Under the Food and Drugs Act, Health Canada defines a device as "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in
- diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- storing, correcting or modifying a body function or the body structure of human beings or animals;
- the diagnosis of pregnancy in human beings or animals, or
- the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring;
and includes a contraceptive device but does not include a drug.
The Medical Devices Regulations were published in the Canada Gazette Part II, May 1998 and came into force July 1, 1998. The Regulations replace the old Medical Devices Regulations that were in existence since 1978.
The new Regulations require the manufacturer of a medical device to satisfy 11 safety and effectiveness requirements based on objective evidence to establish that a medical device satisfies those requirements. In addition, a medical device must bear a label that contains specific information as described in the Regulations.
Regulating medical devices in Canada is the responsibility of the Therapeutic Products Programme at Health Canada. The TPP comprises several bureaus that regulate pharmaceuticals, blood, biologic's, disinfectants and medical devices. Medical devices fall within the domain of the Medical Devices Bureau.
The Bureau is responsible for processing device license applications, reviewing the safety and effectiveness data for various devices, establishing standards and policies for medical devices as well as addressing related issues regarding the safety of medical devices. The TPP web site contains documents that may be downloaded including the Medical Devices Regulations, Guidance Documents, Policy Documents, Information Letters, Alerts, and other information for manufacturers to keep abreast of regulatory requirements.
Under the new Medical Devices Regulations, medical devices are classified into one of four classes based on their risk to the patient. The four risk classes, numbered I, II, III and IV, represent varying degrees of risk; I being the lowest and IV the highest. Determination of risk class is based on a set of rules contained within the regulations. Each rule defines how a device is classified based on how it is used, whether it is invasive, what system of the body it primarily effects and whether energy, either electrical or other, may be transferred in a potentially hazardous way.
Because of this system of rules, it is referred to as a ruled based set of regulations and a Risk Based Classification System. In-vitro diagnostic devices are classified separately from medical devices but are nevertheless classified into one of four risk classes. Medical devices may be arranged into families, groups, group families or systems for purposes of obtaining a medical device license.
The manufacturer of a Class II, III or IV medical device must obtain a device license before the product may be sold on the Canadian market. The requirements for obtaining a device license vary according to the risk classification of the device. The exception is for Class I devices, which do not require a license, although they are still subject to the safety and effectiveness requirements of the Regulations. Class II device license applications are fairly straightforward and require basic information. Class III and IV applications are more involved and require the submission of more substantial information to support the safety and effectiveness requirements.
For regulatory affairs inquiries, please submit your query here.
For more information on the regulations affecting medical devices, you may refer to:
Medical Devices Bureau
Therapeutic Products Programme
Health Canada
Main Statistics Canada Bldg.
Tunney's Pasture
Ottawa, Ontario KlA OL2
Canada
Tel: 1-800-267-9675
Website: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html
