Guidance on Device Licence Applications for Diagnostic Ultrasound Systems and Transducers – Health Canada Notice

Regulatory Classification and Scope

Diagnostic ultrasound systems and transducers are classified as Class II medical devices in Canada under the Medical Devices Regulations. This notice applies to complete diagnostic ultrasound systems (console-based or portable) and standalone transducers intended for diagnostic imaging purposes, including general imaging, cardiology, obstetrics/gynaecology, and other specialized applications. The guidance does not cover therapeutic ultrasound devices or systems used solely for guidance during procedures. Device Licence Applications for Diagnostic Ultrasound Systems and Transducers – Notice to Industry - Canada.ca

Licence Application Requirements

Manufacturers or importers must submit a complete Class II device licence application to Health Canada, including:

• Device description, intended use, and indications for use.
• List of all transducers compatible with the system, including model numbers and clinical applications.
• Evidence of compliance with applicable safety and performance standards (e.g., IEC 60601-2-37 for transducers, IEC 60601-1 for electrical safety).
• Acoustic output measurements and display indices (MI, TI) per IEC 62359 and FDA Track 3 guidance where relevant.
• Risk management file summary per ISO 14971.
• Quality management system certification (ISO 13485).
• Labelling, including user manual, acoustic output tables, and warnings (in English and French).

For transducers sold separately, applicants must demonstrate compatibility with licensed systems or provide standalone safety/performance data.

Performance Testing and Standards

Key expectations include:

• Acoustic output not exceeding FDA limits for relevant applications (or justification if exceeded).
• Imaging performance validation (resolution, penetration, contrast) using tissue-mimicking phantoms.
• Transducer-specific testing for mechanical/thermal indices, bandwidth, and beam characteristics.
• Software validation for image processing and measurement tools.

Health Canada may request additional data if the device introduces novel technology or targets high-risk populations (e.g., fetal imaging).

Labelling and Instructions for Use

Labelling must clearly state:

• Intended clinical applications for each transducer.
• Acoustic output indices (MI, TI) and derated values.
• Compatible systems and any restrictions.
• Cleaning/disinfection instructions.
• Warnings for sensitive tissues (e.g., eye, neonatal lung).

Instructions must be in English and French and include operator training requirements.

Post-Licence Considerations

• Any significant change (e.g., new transducer model, major software update) requires a licence amendment.
• Manufacturers must maintain vigilance reporting and comply with post-market surveillance obligations.
• Health Canada encourages early pre-submission consultation for novel or complex systems.

This notice streamlines the licensing process for diagnostic ultrasound devices while ensuring robust safety and performance verification. Detailed submission checklists, standards references, and contact information for pre-submission meetings are provided on the Health Canada guidance page. Device Licence Applications for Diagnostic Ultrasound Systems and Transducers – Notice to Industry - Canada.ca