Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices Regulations (CMDR). The amendments under these regulations strengthen Health Canada’s ability to collect post-market safety information in support of Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act) by providing the authorities with more power to regulate medical devices.1
Currently, product license holders under Health Canada are not required to provide detailed post-market reports, which sometimes leads to a delayed evaluation of medical devices. However, under this amendment, if Health Canada has any reasons to believe that the product poses a serious risk to public health, the license holder may be ordered to submit all the information which is in their possession. The authorities may also disclose confidential business information without notifying the license holder if such disclosure will protect public health.1
Similar to the EU MDR, Health Canada is also beginning to implement the submission of ‘Summary Reports’. Product license holders will be required to submit summary reports on a biennial basis for class II devices and an annual basis for class III and class IV medical devices. When the proposed rule first came out, industry stakeholders expressed concerns about the additional burden on class II device license holders to submit summary reports annually, and thus the requirement for class II devices was reduced from annual report submissions to biennial reports.1 These summary reports include the adverse effects, serious risks of injury to human health that are relevant to the safety of the medical device, and a critical analysis of the information presented in the report.1
The amendment also clarifies that foreign risk notifications must be provided to Health Canada for class II, III, or IV medical devices within the stipulated 72-hour timeline only, thus declining the industry’s request for a 10-day timeline to provide such notifications.1 With this step, Health Canada is trying to incorporate some of the European requirements into its regulations and it will be interesting to see how the industry digests and implements these new requirements.
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1Health Canada (Dec 2020) Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262 retrieved on 1/18/2021 from http://www.gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html