Health Canada has released a notice to inform manufacturers and importers of medical devices of their intent to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada.
The proposal is part of the project entitled “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.
Reasons for changes to be made to the Medical Device Regulations include, an increase in the complexity of medical devices and a push for greater alignment of regulations with those of other countries.
Health Canada intends to propose the following changes to the Medical Device Regulations:
Analytical issue reports
- Provide the Minister of Health 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.
- 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.
To read more on the notice of intent from Health Canada regarding the strengthening of post-market surveillance and risk management of medical devices, please click here.