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 physician.
- software regulated as a Class I medical device will include
- 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 include
- 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 range.
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.
Footnotes
1 A copy of the notice can be found here.
2 A copy of the FAQ can be found here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.