Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 48

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 48
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 injunctions, administrative penalties or civil
or criminal fines.

Companies are required to maintain certain records
of corrective actions, even if they are not reportable to the FDA. We may initiate voluntary corrective actions for our products in the
future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, it could require us to
report those actions as recalls, and we may be subject to enforcement action. A future recall announcement could harm our reputation with
customers, potentially lead to product liability claims against us and negatively affect our sales.

Any adverse event involving Deep TMS systems could
result in voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection, mandatory recall
or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as exposing us to private litigation, would
require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial
results.

If we or our
distributors do not obtain and maintain international regulatory registrations or approvals for Deep TMS, we will be unable to market
and sell our products outside of the United States.

Sales of our Deep TMS systems outside of the United
States are subject to foreign regulatory requirements that vary widely from country to country. While the regulations of some countries
may not impose barriers to marketing and selling Deep TMS systems or only require notification, others require that we or our distributors
obtain the approval of a specified regulatory body. Complying with foreign regulatory requirements, including obtaining registrations
or approvals, can be expensive and time-consuming, and we or our distributors may not receive regulatory approvals in each country in
which we plan to market Deep TMS or we may be unable to do so on a timely basis. The time required to obtain registrations or approvals,
if required by other countries, may be longer than that required for FDA authorization, and requirements for such registrations, clearances
or approvals may significantly differ from FDA requirements. If we modify our Deep TMS systems, we or our distributors may need to apply
for additional regulatory approvals 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 that we or our distributors have received. If we or our distributors
are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country.

Regulatory authorization by the FDA and/or