Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada
This Notice of Intent is to inform stakeholders, notably manufacturers and importers of medical devices, of our intent to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada.
This proposal is part of the project, Strengthening the use of real-world evidence and regulations for medical devices, which is part of a 5-year initiative on the regulatory review of drugs and devices.
Drivers for change
There are several reasons to make changes to the Medical Devices Regulations at this time, including:
- an increase in the complexity of medical devices;
- an increase in the generation and use of real-world data and evidence amongst international regulators;
- a push for greater alignment of regulations with those of other countries; and
- a need for an environment that supports the integration of new technologies into the health care system while maintaining patient safety.
Together, these changes will inform the work to strengthen the post-market surveillance of medical devices. Strengthened post-market surveillance of medical devices will provide additional oversight on medical devices already in use to help to ensure they are safe and effective.
Our proposed changes to the Medical Devices Regulations
In 2014, the Protecting Canadians from the Unsafe Drugs Act (Vanessa's Law) introduced changes to the Food and Drugs Act (FDA) to enhance our ability to collect post-market safety information and take appropriate action when a serious risk to health is identified. Regulations are currently needed to bring the life cycle amendments of Vanessa's Law into force for medical devices.
We intend to propose the following changes to the Medical Devices Regulations:
- Analytical issue reports
- Provide the Minister of Health (the Minister) with the authority to request analytical issue reports from a manufacturer (using information in the manufacturer's possession) when there is a suspicion of a safety concern with a medical device and set out the conditions under which the authority would be used.
- Provide the Minister with the authority to request the information that was used to create the analytical issue report and any other information in the manufacturer's possession deemed necessary to assess the safety of a medical device.
- Annual reports
- Provide the Minister with the authority to require manufacturers to prepare annual reports.
- Require manufacturers to notify Health Canada of any significant change in the safety of a medical device arising from the report.
- Provide the Minister with the authority to request the information used to prepare the reports.
We also intend to propose new regulations under the Medical Devices Regulations to support the coming into force of the following lifecycle authorities under the FDA for medical devices:
- The authority to compel manufacturers to conduct a reassessment (section 21.31 of the FDA) and the conditions under which this authority would be used.
- The authority to require tests and studies (section 21.32 of the FDA) and the conditions under which this authority would be used.
- Regulations which require manufacturers to provide notification to Health Canada of any risk communications, changes to labelling, recalls, reassessments, and suspensions, or revocations of medical devices occurring in other countries.
We envision that these changes would apply to Class II, III and IV medical devices.
Future opportunities to comment
We plan to pre-publish the proposed regulations in the Canada Gazette, Part I, in 2019 for comment.
Guidance will also be made available for comment to ensure a fulsome understanding of how the proposed regulations may be applied.
If you wish to provide any comments or have questions related to this Notice, please contact the Marketed Health Products Directorate, Health Products and Food Branch, Health Canada.
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