Health Canada announced their plans to propose changes to strengthen the post-market surveillance and risk management of medical devices in Canada. This is part of the 5-year initiative on Health Canada’s regulatory review of drugs and devices as well as keeping in line with the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
Health Canada has stated their reasons to make changes to the Medical Devices Regulations which includes:
- increasing the complexity of medical devices,
- increase the use of real-world data and evidence amongst international regulators,
- push for greater alignment of regulations with those of other countries; as well as
- produce an environment that supports the integration of new technologies into the health care system while maintaining patient safety.
The overall objective to strengthen the post-market surveillance of medical devices is to provide additional oversight on medical devices already in the market and to ensure these are safe and effective to use.
These changes will allow the Minister of Health the ability to:
- Request analytical issue reports from a manufacturer when there is a suspicion or concern of safety with a medical device
- Request the information that was used to create the analytical issue report and any other information in the manufacturer’s possession
- Require manufacturers to prepare annual reports
- Require manufacturers to notify Health Canada of any significant changes to he safety of the medical device as brought up from the report
- Request the information used to prepare the reports
There will also be proposed changes that will apply specifically to Class II, III and IV medical devices. This will cause manufacturers to provide to Health Canada any risk communications, changes to labelling, recalls, reassessments, suspensions or revocations of medical devices occurring in other countries.
The proposed regulations will be published sometime in 2019 where it will be available for comments or questions by the public.
For more information, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian regulatory consultants for Medical Devices and other products regulated by Health Canada.