Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 174

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 174
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e. g., a balloon cardiovascular catheter). These classifications
are compiled in a classification table describing thousands of product subcategories, which is updated from time to time by the MHLW,
reflecting introduction of new medical device.

For introduction to the Japanese
market, new Class I medical devices do not require any pre market regulatory action. In contrast, it is mandatory, for both Class III
and Class IV devices, to obtain pre marketing product approval which the MHLW grants on the basis of safety testing information, as well
as clinical trial information, when required. Class II devices (and part of Class III devices) are subject to the certification requirement
for compliance with the applicable product specifications, which are often developed under the ISO, before introduction into Japan. Certification
of these Class II devices is granted by private sector laboratories accredited in Japan.

At present, no mutual recognition
agreement is in force with either the United States or the European Union for medical device registration. Foreign registration of a medical
device, therefore, does not exempt products registered in these regions from the Japanese registration requirement. However, the MHLW
will accept foreign electric or other safety data as well as foreign clinical trial data for the purpose of Japanese registration.

Approval and clinical trial

For approval of a new Class
III/IV medical device product, the applicant (which can be either a foreign manufacturer or its distributor in Japan) is required to submit
a package of information required by the Japanese regulations which are largely consistent with the Global Harmonization Task Force (“ GHTF”)’s
regulatory recommendations. For example, the manufacturer is required to prepare documentation and test results demonstrating compliance
with the Essential Principles of Safety and Performance, which are largely identical to the general safety and performance requirements
of the European Union, such as a risk management program and safety and efficacy documentation.

Unlike the case of pharmaceuticals,
not all new medical devices are required to submit clinical trial data to prove safety and efficacy. In particular, new products without
“evident” improvement from existing products may be approved with clinical information of a limited size, if they do not pose
a new, material clinical risk. On the other hand, truly innovative medical devices have to be tested through a clinical trial, but the
domestic clinical trial can be limited or waived if the foreign/international pivotal clinical trial data is available. Importantly, the
authorities’ guidance document provides that “clinical significance”, or operability by Japanese healthcare providers
(“ H