Clinical trials for medical devices
Clinical trials, or investigational testing, are tests done to look at the safety and effectiveness of a medical device in humans.
Most requested
Guidance on clinical trials
Applications for medical device investigational testing authorizations
Guidance on how to prepare an application to conduct investigational testing of a Class II, III or IV medical device
Applications for investigational testing, in vitro diagnostics devices
Guidance on how to prepare an application to conduct investigational testing of a Class II, III or IV in vitro diagnostic medical device
Changes to timing of Research Ethics Board approval for applications for medical device testing authorizations
Notice about investigational testing of medical devices and obtaining REB approval
Medical devices for COVID-19: Conducting a clinical trial
Guidance to manufacturers of medical devices on how to apply for a clinical trial to treat COVID-19
Guidance on the registration of clinical trials and public disclosure of results
Where and how to register a clinical trial, report results and find information on the Canadian clinical trial search portal
Guidance documents for medical devices
Guidelines on how to interpret policies, legislation and regulations
Resources
Release of information about medical device investigational testing applications
Health Canada notice on releasing certain information about clinical trials involving the use of medical devices in humans
Notices and announcements about medical devices
List of current and past announcements, including consultations and guidance documents on medical devices
Clinical information on new medical devices
Clinical information about new medical devices to assess safety and efficacy, making information available after regulatory reviews
Modernizing clinical trial regulations
Our plan to improve access to novel therapies by modernizing the regulations for clinical trials