Change in disclosure approach for Class III medical devices Clinical information: Notice
Health Canada: December 23, 2025
On this page
Our approach is changing
This change applies to Class III medical devices and it relates to amendments to the Medical Devices Regulations, which came into force on February 28, 2019. These regulatory amendments specify that clinical information in medical device licence applications ceases to be confidential business information following a final regulatory decision. Health Canada is then authorized to publicly release this information.
As part of ongoing efforts to reduce administrative burden, Health Canada's Health Products and Food Branch is stopping the proactive Public Release of Clinical Information for Class III medical devices. This responds to the commitment in the Health Canada and the Public Health Agency of Canada's report on red tape reduction - Canada.ca to reduce the scope of Public Release of Clinical Information for medical devices to focus only on key areas of public interest. These changes do not affect our approach to Class IV medical devices at this time.
Learn more:
- Public release of clinical information on drugs and medical devices
- Health Canada and the Public Health Agency of Canada's report on red tape reduction
- Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information): SOR/2019-62
What this new approach means for you
Any proactive disclosure already initiated for medical devices will continue as planned. However, any Class III applications that have not yet been initiated will not undergo the proactive disclosure process. Clinical information will continue to be made available on request for Class III medical devices.
Access the form to request the release of clinical information for medical devices.
Health Canada is committed to transparency, engaging with stakeholders and supporting informed decision-making by health care professionals, patients and interested stakeholders.
If you want more information or have questions about the public release of clinical information, you may email us at clinicaldata-donneescliniques@hc-sc.gc.ca.