Medical Device Clinical Trials Health Canada

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Medical device clinical trials health canada.

Division of cardiovascular devices. Please contact us at. Clinical trials involving medical devices are not regulated by health canada. These trials are authorized by health canada and are conducted on a device that.

Clinical trials or investigational testing are tests done to look at the safety and effectiveness of a medical device. 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. Clinical trials for medical devices.

Trials using pharmaceutical drugs. Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Clinical trials conducted with natural health products and medical devices. Office of device evaluation.

The regulations governing medical devices are within the canadian food and drugs act. 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 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. 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.

Clinicaltrials gov and current controlled. However there are regulations governing investigational testing of medical devices. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. The manufacturer of a medical device.

However information about these trials is not contained within the database at this time. 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. May be used for another purpose or.

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. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages.