Medical Device Regulation In Canada: A Primer

Medical devices are monitored through annual licence renewals.

Image courtesy of Health Canada.

Medical devices are
used in the diagnosis,
treatment, mitigation or
prevention of a medical
condition. They include a
vast range of equipment,
from a simple
thermometer or tongue
depressor to highly
sophisticated magnetic
resonance imaging (MRI)
machines or robotically
assisted surgical
equipment.

In Canada, medical devices are regulated by Health Canada’s Therapeutic Products Directorate and are subject to the Medical Devices Regulations under the Food and Drugs Act.

The goal of the Medical Devices Regulations is to ensure, to the extent possible, that devices offered for sale in Canada are safe, effective, and meet quality standards.

Device Licensing

Most medical devices must have a licence before they can be sold in Canada. Health Canada categorizes devices as Class I, II, III, or IV, based on the risks associated with their use, including the degree of invasiveness, duration of contact with the patient, energy transmission hazard, and consequences of device malfunction or failure.

Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential for risk and are subject to in-depth regulatory scrutiny before licensing and sale. The cost-effectiveness of medical devices is not considered. Surgical procedures do not require Health Canada licensing.

In vitro Diagnostic Devices

In vitro diagnostic devices (IVDDs) include reagents, assays and equipment used for examining specimens taken from the body. IVDDs are regulated with a separate classification system, but are also designated as Class I, II, III and IV, based on the degree of risk associated with their use. For example, a blood test that detects bacterial meningitis is categorized as a Class III IVDD because of the risk that a false-negative test result may cause death or long-term disability due to delayed diagnosis. Class IV IVDDs include donor screening tests for transmissible viruses such as HIV and hepatitis, which present a high public health risk. 

Quality Requirements

The Medical Devices Regulations require Class II medical devices to be manufactured under a quality standard (ISO standard 13488:2003) developed by the International Organization for Standardization. Class III and IV devices must meet ISO standard 13485:2003, which deals with both design and manufacturing standards.

Application Process

The Medical Devices Regulations are supplemented by guidance documents, which outline the safety and effectiveness data required for each class of medical device. Licence applications are reviewed by Health Canada staff and licences are issued once all requirements are met. Manufacturers may appeal a decision if licensing is refused, or re-submit applications if additional information is required.

Modifications

Manufacturers frequently make small changes to their devices. Licence amendments are required if significant changes are made to Class III or IV devices, and manufacturers must provide objective evidence of device safety and effectiveness.

Investigational Testing in Human Clinical Trials

Manufacturers or importers may submit a clinical trial application to use unapproved Class II, III, and IV devices in clinical trials provided that:

• the life, health or safety of patients, users or other persons is not seriously endangered

• it is not contrary to the best interests of the patients recruited to the trial

• the objective of the testing will be achieved.

Formal authorization is not required to use a Class I device in a clinical trial, although full trial records must be retained. Devices must be labelled “for investigational use only” and any serious adverse events must be reported to Health Canada within 72 hours.

Trial sponsors must identify all investigators and clinical trial sites and must comply with Research Ethics Board requirements, including protocol approval and informed patient consent. In making their final decision on the application, Health Canada reviewers evaluate the study protocol and design, the hypotheses, the validity of the endpoints and statistical methods, as well as the documentation and management of the trial.

The Special Access Program

This program allows health care professionals to apply for authorization to use medical devices that are not yet licensed in Canada for emergency use, or if conventional therapies have failed, are unavailable or unsuitable. Therapeutic Products Directorate staff review each individual application to assess whether potential risks of using the device outweigh potential benefits.

Harmonization of Regulation with Other Countries

In July 1998, a new regulatory framework was implemented that brought Canada’s regulatory requirements closer to those of the US, the European Union, Japan, and Australia. This framework will undergo continual modification and fine-tuning to appropriately regulate new and emerging medical devices.

More information on regulations for Canadian medical devices is available at: http://www.hc-sc.gc.ca/dhp-mps/md-im/index_e.html