Regulatory innovation for health products: Agile licensing for medical devices
On this page
- Current state of regulatory process for licensing medical devices
- Our plan
- Implications from COVID-19
- Opportunities for comment
- Contact us
Current state of regulatory process for licensing medical devices
Medical devices in Canada are regulated through the Medical Devices Regulations. The pace of innovation today means that medical devices are evolving more rapidly than the traditional regulatory frameworks that were designed to regulate them. There has also been a shift among international regulators toward greater post-market oversight for medical devices.
In response to these trends, Health Canada has been introducing legislative and regulatory amendments over time. We have also been implementing certain practices through policy.
In 2018, we initiated the Medical Devices Action Plan. This action plan focused on:
- improving how medical devices get to market
- strengthening monitoring and follow up for devices already in use
- providing Canadians with more information about the medical devices they rely on
We are continuing to enhance our oversight of medical devices to support patients, industry and the health care system.
This proposal builds on progress made through the action plan to optimize medical device oversight. It will provide greater regulatory agility by:
- re-examining the way we classify lower-risk devices, to ensure we regulate in proportion to the level of risk
- leveraging real-world evidence on a product's risks and benefits as information emerges post-market
- enabling an adaptive and modern licensing scheme with more tools, such as terms and conditions, to effectively oversee devices across their lifecycle
- improving patient access to devices unavailable in Canada by allowing the use of decisions made by trusted foreign regulators in certain circumstances
- providing enhanced information to Canadians about their medical devices (for example, by improving patient-specific labelling, particularly for high-risk implantable devices)
With emerging and complex medical device technologies, our plan will ensure more appropriate and risk-based oversight of devices while better enabling innovation.
Implications from COVID-19
In March 2020, Health Canada introduced the first interim order for the importation and sale of medical devices to respond to urgent demand during COVID-19. This temporary measure provided more agility to expedite the approval of medical devices for COVID-19.
- expand the use of terms and conditions on approvals
- use the decision of a trusted foreign regulatory authority in certain circumstances
We will continue to assess needs and adapt to emerging priority areas related to COVID-19. Our experience responding to the pandemic will inform this work moving forward.
Opportunities for comment
In 2021, Health Canada held a first consultation on the proposal to introduce a unique device identification (UDI) system for medical devices in Canada. We also interviewed stakeholders in winter 2022 to further understand the impacts and costs of implementing a UDI system.
We notified stakeholders on our intent to amend the Food and Drug Regulations and Medical Devices Regulations to enhance our regulatory agility. We published a notice of intent in Canada Gazette, Part I in 2021.
Building on the feedback received, we consulted on proposed amendments to this set of regulations. This consultation was open from December 17, 2022, to April 26, 2023. The consultation included proposed regulations as well as a guidance document for comment.
Medical Devices Directorate
Health Products and Food Branch
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