Medical Device Clinical Trials Health Canada

A trial provides information about the risks and benefits of a medical device.

Medical device clinical trials health canada.

1 clinical trials for medical devices are predominantly conducted to identify the safety and performance of. Is not yet available in canada. Clinicaltrials gov and current controlled. Trials using pharmaceutical drugs.

However information about these trials is not contained within the database at this time. Clinical trials or investigational testing are tests done to look at the safety and effectiveness of a medical device. Clinical trials involving medical devices are not regulated by health canada. However there are regulations governing investigational testing of medical devices.

The regulations governing medical devices are within the canadian food and drugs act. In the context of medical devices a clinical trial or a clinical investigation can be defined as any systematic investigation or study on one or more human subjects undertaken to assess the safety or performance of a medical device. Clinical trials for medical devices. Please contact us at.

Office of device evaluation. May be used for another purpose or. Clinical trials conducted with natural health products and medical devices. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials.

Division of cardiovascular devices. 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. These trials are authorized by health canada and are conducted on a device that. Fda and the ide process owen faris ph d.

If you wish to submit an application for authorization of a clinical trial under the io please contact health canada. Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. 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.

Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Medical device study registration health canada encourages manufacturers to register their clinical investigations on a publicly accessible registry which accepts international clinical trial information and which is recognized by the world health organisation who.