Medical Device Clinical Trials Health Canada

Clinicaltrials gov and current controlled.

Medical device clinical trials health canada. 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. Trials using pharmaceutical drugs. Office of device evaluation.

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. The manufacturer of a medical device. Is not yet available in canada. However information about these trials is not contained within the database at this time.

You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. The regulations governing medical devices are within the canadian food and drugs act. May be used for another purpose or. These trials are authorized by health canada and are conducted on a device that.

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. Clinical trials for medical devices. A trial provides information about the risks and benefits of a medical device. Please contact us at.

The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. Clinical trials conducted with natural health products and medical devices. Clinical trials involving medical devices are not regulated by health canada. Clinical trials or investigational testing are tests done to look at the safety and effectiveness of a medical device.

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. However there are regulations governing investigational testing of medical devices. 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. Division of cardiovascular devices.

Health canada also authorizes trials involving natural health products and devices. 1 clinical trials for medical devices are predominantly conducted to identify the safety and performance of.