Medical Device Clinical Trials Canada

If you wish to submit an application for authorization of a clinical trial under the io please contact health canada.

Medical device clinical trials canada.

Office of device evaluation. What are the types of clinical trials involving medical devices. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. Proposed medical device research with humans is evaluated through the device evaluation division of the medical devices bureau of health canada.

Class iv medical devices e g a pacemaker pose the highest risk. Human experimentation and development of medical devices are not always established by phased development as with drugs i e phase i iv 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. Fda and the ide process owen faris ph d.

Health canada s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Please contact us at. How medical devices are licensed and regulated licensing of medical devices. Clinical trials conducted with natural health products and medical devices.

Class i medical devices e g a thermometer pose the lowest risk to users. 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. In canada medical devices are grouped into 4 classes based on the expected level of risk to a person s health and safety.

Division of cardiovascular devices. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. 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. Clinical trials for 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. Health canada also authorizes trials involving natural health products and devices. Trials using pharmaceutical drugs. The main types of clinical investigations for medical devices are outlined below.