Radiation Emitting Devices (REDA)
Overview
Some medical devices that emit radiation are regulated under the Radiation Emitting Devices Act (REDA, RSC 1985, c R-1) in addition to (or instead of) the Medical Devices Regulations. REDA is administered by Health Canada's Consumer and Hazardous Products Safety Directorate.
What REDA covers
REDA regulates devices that emit radiation in the form of:
- Electromagnetic waves (including X-rays, UV, visible light, infrared, microwave, radio frequency)
- Sound or ultrasound
- Ionising particles
Medical devices subject to REDA include:
- X-ray equipment (diagnostic X-ray, fluoroscopy, CT scanners)
- Radiation therapy devices (linear accelerators, brachytherapy)
- Diagnostic ultrasound devices (for radiation under REDA)
- Laser devices used medically
- UV therapy devices
- Microwave therapy devices
REDA vs MDR
Many devices subject to REDA are also regulated as medical devices under the MDR. In this case, both sets of requirements apply:
- MDR requirements for safety, effectiveness, labelling, and post-market
- REDA requirements for radiation safety and emission limits
For some radiation-emitting devices (e.g., certain consumer laser products), REDA may apply without the device being a medical device under the MDR.
REDA requirements
REDA establishes:
- Radiation emission standards for specific device categories (set out in schedules to the REDA Regulations)
- Labelling requirements for radiation warnings
- Performance requirements to protect users and bystanders from radiation exposure
- Testing and certification requirements before market entry
Compliance
Manufacturers of radiation-emitting medical devices must:
- Comply with the applicable REDA standard for their device type
- Test their device against the standard (self-testing or third-party testing)
- Certify compliance before selling in Canada
- Maintain records of testing
Legislative source: Radiation Emitting Devices Act, RSC 1985, c R-1; Radiation Emitting Devices Regulations, CRC, c 1370