Software Regulated as a Medical Device in Canada

21 Mar 2011

Software that provides the only means to capture or acquire data from a medical device to aid directly in diagnosis or treatment of a patient is regulated as a medical device in Canada. In addition, if it were to exist, software that would replace a diagnostic or treatment decision made by a physician would also be regulated as a medical device in Canada. These types of software further have to be classified as Class I or Class II depending on their intended use, because classification determines pre-market requirements in Canada. Software that is only intended to store and view patient information (electronic records) is not regulated as a medical device in Canada.

Software intended for use when viewing images or extracting data in real-time in order to aid in treatment or diagnosis of a patient is considered a Class I. Specifically, Class I devices tend to be considered low risk. For example, Class I devices include hospital beds to wheel chairs. Class I medical device manufacturers must obtain an "establishment license" from Health Canada and are subject to some regulatory requirements included in the Canadian Medical Devices Regulations; however, they are exempt from quality management system requirements.

Medical device software that connects to another medical device where data can be manipulated, interpreted, edited and measured is considered a Class II in Canada. Specifically, Class II devices tend to be considered higher risk than Class I devices. For example, Class II devices include ultrasonic equipment and surgical laser instruments. Manufacturers of Class II medical devices must obtain a "device license" from Health Canada and are subject to meeting requirements of the Canadian Medical Devices Regulations, including quality system requirements. Section 32. (2) (f) of the Canadian Medical Devices Regulations require manufacturers of Class II medical devices to obtain certification to ISO 13485:2003 before applying for a device license.

But what about software regulations in the EU and the US? Check back on the April 4 blog to learn about these regulations in these markets.

To speak with an Intertek expert on this subject matter, e-mail us at askmedical@intertek.com