Health Canada plans to allow public release of some clinical information submitted by manufacturers to support applications for regulatory approval of medical devices.
The agency currently treats clinical data as confidential business information and only releases it if needed to protect public health or safety.
Under the new policy, Health Canada would make certain clinical information publicly available for non-commercial purposes following final device approvals. That would include summaries of all completed clinical studies for Class III and Class IV devices, as well as detailed information of all clinical studies for Class IV devices. Class I and II devices would not be subject to these disclosure requirements.
Clinical information provided in medical device applications would continue to be treated as confidential during the regulatory review process. In addition, certain categories of commercial information would be exempted from public release, and medical device manufacturers would be allowed to suggest exemptions in specific cases. Information that identified clinical trial participants would be removed.