Drug and medical device clinical trial information is now publicly available in Canada
Regulations made under Vanessa’s law target clinical trial information transparency for Canadian drug and medical device approvals.
On March 20, 2019, new regulations relating to clinical trial information transparency were published in the Canada Gazette, part II. There are two parts to the regulations, one part amending the Food and Drug Regulations to deal with the drug approval process, and one part amending the Medical Device Regulations, to address medical device approvals.
(Continue reading…)Health Canada’s Draft Guidance on SaMD shows the medical devices laws need to be updated for digital health
About a year after it convened a Scientific Advisory Panel with respect to Software-as-a-Medical-Device (SaMD), Health Canada has now released a Draft Guidance Document for public comment until March 29, 2019.
(Continue reading…)Health Canada has commenced a public consultation on its Draft Guidance Document for “Pre-market Requirements for Medical Device Cybersecurity.”
With all the recent reports on the hacking of pacemakers, it’s timely that Health Canada confirms that it “considers cybersecurity a component of the medical device’s design and life-cycle that can impact safety and effectiveness.” The Draft Guidance appears to address both IVDD and non-IVDD devices. Interestingly, however, the Draft Guidance focuses on pre-market/pre-license application activities, and explicitly excludes actual post-market activities. Perhaps Health Canada is waiting for changes to the Medical Devices Regulations it announced earlier this year to strengthen post-market surveillance and risk management of devices before releasing another Draft Guidance on such activities.
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