Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 33

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 33
---
:2016. Although the
FDA has stated that the standards contained in ISO 13485:216 are substantially similar to those set forth in the QSR, it is unclear the
extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase
the costs of compliance or otherwise negatively affect our business.

In addition, FDA regulations
and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new
statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of
any product candidates or make it more difficult to obtain marketing authorizations for, manufacture, market or distribute any product
candidate we are developing. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements
or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or
sustain profitability.

In addition, the EU regulatory
landscape concerning medical devices evolved and on May 26, 2021, the EU Medical Devices Regulation (Regulation 2017/745) became applicable,
which repeals and replaces the EU Medical Devices Directive and the Active Implantable Medical Devices Directive (See “- Regulation
of Medical Devices in the European Union”) and these modifications may have an effect on the way we conduct our business in
the EU and the EEA. For example, as a result of the transition towards the new regime, notified body review times have lengthened, and
product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business.

The EU-UK Trade and Cooperation
Agreement, or TCA, came into effect on January 1, 2021. The TCA does not specifically refer to medical devices but does provide for cooperation
and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and measures,
standardization related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For medical devices
that are locally manufactured but use components from other countries, the “rules of origin” criteria need to be reviewed.
Depending on which countries products will be ultimately sold in, manufacturers may seek alternative sources for components if this would
allow them to benefit from no tariffs. The rules for placing medical devices on the Northern Ireland market differ from those in Great
Britain. On December 16