Clinical trials involving medical devices are not regulated by Health Canada; however there are regulations governing investigational testing of medical devices.
Canadian regulations
The regulations governing medical devices are within the Canadian Food and Drugs Act.
The manufacturer of a medical device:
- must ensure that the medical device meets the safety and effectiveness requirements laid out in the Medical Devices Regulations
- must keep objective evidence to establish that the medical device meets those requirements
Medical device classes
Medical devices are classified into one of Classes I to IV. The classification is based on the level of invasiveness and whether the device is active (i.e., depends on a source of energy for operation, a source other than the energy generated by the human body or gravity).
Class I represents the lowest risk medical devices while Class IV represents the highest risk. If a medical device can be classified into more than one class, the class representing the highest risk applies.
Health Canada officially classifies all investigational medical devices. The medical device class designation letter from Health Canada must be submitted with the application for investigational testing of the device with humans.
Investigational testing authorization (ITA)
Human experimentation and development of medical devices are not always established by phased development as with drugs (i.e., Phase I - IV clinical trials).
Proposed medical device research with humans is evaluated through the Device Evaluation Division of the Medical Devices Bureau of Health Canada.
An application is submitted and evaluated according to the Investigational Testing Authorization program governing the use of Class II, III, and IV medical devices. Class I medical devices do not require investigational testing authorization.
If the investigational testing of a device is in conjunction with a drug in a clinical trial then the sponsor must obtain authorization for the clinical trial and authorization for the use of the investigational medical device.
Following a favourable Health Canada review of the Application for Investigational Testing a "No Objection Letter" (NOL) is sent to the Manufacturer/Sponsor indicating Health Canada's agreement for the Manufacturer/Sponsor to conduct the research.
Health Canada requires notification of ethics clearance for the study through a Research Ethics Board prior to issuing a No Objection Letter. This is the Clinical Research Ethics Board (CREB) at the University of Waterloo.
The CREC can provide to the investigator certification of conditional ethics clearance for the study when the absence of ethics clearance is the only element preventing Health Canada from issuing a No Objection Letter. The study may not be initiated until the Office of Research Ethics receives the No Objection Letter from the Investigator via the sponsor.