Radiation Emitting Devices Act and Regulations
On this page
- Regulating radiation emitting devices
- Radiation Emitting Devices Act
- Radiation Emitting Devices Regulations
- Health Canada’s role
Regulating radiation emitting devices
The Radiation Emitting Devices Act (REDA) sets requirements for devices that give off radiation. These are known as radiation emitting devices and include devices that give off:
- acoustical radiation, such as:
- sound
- infrasound
- ultrasound
- electromagnetic radiation, such as:
- X-ray
- infrared
- ultraviolet
- microwave
- visible light
- radiofrequency
REDA and the Radiation Emitting Devices Regulations cover the sale, resale, lease, advertisement, and importation of radiation emitting devices. It’s the responsibility of the manufacturer, importer or distributor to ensure their product complies with the applicable requirements set out in REDA and its regulations.
The regulations include specific standards for some devices (prescribed classes). Manufacturers, importers and distributors must comply with these standards when their device falls into one of the prescribed classes.
Some radiation emitting devices are also subject to other applicable acts.
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Radiation Emitting Devices Act
General requirements
Health Canada calls some of the requirements in the Radiation Emitting Devices Act (REDA) general requirements. They include:
- No person can sell, lease or import a radiation emitting device into Canada if it creates a health risk for any of the following reasons:
- the device does not perform according to the performance characteristics claimed for it
- the device does not accomplish its claimed purpose
- the device emits radiation that is not necessary for it to accomplish its claimed purpose
- All representations about radiation emissions from a device (such as labels, packaging or advertising) must not be false, misleading or deceptive.
- A manufacturer or importer who becomes aware that their product no longer complies with REDA must notify the Minister of Health
Exceptions
Some radiation emitting devices don’t need to meet REDA requirements, REDA doesn’t apply to devices subject to:
Other applicable Acts
In some cases, the requirements under other Acts may apply to a radiation-emitting device. For example:
- Radiation emitting consumer products must meet the requirements of the Canada Consumer Product Safety Act.
- Medical devices must meet the requirements of the Medical Devices Regulations under the Food and Drugs Act.
- The Pest Control Products Act applies to the regulation of products used for pest control, some of which emit radiation.
- The Radiocommunication Act governs the licensing and regulation of radio equipment, including radiation emitting devices, such as:
- cell towers
- cell phones
- WiFi routers
Learn more about:
- Food and Drugs Act
- Pest Control Products Act
- Radiocommunication Act
- Medical Devices Regulations
- Canada Consumer Product Safety Act
Modernizing the Act
Health Canada is looking at bringing the Radiation Emitting Devices Act and Regulations up to date. This will help to ensure that legislation reflects:
- technological advances
- increasing globalization
- the increase in the number and types of radiation emitting devices in Canada
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Radiation Emitting Devices Regulations
REDA states that radiation emitting devices must meet the specific requirements under its Regulations as applicable. Among other things, the Regulations set out radiation safety standards for labelling, construction and performance of some radiation emitting devices (prescribed classes).
Schedule I of the Regulations identifies the classes of devices that must meet the mandatory standards outlined in Schedule II.
Regulatory guidance documents
Health Canada prepares guidance documents that provide general information to regulated parties and stakeholders about the Acts and Regulations.
Learn more about:
- Radiation Emitting Devices Regulations
- Guidance document for cabinet X-ray equipment: Guide-001
- Guidance for laser products
Health Canada’s role
Health Canada administers REDA and its Regulations. This includes:
- promoting and enforcing regulatory compliance
- monitoring the safety and quality of radiation emitting devices
- engaging with stakeholders and providing radiation safety information to the public
- working with partners and contributing to the development of device radiation safety standards
We also develop guidelines and safety codes to help reduce risks posed by radiation emitting devices.
REDA does not require pre-market registration or authorization of devices by Health Canada.
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