Health Canada has recently issued a notice that patient management software is now considered a medical device and is subject to compulsory licensing. This notice will impact any developer and/or vendor of health care software in Canada. Patient management software can be categorized as a Class I or Class II device.
Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device. Although Class I devices do not require a license, manufacturers, distributors and importers are required to obtain an establishment license.
Patient management software involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations is considered a Class II medical device, as is any primary workstation that interfaces directly with a system (imaging or other type) by acquiring data and then sending data to an image generating, viewing or storage device. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license.
Click here for a copy of the notice. More information is available on the Health Canada website at the following URL: http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php.
ITAC Health is establishing a working group to help members address this new requirement. If you are interested in participating in the working group, please contact me at firstname.lastname@example.org.