Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 148

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 148
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  the FDA’s recall authority, whereby the agency can order device manufacturers                    

  post-market surveillance activities and regulations, which apply when deemed by the                                 

We may be subject to similar foreign laws that may
include applicable post-marketing requirements such as safety surveillance and risk-benefit analysis. Our manufacturing processes are
required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture,
testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished
devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and
complaint files. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain
compliance with the QSR requirements could result in the shut-down of, or restrictions on, our manufacturing operations, and the recall
or seizure of our products. The discovery of previously unknown problems with any of our products, including unanticipated adverse events
or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance
or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product
from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory compliance and enforcement
powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or
enforcement actions, which may result in any of the following sanctions:

  warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties;  

  recalls, withdrawals, or administrative detention or seizure of our products;  

  operating restrictions or partial suspension or total shutdown of production;  

  refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;  

  withdrawing 510(k) clearances or PMA approvals that have already been granted;  

  refusal to grant export or import approvals for our products; or  

  criminal prosecution.  

U. S. and Foreign Healthcare Laws and Compliance Requirements

Healthcare providers, physicians, and third-party
payors play a primary role in the recommendation, prescription, and payment for medical treatments. A medical device manufacturer’s
arrangements with third-party payors, providers, and patients may expose it to broadly applicable fraud and