The Medical Devices Bureau of Health Canada (the Bureau) expects
that all Class I Medical Device software marketed in Canada will be
compliant with the Medical Devices Regulations (the
Regulations) by February 1, 2011, and all Class II Medical Device
software will be compliant by September 1, 2011.
Classifying Medical Device Software in Canada
The Bureau has been struggling in recent months to clarify which
software products are regarded as "medical devices" under
the Regulations. Furthermore, the current classification rules in
the Regulations do not clearly address the classification of
software. Because of this lack of clarity, on December 3, 2010, the
Bureau released a notice1 as well as a Frequently Asked
Questions document2 to attempt to clarify how the
Regulations will apply to software products.
The Frequently Asked Questions document states that
software will be regulated as a medical device if
it provides the only means and opportunity to capture or
acquire data from a medical device for aiding directly in diagnosis
or treatment of a patient; or
it replaces a diagnostic or treatment decision made by a
software regulated as a Class I medical device will
software that is intended to be used to view images (such as
picture archiving and communication system software) or other
real-time data as an adjunct to a monitoring device, for the
purpose of aiding in treatment or diagnosis of a patient; and
remote patient monitoring software intended to be used by a
patient in the patient's home to transmit and store data
received from a medical device.
software regulated as a Class II medical device will
software that is an adjunct to another medical device and is
involved in data manipulation, data analysis, data editing, image
generation, determination of measurements, identification of a
region of interest in an image or identification (by an alarm or
alert) of results from a monitor that are outside an established
Manufacturers and distributors of software products may wish to
conduct audits of their products to assess whether any steps are
required to comply with the Regulations.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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