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As defined in the Food and Drugs Act (the "Act"), administered by Health Canada, a "device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in
As defined in the Medical Devices Regulations:
Software, either stand alone sold for the purposes given in the definition of a device (Patient Management Software) or used as a component to a device, is included in the term "medical device".
For more definitions, visit Medical Devices Regulations
The Medical Devices Regulations MDRs use this definition of a Medical Device without the reference to animals.
The MDRs were published in the Canada Gazette Part II, May 1998 and came into force July 1, 1998. The Regulations replaced the old Medical Devices Regulations that were in existence since 1978.
The MDRs require the manufacturer of a medical device to satisfy 11 safety and effectiveness requirements based on objective evidence to be provided to the authorities. 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 Program at Health Canada. The TPP comprises several bureaus that regulate pharmaceuticals, natural health products, blood products, biologic's, disinfectants and medical devices. Medical devices fall within the domain of the Medical Devices Bureau MDB.
The MDB is responsible for processing device license applications upon the review of safety and effectiveness data and establishing standards and policies for medical devices as well as addressing related issues regarding the safety of medical devices. The Health Canada website contains documents that may be downloaded including the Medical Devices Regulations, Guidance Documents, Policy Documents, Information Letters, and Alerts etc. for manufacturers to keep abreast of regulatory requirements.
Under the MDRs, medical devices are classified into one of four classes, numbered I, II, III and IV, based on their risk to the patient; 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 the classification based on how it is used, whether it is invasive, what system of the body it primarily affects, and whether energy, either electrical or other, may be used and/or 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 have their own rules for classification into one of four risk classes but follow the same principles. 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 such a license vary according to the risk classification of the device. Class II device license applications are fairly straight forward and require only basic information. Class III and IV applications are more involved and require the submission of substantial information to support the claims that safety and effectiveness requirements are met.
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.
For regulatory affairs inquiries, please submit your query here.
Medical Devices Bureau
Phone: (613) 957-7285