Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 42

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 42
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 non-sterile, non-measuring devices), where the
manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential
requirements of the Medical Devices Regulation, a conformity assessment procedure requires the intervention of an organization accredited
by a Member State of the EEA to conduct conformity assessments, a Notified Body. Depending on the relevant conformity assessment procedure,
the Notified Body would typically audit and examine the technical file and the quality system for the manufacture, design, and final inspection
of our devices. We are audited and certified for ISO 13485, Quality Management System, under the Medical Device Single Audit Program (MDSAP),
which means that we undergo a single audit of our quality management systems (QMS) to satisfy the regulatory requirements of multiple
jurisdictions, such as the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA) and Australia (TGA). In order to
market class II (or above) medical devices in Canada, an MDSAP certificate is mandatory. The Notified Body issues a certificate of conformity
following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer
and their conformity with the General Safety and Performance Requirements. This certificate entitles the manufacturer to affix the CE
Mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. If we fail to remain in compliance
with applicable European laws and directives, we would be unable to continue to affix the CE Mark to our device, which would prevent us
from selling them within the EEA and may have an impact on our marketing authorizations in other countries.

We or our distributors will also need to obtain,
or retain, regulatory approval in other foreign jurisdictions in which we plan to or currently market and sell our products, and we or
they may not obtain such approvals as necessary to commercialize our products in those territories. Regulatory marketing authorizations
in these foreign jurisdictions typically require device testing, conformance to classification requirements, pre-market requests to authorize
commercialization, and in some cases, inspections and/or a local presence in the territory for the approval holder.

Any modification to a 510(k)-cleared product that
could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture,
requires a new 510(k) clearance or de novoclassification, or possibly, a P