Recently published amendments to Canada’s Medical Devices Regulations, which will take effect in June and December of 2021, impose additional post-market surveillance and reporting obligations on holders of medical device licences and medical device establishment licences (“MDELs”).
The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, aims to improve patient safety, in part by granting Health Canada greater monitoring authority over the lifecycle of therapeutic products including drugs and medical devices.
Since it received royal assent in 2014, regulations under Vanessa’s Law have been implemented in phases and Health Canada has released accompanying guidance documents, which we tracked in our earlier bulletin, "Health Canada To Publish Regulations Implementing New Authorities under Vanessa’s Law".
Amendments to the Medical Devices Regulations
Most recently, Health Canada announced its intention to implement additional powers included in Vanessa’s Law by way of amendments to the Medical Devices Regulations. These amendments, published in the Canada Gazette on December 23, 2020, will increase post-market surveillance and reporting in respect of medical devices.
The amendments to the Medical Devices Regulations, which will come into force on June 23, 2021 and December 23, 2021 (as indicated below), will add to existing post-market obligations in several ways:
Notification of Foreign Regulatory Action in Response to Serious Risks of Injury (June 23, 2021):
- Holders of device licences and MDELs authorizing import of Class II, III, or IV devices will be required to submit information to Health Canada in respect of any serious risk of injury that is relevant to the safety of a device within 72 hours of receiving or becoming aware of it.
- The submitted information must include risks communicated by certain foreign regulatory agencies, changes to the device labelling requested by such foreign regulatory agencies, and recalls, reassessments, and suspensions or revocations of device authorizations within the jurisdiction of such foreign regulatory agencies.
- Health Canada has indicated that this information will be submitted using an electronic form which it will make available on its website in the coming months.
- All device manufacturers and importers will continue to be required to submit preliminary and final reports to Health Canada concerning incidents occurring in Canada (and, in the case of Class I devices only, outside Canada) relating to a failure of a device, a deterioration in its effectiveness, or any inadequacy in its labelling or directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur.
Orders to Conduct Assessments, Compile Information, Conduct Tests or Studies, and Monitor Experience (June 23, 2021):
- If Health Canada has reasonable grounds to believe the benefits or risks associated with a device are significantly different than they were when the device licence was issued or amended, it will be empowered to order the device licence holder to conduct an assessment of the device and provide the results.
- If Health Canada has reasonable grounds to believe there are significant uncertainties relating to the benefits or adverse effects associated with a device, the licensee is unable to provide information sufficient to manage such uncertainties, and such information cannot otherwise be obtained, Health Canada will be empowered to order the device licence holder to compile information, conduct tests or studies, or monitor experience in respect of the device and provide the results.
Issue-Related Analyses of Safety and Effectiveness (June 23, 2021):
- If Health Canada has reasonable grounds to believe that a device may not meet applicable safety and effectiveness requirements, it may request the manufacturer to submit an analysis or other information to enable a determination as to whether the device meets those requirements.
Summary Reports (December 23, 2021):
- Certain device licence holders will be required to prepare summary reports pertaining to adverse effects, reported problems relating to the performance characteristics or safety of a device, and incidents in Canada relating to a failure of a device, a deterioration in its effectiveness, or any inadequacy in its labelling or directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur.
- The report must include a concise critical analysis of the adverse effect, problem, or incident (as applicable) and conclusions as to whether the benefits and risks associated with the device have changed (e.g., lessening of benefits, increase in known risks, or identification of new risks). Holders of Class II device licences must prepare the report on a biennial basis covering matters the licensee received or became aware of during the previous 24 months; holders of Class III or IV device licences must prepare the report annually and cover the previous 12 months. Device licence holders must maintain records of the summary reports and the underlying information for seven years. Health Canada may request submission of the reports or the underlying information to determine whether the device meets applicable safety and effectiveness requirements; however, a licence holder must notify Health Canada within 72 hours of reaching any conclusion that the benefits and risks associated with the device have changed.
Health Canada published a draft guidance document covering some of these changes in June 2019. Health Canada has indicated that four final guidance documents to support compliance with these changes will be published shortly on its website, and that it will be hosting virtual information sessions to present the new regulations and the associated guidance documents.
Holders of device licences and MDELs should consider how the upcoming changes to the Medical Devices Regulations will affect their post-market obligations and concomitant changes to internal processes and procedures. Fasken’s life sciences team has significant experience in the regulation of medical devices and other therapeutic products and would be pleased to consult and advise on the changes.