Medical Device Clinical Trials Canada

Health canada also authorizes trials involving natural health products and devices.

Medical device clinical trials canada.

However information about these trials is not contained within the database at this time. Division of cardiovascular devices. If you wish to submit an application for authorization of a clinical trial under the io please contact health canada. Class iv medical devices e g a pacemaker pose the highest risk.

This is a limited clinical investigation of a device early in development typically before the device design has been finalised for a specific use. Ethical conduct for research involving humans 2010 and conform to good clinical practices gcp as set out by iso 14155 clinical investigation of medical devices for human subjects. In canada medical devices are grouped into 4 classes based on the expected level of risk to a person s health and safety. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages.

Office of device evaluation. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. Human experimentation and development of medical devices are not always established by phased development as with drugs i e phase i iv clinical trials. What are the types of clinical trials involving medical devices.

Please contact us at. Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. How medical devices are licensed and regulated licensing of medical devices. The procedure for recalling a covid 19 medical device used in a clinical trial follows the same instructions that are outlined in the guide to recall of medical devices gui 0054.

Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada. For medical devices the sequence is fairly similar and some devices do go through a clinical trial phase process however most medical devices will go through clinical trial stages instead of phases. Clinical trials investigational tests are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. Clinical trials for medical devices.

Proposed medical device research with humans is evaluated through the device evaluation division of the medical devices bureau of health canada. Trials using pharmaceutical drugs. Fda and the ide process owen faris ph d. Clinical trials conducted with natural health products and medical devices.