Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 173

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 173
---
 Protocol, Northern Ireland follows EU rules on medical devices and devices marketed in Northern Ireland require assessment according
to the EU regulatory regime. Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing
the device on the market in the EU or Northern Ireland. Alternatively, if a UK notified body conducts such assessment, a ‘ UKNI’
mark and a CE mark are applied and the device may only be placed on the market in Northern Ireland and not the EU.

Israel’s Regulations of our Products

Our product candidates require
approval by the Israeli Ministry of Health for sale and distribution in Israel. Our manufacturing activities in Israel are also subject
to regulation by the Israeli Ministry of Health, in addition to the radioactive aspect of our manufacturing which is subject to regulation
by the Israeli Ministry of Environmental Protection. In addition to approvals related to marketing and selling our products, once approved,
we or our clinical trial partner sites also must obtain pertinent approvals or permits to perform our clinical trials in the countries
in which we perform such trials, such as in compliance with an international guideline for the ethical conduct of clinical research known
as the Declaration of Helsinki. In Israel, our clinical trials require a permit for a research plan (protocol) by the Helsinki Committee,
operating under the Israeli Public Health Regulations (Clinical Trials in Human Subject Research), 1980.

Japan’s Regulations of Medical Devices

Medical devices are defined
as “appliances or instruments, etc. which are intended for use in the diagnosis, treatment or prevention of disease…,”
which are classified into 85 broad product categories under the implementing Cabinet Order, such as “physical diagnostic and treatment
devices” or “radioactive material treatment devices”, based on product features and functionalities. If a product falls
under any of these categories, it will be regulated as a medical device For regulatory purposes, the medical devices are given classification
of Class I through IV, based upon their potential safety concerns and health risks. For example, a simple device such as blood pressure
meter is Class I, whereas products with potential health risks but for which technology is well established in the form of ISO specifications
are Class II (e. g., a pulse oximeter). More advanced products with significant safety concerns are Class III (e. g., a heart pacemaker).
Finally, the Ministry of Health, Labor and Welfare (“ MHLW”) designates part of Class III devices as Class IV which covers
those invasive items with significant safety concerns which may impair human lives (