Medical Device Clinical Trials Health Canada

However there are regulations governing investigational testing of medical devices.

Medical device clinical trials health canada.

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

Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada. A trial provides information about the risks and benefits of a medical device. Division of cardiovascular devices. Clinical trials for medical devices.

Clinicaltrials gov and current controlled. However information about these trials is not contained within the database at this time. Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Is not yet available in canada.

Health canada also authorizes trials involving natural health products and devices. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. 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. 1 clinical trials for medical devices are predominantly conducted to identify the safety and performance of.

Please contact us at. Fda and the ide process owen faris ph d. The regulations governing medical devices are within the canadian food and drugs act. These trials are authorized by health canada and are conducted on a device that.

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. If you wish to submit an application for authorization of a clinical trial under the io please contact health canada. Office of device evaluation. May be used for another purpose or.

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.