Medical Device Clinical Trials Canada

Division of cardiovascular devices.

Medical device clinical trials canada.

Proposed medical device research with humans is evaluated through the device evaluation division of the medical devices bureau of health canada. Class i medical devices e g a thermometer pose the lowest risk to users. However information about these trials is not contained within the database at this time. Trials using pharmaceutical drugs.

This is a limited clinical investigation of a device early in development typically before the device design has been finalised for a specific use. Clinical trials for 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. 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 investigational tests are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. Please contact us at. 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. Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada.

Human experimentation and development of medical devices are not always established by phased development as with drugs i e phase i iv clinical trials. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. Health canada also authorizes trials involving natural health products and devices. Clinical trials conducted with natural health products and medical devices.

Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Fda and the ide process owen faris ph d. What are the types of clinical trials involving medical devices. If you wish to submit an application for authorization of a clinical trial under the io please contact health canada.

Class iv medical devices e g a pacemaker pose the highest risk. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. In canada medical devices are grouped into 4 classes based on the expected level of risk to a person s health and safety. How medical devices are licensed and regulated licensing of medical devices.