Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...Read More

Health Canada released the full guidance document, Pre-market Requirements for Medical Device Cybersecurity. It can be viewed at:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.htm It includes requirements such as: “Risk management is required for all medical devices throughout their life-cycle. Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are...Read More

Health Canada has recently provided a new approach for device approval as outlined in their “Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.” Canada classifies medical devices based on their potential risk, with Class I devices being lowest-risk and Class IV devices presenting the highest risk. The collaborative new approach aims to...Read More

Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of...Read More

Link updated December 2018. In November 2014, Health Canada began requiring electronic submissions of license applications for Class III and Class IV medical Devices entitled: “Guidance for Industry: Formatting of Class III and Class IV Licence Applications (Electronic and Paper Formats)” File # 14-112992-741. Certain types of CDs and DVDs are specified along with information...Read More

HealthCanada released a FAQ sheet answering basic questions about software regulated as a medical device. The document clarifies that software regulated as a medical device is software which retrieves data from a medical device in order to aid or replace a physician’s decision regarding the diagnosis or treatment of a patient. Software that transmits data...Read More

HealthCanada released “Guidance Document for Mandatory Problem Reporting for Medical Devices” on October 3, 2011. Mandatory problem reporting is intended to “improve monitoring and reduce the recurrence of incidents related to medical devices.” A mandatory problem report is required for any incident involving a medical device when the incident “relates to a failure of the...Read More

Health Canada published a notice entitled “Software Regulated as a Class I or Class II Medical device,” along with a Q&A memo to clarify what software is regulated and which regulations apply. Both documents are included at the link provided. The notice appears to indicate that any software which fits the definition of a medical...Read More

Health Canada now indicates that patient management software fits the definition of a medical 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 based on Rule 12 of the Medical Devices Regulations.”Read More

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the...Read More