Radiation Emitting Devices Act (REDA)
Overview
The Radiation Emitting Devices Act (RSC 1985, c R-1) regulates devices that emit electromagnetic radiation (including X-rays, UV, visible light, infrared, microwave, radiofrequency) and sonic or ultrasonic waves. It is administered by Health Canada's Consumer and Hazardous Products Safety Directorate.
Relationship to the Medical Devices Regulations
Many medical devices that emit radiation are regulated under both REDA and the Medical Devices Regulations:
- The MDR governs their medical device aspects (safety, effectiveness, labelling, licensing)
- REDA governs their radiation emission characteristics (performance standards, emission limits)
For some radiation-emitting products that are not medical devices (e.g., microwave ovens, laser pointers), only REDA applies.
Devices covered by REDA
REDA applies to devices listed in Schedule I of the Radiation Emitting Devices Regulations (CRC, c 1370). Medical devices in Schedule I include:
- Diagnostic X-ray equipment
- Therapeutic X-ray equipment (radiation therapy)
- Microwave therapy devices
- Ultrasound therapy devices
- UV therapy devices
- Laser devices
REDA requirements
For each device category in Schedule I, REDA sets out:
- Performance standards — emission limits and safety requirements
- Testing requirements — how compliance must be demonstrated
- Labelling requirements — radiation warning labels
- Reporting obligations — for new models
Manufacturers and importers of radiation-emitting devices must comply with the applicable REDA standard before the device can be sold in Canada.