Medical Device Clinical Trials Canada

This is a limited clinical investigation of a device early in development typically before the device design has been finalised for a specific use.

Medical device clinical trials canada.

Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. However information about these trials is not contained within the database at this time. Please contact us at. Pons is now authorized and commercially available in canada for the acute treatment of chronic balance deficit due to mild to moderate traumatic brain injury mmtbi and is used in conjunction with physical therapy pt.

The main types of clinical investigations for medical devices are outlined below. 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. 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.

Trials using pharmaceutical drugs. Fda and the ide process owen faris ph d. The international medical device regulators forum imdrf seeks to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety effectiveness. If you wish to submit an application for authorization of a clinical trial under the io please contact health canada.

Clinical trials investigational tests are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. Office of device evaluation. Clinical trials conducted with natural health products and medical devices. The medical devices regulations provide a mechanism to authorize the sale or importation of devices to be used for the purposes of clinical trials involving human subjects.

But in the first five months after the amendments took effect just one clinical trial package for a new drug and one clinical trial package for a new device were published. What are the types of clinical trials involving medical 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. Pons is an investigational device and currently under review for market clearance by an eu notified body and by tga.

Clinical trials for medical devices.