notice states that "the user will be liable for any unlicensed
software." Health Canada's approach, as evidenced by this
notice, is that it will look to the manufacturer, importer and/or
distributor of the patient management software to ensure that any
incorporated opensource software complies with the Regulations.
Bringing Your Software into Compliance
Health Canada has suggested that all manufacturers determine the
classification of their patient software (i.e., Class I or Class
II) by June 15, 2010. It has indicated it will be focusing its
compliance efforts on patient management software in early 2011,
first focusing on Class I patient management software in early 2011
and then on Class II patient management software in late 2011.
Health Canada is expected to soon publish "Frequently Asked
Questions" to provide additional guidance on the
classification of patient management software.
Software license agreements generally require the customer to pay fees for the software license and related services, which fees are usually based upon the duration of the license and the manner in which the customer is allowed to use the software, together with applicable taxes and withholdings.
In less than nine months, on July 1, 2017, persons affected by a contravention of Canada's anti-spam legislation will be able to invoke a private right of action to sue for compensation and potentially substantial statutory damages.
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