Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to device license applications for ultrasonic diagnostic systems and transducers.
The document is intended to provide medical device manufacturers with additional clarifications regarding the applicable regulatory requirements to be considered when applying for approval for the marketing and use of such devices in Canada. In particular, the present article describes the recommendations provided by Health Canada with regard to the content of the application and outlines the scope of information the authority expects an applicant to provide.
General Device Description and Background Information
First, according to Health Canada’s guidance, an applicant shall provide a general description of the subject device, including but not limited to the model, designation, design, patient contact materials, operating controls, and system operation. Additionally, an applicant shall provide information about accessories intended to be used with the device in question, even if they are marketed separately.
A separate form to be filled by the applicant is dedicated to the indication for use for a medical device subject to review.
With regard to the transducer operations, an applicant shall provide such details as:
- Type of transducer (e.g., model designation, mechanical sector, rectangular phased array, curved linear array, annular phased array);
- Size and spacing of element(s), geometrical configuration, the total number of elements in the array and array dimensions, as well as the maximum number of active elements for a single pulse, where applicable, and the nominal ultrasonic frequency(its) of the transducer assembly.
Additionally, an applicant shall provide information about:
- Operating controls (for instance, those impacting the sector angle or pulse duration);
- Unique features of the device in question;
- Marketing history, including a complete list of countries in which the product in question is currently available, the number of items sold, as well as summaries of incident reports and corrective actions taken by the manufacturer in this regard (e.g., recalls).
Safety and Effectiveness Studies
According to section 32(3)(f) of the Medical Device Regulations, the medical device manufacturer shall duly provide a summary of all the studies that could be used as reference when demonstrating compliance of the device in question with the applicable safety and effectiveness requirements set forth by the Regulations.
If a new device utilizes technologies used in similar medical devices already placed on the market, it would be sufficient to demonstrate equivalence to such devices in terms of specifications and performance.
Additionally, medical device manufacturers are allowed to refer to the applicable standards for demonstrating compliance with the safety and effectiveness requirements to which the device should be subject.
If there is a standard relevant for the medical device in question, the medical device manufacturer has to:
- Meet the standard; or
- Meet an equivalent or a better standard; or
- Provide alternate evidence of safety or efficacy.
Should the manufacturer decide to use alternative options (second and third), the appropriate justification should be provided.
In this context, the guidance also refers to the List of Recognized Standards for Medical Devices developed and published by the authority.
If the medical device in question is intended to be supplied sterile, the manufacturer shall also submit detailed information describing the particular sterilization method employed and the ability of the packaging to ensure that the device remains sterile within its projected shelf life, provided all storage and transportation requirements prescribed by the manufacturer are followed.
In particular, the application shall contain information about:
- Type of sterilization process,
- Level of sterility assurance, and
- Attestation or certification that the process has been properly validated.
Health Canada’s guidance further outlines the scope of information the manufacturer shall provide with regard to all components of the device that are provided sterile.
Section 32(3)(f) requires the manufacturer applying for marketing approval to provide a summary of studies to which the product in question was subject. In this regard, the manufacturer shall provide information about:
- Clinical Measurement Accuracy and System Sensitivity for each device, together with the detailed description of the particular test methodology used.
- Performance Specifications, including a minimum performance specification and justification of a methodology.
- Accepted Acoustic Output Levels – the scope of information to be provided in this regard depends on the compliance of the product in question with the AIUM/NEMA 2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
- Certifications. The medical device manufacturer shall duly demonstrate compliance with the applicable standards recognized by the authority or justify deviations thereof (if any).
- Default Settings, expressed as a percentage of the maximum levels, together with the explanations of the reasons behind using these particular settings.
- Thermal Index – should it exceed a value of 6.0, an appropriate justification should be provided.
- Low Output Systems.
- Thermal, Mechanical, and Electrical Safety – the manufacturer shall demonstrate the safety of the system by providing either a declaration of conformity referring to the applicable standards, or information related to the design of the device, demonstrating its safety. According to the guidance, this may be provided in the form of descriptions, safety precautions, testing, and data to support the electrical and mechanical safety of the device. It would also be acceptable to refer to third-party certification.
- Patient Contact Material. The application shall contain detailed information about any and all materials used to manufacture the elements of the product in question that are intended to be in contact with the patient. In particular, the manufacturer shall provide information sufficient to identify these materials, as well as a declaration of conformity demonstrating compliance with the relevant standard dedicated to biocompatibility (ISO 10993) or information about the appropriate testing conducted in accordance with the applicable recognized standard. Should the materials used in a new medical device already be approved for use by the authority when used in other medical devices already placed on the market, it would be sufficient to provide references (device license numbers) in order to justify the use of such materials and demonstrate conformity to the applicable regulatory requirements.
- Software/Firmware. The manufacturer shall provide sufficient information about the software/firmware which operates the device in question. The authority additionally mentions that significant changes to software must be validated and verified. The authority also acknowledges that due to the complexity of the device, different functions could be operated by different software components (modules).
In general, the information to be provided by the manufacturer with regard to the software operating the device should include:
- A summary description of new and altered algorithms and an explanation why they are considered suitable for the task;
- The software version number;
- A software structural chart;
- A system hazard analysis;
- A listing of the specific hardware/software requirements;
- A summary of the software design and development process, including the software change management process; and
- A summary of the software verification and validation processes.
In summary, the present Health Canada guidance describes in detail the scope of information to be provided by the applicant (medical device manufacturer) with regard to the medical device subject to review. The document also provides recommendations on the way compliance with the applicable regulatory requirements on safety and effectiveness could be demonstrated.
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