Medical Device Clinical Trials Health Canada

Clinical trials for medical devices.

Medical device clinical trials health canada. Clinical trials involving medical devices are not regulated by health canada. Health canada also authorizes trials involving natural health products and devices. Is not yet available in canada. Fda and the ide process owen faris ph d.

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. Clinicaltrials gov and current controlled. 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. Office of device evaluation. However information about these trials is not contained within the database at this time. May be used for another purpose or.

Division of cardiovascular devices. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. Trials using pharmaceutical drugs. The manufacturer of a medical device.

1 clinical trials for medical devices are predominantly conducted to identify the safety and performance of. 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 or investigational testing are tests done to look at the safety and effectiveness of a medical device. A trial provides information about the risks and benefits of a medical device.

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. 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. 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.

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.