Medical Device Clinical Trials Canada

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 clinical trials canada.

Last march amendments to canada s food and drug regulations and the medical devices regulations enabled the public release of clinical information submitted to health canada for new drug and device approvals. 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. 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.

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. 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. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. This is a limited clinical investigation of a device early in development typically before the device design has been finalised for a specific use.

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. However information about these trials is not contained within the database at this time. What are the types of clinical trials involving medical devices.

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. The main types of clinical investigations for medical devices are outlined below. Pons is an investigational device and currently under review for market clearance by an eu notified body and by tga. Division of cardiovascular devices.

Health canada also authorizes trials involving natural health products and devices. If you wish to submit an application for authorization of a clinical trial under the io please contact health canada. Clinical trials for medical devices. Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada.

Trials using pharmaceutical drugs.