Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 32

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 32
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 products or we may be unable to do so on a timely basis.
The time required to obtain registrations, certifications and marketing authorizations, if required by other countries, may be longer
than that required for FDA marketing authorizations, and requirements for such certifications, registrations or authorizations may significantly
differ from FDA requirements. If we modify our products, we may need to apply for additional marketing authorizations or certifications
before we are permitted to sell the modified product. In addition, we may not continue to meet the quality and safety standards required
to maintain the authorizations or certifications that we have received. If we are unable to maintain our marketing authorizations or certifications
in a particular country, we will no longer be able to sell the applicable product in that country.

Obtaining marketing authorization
from the FDA does not ensure similar marketing authorization or certifications by regulatory authorities or notified bodies in other countries,
and registration, marketing authorization or certification by one or more foreign regulatory authorities or notified bodies does not ensure
registration, marketing authorization or certification by regulatory authorities or notified bodies in other foreign countries or by the
FDA. However, a failure or delay in obtaining registration, marketing authorization or certification in one country may have a negative
effect on the regulatory process in others.

Legislative or regulatory reforms in the
United States or the EU may make it more difficult and costly for us to obtain marketing authorizations or certifications for any product
candidate or to manufacture, market or distribute any product candidates after such authorizations or certifications have been obtained.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of medical devices.
In addition, the FDA may change its policies, adopt additional regulations or revise existing regulations, or take other actions, which
may prevent or delay marketing authorization of our future products under development or impact our ability to modify any products for
which we have already obtained marketing authorizations on a timely basis. For example, in February 2024, the FDA issued a final rule
to amend and replace the Quality System Regulation, or QSR, which sets forth the FDA’s current good manufacturing practice requirements
for medical devices, to align more closely with the International Organization for Standardization standards. Specifically, this final
rule, which the FDA expects to go into effect on February 2, 2026, establishes the “ Quality Management System Regulation,”
or QMSR, which, among other things, incorporates by reference the quality management system requirements of ISO 13485