Notice: Static Magnets Sold as Medical Devices
March 31, 2017
Reference number: 17-103061-812
The purpose of this Notice is to communicate the Therapeutic Products Directorate's (TPD) finalized position regarding static magnets. This notice applies to all magnets intended to apply a non-varying magnetic field to the human body for a therapeutic purpose. It does not apply to static magnets sold as components of a medical imaging system.
Static magnets that meet the definition of a device are classified as Class I devices, as per Rule 7, Schedule 1 Classification Rules of the Medical Devices Regulations.
In the past, small static magnets had been sold with a wide range of medical claims (i.e., increased blood circulation, increased oxygenation, reduction of high blood pressure, stimulation of the immune system, and treatment of sleep disorders), and as such were considered to be medical devices. These magnets were available in a variety of products such as pads, bandages, blankets, mattresses, shoe insoles, and jewellery.
According to Sections 12(1) and 9(2) of the Medical Devices Regulations, a medical device shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented. The manufacturer of the device must also keep objective evidence to substantiate the claims made for the device. A review of the scientific literature by the Medical Devices Bureau has concluded that there is insufficient published evidence to indicate that static magnets are beneficial for therapeutic purposes.
The TPD considers claims for specific therapeutic benefits of static magnets to be unfounded. These claims include, but are not limited to: pain relief, increased blood circulation, increased oxygenation, and reduction of high blood pressure, stimulation of the immune system and the treatment of sleep disorders, infections, depression, erectile dysfunction, rheumatoid disease and cancer. A static magnet promoted for any of these purposes will be deemed to be in violation of either Section 20 of the Food and Drugs Act or Section 12(1) of the Medical Devices Regulations, and may be subject to compliance and enforcement action.
Compliance and enforcement actions under the Medical Devices Regulations are carried out by the Regulatory Operations and Regions Branch (RORB). The RORB may take compliance and enforcement action against static magnets represented for medical benefits. In such cases, RORB's policy on compliance and enforcement will be followed to ensure that decisions are transparent, fair and appropriate to the risk. Action will be taken on a case-by-case basis, taking into consideration the significance of the medical representations being made. Significant representations that are likely to result in regulatory action include, but are not limited to, treatment of cancer, human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), asthma, arthritis, high blood pressure, and rheumatism.
A product that is not manufactured, sold or represented for the treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state or its symptoms, or for restoring, correcting or modifying a body function or structure, is not considered to be a "device" under the Food and Drugs Act, nor a "medical device" under the Medical Devices Regulations. Products that do not fall under the Act or the Regulations may include statements such as the promotion of a sense of general health, vitality and well-being.
Questions or concerns related to this Notice should be directed to the Medical Devices Bureau at email@example.com.
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