Medical Device Clinical Trials Canada

Manufacturers should proactively notify health canada if they become aware of the need to recall a covid 19 medical device in canada.

Medical device clinical trials canada.

Please contact us at. 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 s expectation is that manufacturers follow the principles of the declaration of helsinki and the tri council policy statement 2nd edition. Trials using pharmaceutical drugs.

The main types of clinical investigations for medical devices are outlined below. 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. You can also refer to the guidance document for covid 19 drug clinical trials or for covid 19 medical device clinical trials. 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. Human experimentation and development of medical devices are not always established by phased development as with drugs i e phase i iv clinical trials. Clinical trials investigational tests are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. Division of cardiovascular devices.

Class i medical devices e g a thermometer pose the lowest risk to users. Clinical trials conducted with natural health products and medical devices. However information about these trials is not contained within the database at this time. 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. What are the types of clinical trials involving medical devices. Fda and the ide process owen faris ph d. Proposed medical device research with humans is evaluated through the device evaluation division of the medical devices bureau of health canada.

In canada medical devices are grouped into 4 classes based on the expected level of risk to a person s health and safety. Clinical trials for medical devices. This is a limited clinical investigation of a device early in development typically before the device design has been finalised for a specific use. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages.