Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 41

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 41
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 for our products; or pursuing criminal prosecution.
Any of these sanctions could impair our ability to produce or commercialize our products in a cost-effective and timely manner in order
to meet our customers’ demands and could have a material adverse effect on our reputation, business, results of operations, and
financial condition. We may also be required to bear other regulatory compliance costs or take other actions that may have a negative
impact on our sales and our ability to generate profits.

In addition, the FDA may change its clearance and approval policies, adopt additional regulations
or revise existing regulations, or take other actions, which may prevent or delay authorization of our future products under development
or impact our ability to modify our currently marketed products on a timely basis. Such policy or regulatory changes could impose additional
requirements upon us that could delay our ability to obtain new 510(k) clearances or other classifications or approvals, increase the
costs of compliance or restrict our ability to maintain our current clearances and de novoauthorization. We also cannot predict
the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action
in the United States, especially with the new Trump administration, which has already implemented a number of policy changes that are
likely to impact our industry. In addition to substantive policy changes, the new Trump administration’s push for deregulation,
a reduction of federal funding, and a reduction of the federal workforce in agencies including in the Department of Health and Human Services
(“ DHHS”) may lead to delays in approvals or clearances, unpredictable enforcement, abrupt policy changes, and many other forms
of regulatory volatility that may destabilize our industry and could have a material adverse effect on our business.

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In order to sell our products in member countries
of the European Economic Area (EEA), or in countries that also rely on the CE Mark outside the EEA, our products must comply with the
General Safety and Performance Requirements of the Medical Device Regulation (Regulation 2017/745) and the ISO 13485:2016 standard for
Medical devices (Quality management systems, Requirements for regulatory purposes). Compliance with these requirements is a prerequisite
to be able to affix the CE Mark to our products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with
the General Safety and Performance Requirements we must undergo a conformity assessment procedure, which varies according to the type
of medical device and its classification. Except for low-risk medical devices (Class I