Device licence applications for diagnostic ultrasound systems and transducers: Notice to industry

Date: 2026-01-19

Health Canada is issuing this notice to assist manufacturers in preparing new device licence applications for Class III and Class IV diagnostic ultrasound systems and transducers. This notice references relevant guidance documents, and provides acceptable acoustic output levels and key considerations for diagnostic ultrasound systems.

Device licence applications

Manufacturers must ensure that their devices comply with the regulatory requirements outlined in the Medical Devices Regulations.

For guidance on how to apply for a device licence, please refer to

• Health Canada IMDRF table of contents for medical device applications guidance
  and
• Health Canada guidance documents for medical devices

Manufacturers may choose to demonstrate conformance to recognized international standards to support claims of safety and effectiveness. For further information, manufacturers are directed to consult the following resources:

• Guidance on using standards to support compliance with the Medical Devices Regulations
• List of recognized standards for medical devices

To ensure comprehensive submissions, the applications must include but are not limited to the following information:

Intended use and indications for use

Include the intended use and indications for use of the ultrasound system, and the indications for use and clinical applications for each transducer or probe included in the system.

Clinical measurement accuracy

For each transducer/mode combination, provide the accuracy of any measurement (e.g., distance, volume, heart rate, Doppler frequency shift, velocity, indices, etc.) that can be made in that mode, and the range over which this accuracy can be expected to be maintained. Describe and justify the test methodology used to determine each accuracy.

Re-use instructions

Provide instructions for care of the device between uses, including storage, cleaning, disinfection and sterilization of all components, as appropriate. When appropriate, the labelling should recommend the use of sterile transducer sheaths licensed by Health Canada.

Acoustic output requirements

The term "Output Display Standard" is used in this notice to refer to the requirements relating to the display of the thermal index (TI) and the mechanical index (MI) set forward in IEC 60601-2-37. Refer to IEC 60601-2-37 for more information on the terms and definitions used herein. In this notice, I_SPTA.3 is the Derated Spatial-Peak Temporal-Average Intensity and I_SPPA.3 is the Derated Spatial-Peak Pulse-Average Intensity.

For systems in compliance with the "Output Display Standard"

Acoustic output should not exceed the following upper limits: I_SPTA.3=720 mW/cm² and either MI=1.9 or I_SPPA.3=190 W/cm². For ophthalmic applications (or any application whereby the ultrasound beam may pass through the eye), the upper limits are 1.0 for TI (maximum of either TIS_as or TIC), I_SPTA.3=50 mW/cm², and MI=0.23.

For systems not in compliance with the "Output Display Standard"

The global maximum derated acoustic output limits, given in Table 1, are deemed to be acceptable.

Note: for purposes of acoustic output limits:

1. trans-esophageal for non-cardiac use, intravascular, and musculo-skeletal applications are included in the "Fetal imaging & other" category;
2. cardiac use includes transthoracic adult and pediatric uses as well as intravascular and trans-esophageal adult and pediatric uses for visualization of the heart and coronary;
3. peripheral vessel use includes vessels of the neck; and
4. cephalic and transcranial are synonymous.

For fetal heart rate monitors, the maximum attainable value of spatial average, temporal average intensity (I_SATA) at the transducer face should be less than 20 mW/cm² for continuous wave devices and the maximum attainable value of the spatial average, pulse average intensity (I_SAPA) at the transducer face should be less than 20 mW/cm² for pulsed devices.

Contact

• For questions or further clarification, please contact:
  meddevices-instrumentsmed@hc-sc.gc.ca