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
- Upcoming opportunities for comment
- Contact us
Current state of regulatory process for licensing medical devices
Health Canada's Medical Devices Regulations regulate traditional devices effectively. New technologies, such as software as a medical device, need more flexibility in our regulatory oversight.
In 2018, we initiated the Medical Device Action Plan (MDAP). This 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 will keep making improvements to our oversight of medical devices to support patients, industry and the health care system.
This proposal builds on progress made through the MDAP to enhance oversight of devices. It will enhance our regulatory agility by:
- re-examining the way we classify lower-risk devices, to ensure we regulate proportionally to risk
- leveraging real-world evidence on a product's risks and benefits as information emerges in the post-market experience
- enabling an adaptive and modern licensing scheme with more tools to effectively oversee devices across their lifecycle (for example, terms and conditions)
- 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)
Our plan will ensure more appropriate and risk-based oversight of devices while better enabling innovation.
Implications from COVID-19
We introduced an interim order for the importation and sale of medical devices to respond to urgent demand during COVID-19. This temporary measure provides more agility to expedite the approval of medical devices for COVID-19.
The interim order includes some of the elements planned for the agile licensing initiative, such as the ability to:
- apply 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. We are also using our experience with COVID-19 to help us develop our regulatory proposals.
Upcoming opportunities for comment
We are currently engaging with stakeholders on 2 proposals:
- Please read the Proposal to introduce a unique device identification (UDI) system for medical devices in Canada and respond to the questions for stakeholders.
- For the first phase of the Agile Licensing for Drugs proposal, Health Canada is launching a consultation on the proposed targeted amendments to the Food and Drug Regulations and Medical Devices Regulations. To find out more, please see the Canada Gazette, Part I publication. Stakeholders can comment on this regulatory proposal until October 28, 2021.
Medical Devices Directorate
Health Products and Food Branch
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