To speed up the approval process of new devices with demands and practical feasibility, the Japanese Ministry of Health, Labour and Welfare publishes a list of possible evaluation points when reviewing those devices.

On June 9th, 2022, MHLW newly announced evaluation points for additional two devices:
(1) Brest Cancer Diagnosis Device
(2) SaMD with Behavior Change

In this article, we will introduce definitions of the two devices for those manufacturers of similar products who plan to enter the Japanese market. Please keep in mind that these evaluation points are not legal criteria for approval, and thus consultation with PMDA is heavily advised by the announcement.

1. Breast Cancer Diagnosis Device

Major breast cancer diagnosis devices in the Japanese market are x-ray mammography and ultrasonography. However, due to the physical burden and insufficient efficacy that are brought to patients, new modalities are sought and developed: (1) Microwave Imaging, (2) Ultrasound CT and (3) Photoacoustic Imaging.

The targets of the published evaluation points are specifically for devices having one of these three modalities. Their definitions are as follows:

(1) Microwave Imaging

Microwave imaging features low energy and non-ionizing radiation compared to x-ray. Its method of diagnosis is to use dielectric contrast to check whether there is cancer or not. Along with development of real-time imaging technology, it is expected to be a safe screening technology that can be done frequently.

(2) Ultrasonic CT

Ultrasonic CT is a device that obtains ultrasonic scattering images, sound velocity distribution images, and attenuation distribution images by surrounding application site with ring array. Its obtained images achieve high resolution which is comparable to MRI and is expected to come into wide use as an inexpensive and non-invasive device.

(3) Photoacoustic Imaging

Photoacoustic imaging is a technology that receives ultrasound waves generated by the photoacoustic effect of nanosecond-width pulsed light that is radiated to the patient body. It is a novel imaging technology that can noninvasively visualize high-resolution structural information of micro vessels and functional information such as oxygen saturation-related indices.

  1. 2. SaMD with Behavior Change
    With the rapid development of “Internet of Things (IoT,)” software as a medical device (SaMD) that provides processed information to patients by patient-derived data is actively being developed. In the published announcement, “Behavior Change” is defined as:

    Bringing clinical efficacy (treating or preventing disease) by changing the patient’s daily lifestyle with interventions such as psychological therapy, using process data that is derived from the patient.

    Examples of targeted medical conditions of these devices are diabetes, hypertension, non-alcoholic steatohepatitis, alcohol health disorders, cancer, sleep disorders, or dementia.

For more detailed information about evaluation points for these devices, please contact Qualtech’s business team directly.



MHLW Announced Evaluation Items for Breast Cancer Diagnosis Device and SaMD with Behavior Change