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 improve the safety and effectiveness of medical devices (beyond Canada’s already stringent requirements) via a three-part strategy described below.
1. Improve how devices get on the market
With this new approach, Health Canada aims to increase medical research, thereby increasing patient protection, beginning in early 2019. The document mentions investigational testing of medical devices, which currently may only be done by manufacturers (not independent researchers or healthcare professionals). The proposed change would allow others to apply to conduct investigational tests. Additionally, Health Canada will form a new expert advisory committee on women’s health issues for drugs and medical devices (in addition to the two existing medical device advisory committees on digital health and cardiovascular devices). Health Canada’s new division to review medical devices that involve digital health technologies will “focus on addressing safety issues related to digital health technologies such as securing private health information and preventing hacking and cyber security threats.”
2. Strengthen monitoring and follow-up of devices once they are being used by Canadians
Due to concerns of under-reporting, seven hundred and seventy-six Canadian hospitals will be required to report medical device incidents pursuant to Vanessa’s Law (beginning in February 2019). The goal of this law is to increase capabilities for surveillance and signal detection. Health Canada seeks to improve reporting from other healthcare facilities as well, and will continue to support medical device incident reports made through the Canadian Medical Devices Sentinel Network (CMDSNet). Furthermore, Vanessa’s Law allows Health Canada to compel manufacturers to conduct assessments, tests, and studies; or, the Department may require manufacturers to reassess their product after a study or a warning from another agency, and then report back to Health Canada.
Health Canada is moving towards a framework which allows for the use of real-world evidence regarding the safety and effectiveness of a product. In this new approach for Health Canada regarding inspection and enforcement, they have signaled that they have more inspectors ready to conduct onsite foreign investigations and other compliance investigations. Manufacturers can expect and increase in the frequency of inspections and compliance verifications.
3. Provide more information to Canadians about the medical devices they use
The Department aims to improve access to medical device clinical data (making it available for independent analysis) – possibly by no longer requiring an Access to Information request. The Department will launch an accessible database with medical device incident reports in a searchable format, and will also provide detailed information on inspections and regulatory actions. Plus, Health Canada will now publish summaries of license application decisions for all new Class IV and Class III medical devices, increasing the number of released summaries from 100 to 1,000+ per year.
Health Canada’s Action Plan shows an overall commitment to improving the safety of medical devices and openness regarding the regulatory process. We recently posted news on Health Canada Cybersecurity Draft Guidance