On December 23, 2020, the federal government published significant amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR) in Canada Gazette, Part II. These amendments build on Bill C-17, Vanessa’s Law, which was passed in 2014 to improve Health Canada’s ability to obtain post-market safety information for therapeutic products (as previously reported on by the E-TIPS® Newsletter here). The amendments will implement certain powers that were included in Vanessa’s Law and provide Health Canada with additional measures to improve post-market surveillance of medical devices.
New Reporting Obligations for Class II-IV Devices
The amendments impose several new reporting obligations for Class II-IV Devices. Under the amendments, medical device licence holders will be required to complete summary reports on a biennial basis for Class II devices and on an annual basis for Class III and IV devices. Regulated parties must retain these reports for seven years and are required to submit them to Health Canada upon request. Summary reports should address adverse effects, reportable incidents, complaints, and reportable foreign regulatory communications and actions that occurred with the respected device over the reporting period. The reports must also include an analysis on whether the benefits and risks associated with the device have changed during the reporting period. If there has been a change, then the licence holder must notify Health Canada within 72 hours of reaching this conclusion.
The amendments impose additional foreign risk notification requirements for licence holders and importers of Class II-IV devices that are sold on the Canadian market. These requirements not only apply to actions that the parties take in certain foreign jurisdictions, but may also involve actions by designated foreign regulatory agencies. Regulated parties must file a report with Health Canada within 72 hours, with respect to any serious risk of injury to human health that they receive or become aware of and that is relevant to the safety of the device, including:
Further Implementation of Health Canada’s Powers
In addition to reporting obligations, the amendments incorporate provisions into the MDR to support sections 21.31 and 21.32 of Vanessa’s Law. These provisions fully “operationalize” Health Canada’s authority to order Class II-IV medical device licence holders to conduct assessments, collect information, conduct additional tests and studies, and monitor patient experiences. In deciding whether to order these studies, Health Canada will consider whether the benefits or risks of the device have changed significantly since the device was authorized. Regulated parties should also be aware that the amendments will now allow Health Canada to suspend a medical device licence if it is not satisfied with the licensee’s response to an order pursuant to section 21.31.
Coming into Force
The amendments will come into force in two parts, with the medical device summary reporting obligations coming into force on December 23, 2021 and the remaining amendments coming into force on June 23, 2021.
Summary By: Imtiaz Karamat
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