Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 34

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 34
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, 2024, the UK government published an amendment to the UK Medical Devices Regulations to clarify and strengthen
the post-market surveillance requirements for medical devices in Great Britain. This amendment will come into force on June 16, 2025.
In addition, the MHRA launched a consultation from November 14, 2024 to January 5, 2025 on proposals to update the pre-market requirements
for medical devices in Great Britain. The MHRA has stated that it will incorporate feedback to this consultation into new UK legislation
on pre-market requirements for medical devices in Great Britain. The new legislation is expected to come into force in 2026. These modifications
may have an effect on the way we intend to conduct our business in these countries.

Changes in funding for, or disruptions caused
by global health concerns impacting, the FDA and other agencies or notified bodies could hinder their ability to hire and retain key leadership
and other personnel, or otherwise prevent new medical device products from being developed, authorized, certified or commercialized in
a timely manner, which could negatively impact our business.

The ability of the FDA, foreign
regulatory authorities and notified bodies to review and authorize or certify the sale of new products can be affected by a variety of
factors, including government budget and funding levels; its ability to hire and retain key personnel and accept the payment of user fees;
statutory, regulatory, and policy changes; and other events that may otherwise affect the FDA’s, foreign regulatory authorities’
and notified bodies’ ability to perform routine functions. Average review times at the FDA, foreign regulatory authorities and notified
bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and
development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA, other
agencies and foreign bodies may also slow the time necessary for new devices to be reviewed and/or authorized or certified for marketing
by necessary government agencies or foreign bodies, which would adversely affect our business. For example, in recent years, the U. S.
government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and
stop critical activities.

Separately, in response to
the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. If a prolonged
government shutdown occurs, or if renewed global health concerns continue to prevent the FDA, other regulatory authorities