In 2014 the Canadian federal government passed Bill C-17, known as Vanessa’s Law, amending the Food and Drugs Act and increasing Health Canada’s powers to obtain information related to the safety of therapeutic products1. On December 23, 2020, additional amendments to the Food and Drug Regulations and Medical Devices Regulations were published in Canada Gazette, Part II, which once in force, will further implement the reporting and transparency measures contemplated by Vanessa’s Law2.
What you need to know
- Post-market surveillance for medical devices: Amendments to the Medical Devices Regulations (MDR) are being made to impose additional post-market reporting requirements for Class II, III and IV medical devices.
- Medical device license holders and importers will be required to proactively report certain foreign risk communications and actions to Health Canada.
- Medical device license holders will also be required to create and retain summary reports which address adverse effects, corrective actions, complaints and incidents.
- Health Canada’s power to order assessments, studies and tests: Amendments to the MDR and Food and Drug Regulations (FDR) clarify the conditions under which Health Canada can order license holders to conduct and provide the results of assessments, studies and tests related to the safety and efficacy of a medical device or drug, pursuant to sections 21.31 and 21.32 of the Food and Drugs Act.
- Prior to these amendments, these order powers were only being used for drugs. Once in force, the amendments will also permit Health Canada to gather additional information where concerns regarding the safety profile or efficacy of a medical device arise following the device’s approval.
- Timing. The medical device summary reporting requirements will come into force on December 23, 2021. The remaining amendments to the FDR and the MDR come into force on June 23, 2021.
- Medical device manufacturers and importers should begin reviewing and updating their internal procedures to ensure they are prepared for the reporting requirements.
Medical device post-market surveillance
Medical device manufacturers and importers currently have mandatory problem reporting obligations under the MDR. These amendments clarify the existing requirements and introduce new provisions to increase Health Canada’s post-market oversight of medical devices.
Reporting foreign regulatory actions
For Class I devices, manufacturers and importers will continue to be subject to the existing reporting threshold for reporting of foreign incidents involving a device sold in Canada to Health Canada. However, medical device license holders and importers of higher risk Class II, III and IV devices will be subject to elevated reporting standards for certain foreign regulatory risk actions. Specifically, the amendments to the MDR will require such parties to file a report with Health Canada when they or a designated foreign regulatory agency, take any of the following actions in specified foreign jurisdictions with respect to a serious risk related to a Class II, III or IV device on the market in Canada: i) communications regarding risks related to the device; ii) changes to the labelling of the device; iii) recalls; and iv) reassessments, suspensions or revocations of device authorizations3. Reports must be made to Health Canada within 72 hours of receiving or becoming aware of the relevant information.
The list of designated foreign regulatory agencies currently specifies 39 jurisdictions including regulatory agencies in Australia, China, numerous European countries, Japan, Mexico, Singapore, South Korea, Russia, United Kingdom and the United States4.
Annual and biennial summary reports
Medical device license holders will also be required to prepare and retain summary reports which address adverse effects, complaints, reportable incidents and reportable foreign regulatory communications and actions, associated with a device over the reporting period. Each summary report must also address whether or not the benefits or risks associated with the medical device have changed over the reporting period. If, in the course of preparing the report, the license holder concludes that there has been a change in the safety and efficacy of the device, Health Canada must be notified of such a conclusion within 72 hours.
For Class II devices, these reports must be prepared every 24 months, while reports for Class III and IV devices will need to be prepared every year. These summary reports do not have to be proactively submitted to Health Canada, but Health Canada can request the reports and supporting information at any time. The reports and supporting information will be subject to a seven-year retention period.
Health Canada’s order powers
Vanessa’s Law gave Health Canada the power to order manufacturers of drugs and devices to conduct assessments, tests and studies related to their products, and to provide the results to Health Canada. The amendments to the FDR and MDR provide some clarification on the scope of Health Canada’s powers with respect to these orders.
While there are specific conditions that must be met for each particular order, generally Health Canada must have reasonable grounds to believe that the benefits or risks associated with the drug or device are significantly different than when the product was authorized to use its power to order further studies. Where Health Canada orders an assessment under section 21.31 of the Food and Drugs Act, if the regulated party does not comply with the order or complies, but in a manner deemed insufficient by Health Canada, Health Canada may suspend or cancel the associated licence (e.g., medical device licence, drug identification number).
While there are a few months before the new medical device reporting obligations will come into effect, medical device manufacturers and importers should begin reviewing and updating their internal procedures to ensure they are prepared for the reporting requirements. Particularly, medical device license holders and importers will need to implement internal systems to monitor for the applicable reportable foreign risk information to ensure that it is reported to Health Canada on a timely basis. This will require coordination with other jurisdictions where the devices are sold. Procedures for preparing the biennial and annual summary reports will also need to be developed in due course, and updates to company retention policies may be needed in view of the seven-year record obligation.
1 For more information on the initial introduction of Vanessa’s Law, see Torys’ prior bulletin: https://www.torys.com/pages/fdl/top-10-series-regulation-of-drugs-and-devices-in-canada/canadian-food-and-drug-law-amendments-50-years-in-the-making
2 Canada Gazette, Part II, Volume 154, Number 26, Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262: http://www.gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html?wbdisable=false
4 See the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/list.html
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