Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 44

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 44
---
ifications
or PMAs for modifications to our previously authorized products for which we have concluded that new authorizations are unnecessary, we
may be required to cease marketing or to recall the modified product until we obtain appropriate regulatory authorization, and we may
be subject to significant regulatory fines or penalties. In addition, the FDA may not authorize our products for the indications that
are necessary or desirable for successful commercialization or could require clinical trials to support any modifications. Any delay or
failure in obtaining required regulatory authorizations would adversely affect our ability to introduce new or enhanced products in a
timely manner, which in turn would harm our future growth.

Our products
must be manufactured in accordance with any applicable federal, state and/or foreign regulations, and we could be forced to recall our
installed systems or terminate production if we fail to comply with these regulations.

The methods used in, and the facilities used for,
the manufacture of our products must comply with the FDA’s QSR, which is a complex regulatory scheme that covers the procedures
and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution,
installation, servicing, and shipping of medical devices. Furthermore, we are required to verify that our suppliers maintain facilities,
procedures and operations that comply with our quality standards and applicable regulatory requirements. Compliance with the QSR is necessary
to receive FDA clearance or approval to market new products and is necessary for a manufacturer to be able to continue to market cleared
or approved devices in the United States. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device
manufacturing facilities, which may include the facilities of subcontractors. Our products are also subject to similar state regulations
and various laws and regulations of foreign countries governing manufacturing. Foreign regulatory authorities also impose manufacturing
quality requirements, that may differ from the FDA requirements, with which we must comply.

Additionally, the FDA substantively revised the QSR regulation
in 2024, which is now titled the Quality Management System Regulation (“ QMSR”). If the new Trump administration continues
the Biden administration’s efforts to implement the revision and maintain the current schedule, this new regulation will likely
become effective February 2, 2026.

We or our third-party suppliers may fail to
take the necessary steps to comply with applicable regulations, including regulatory changes, which could cause delays in the
delivery of our products. In addition, failure to comply with applicable FDA or foreign jurisdiction requirements or later discovery