Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 175

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 175
---
CPs”) in the Japanese clinical environment is a most important point of reference for a new medical device. For this reason,
even when domestic clinical trial data is required, the scope of the trial is limited to applicability of the new technology to the Japanese
clinical environment, the number of subjects is limited, and comparative data is not essential.

Separately, in order to expedite
introduction of new medical devices from overseas, the authorities accept, in lieu of clinical trial results, a “clinical evaluation
report” which proves the risks and benefits of the new medical device based on published professional information on the mechanism
and operation of the device.

Quality management systems

In addition to the approval
requirements, manufacturers of Class III/IV medical devices, either domestic or foreign, are required to observe the Japanese quality
management systems (QMS) requirements and obtain certification of compliance from the authorities. The QMS requirements are largely identical
to those under ISO 13485, and cover matters including adequate documentation of manufacturing processes in the form of SOPs, adequate
staffing and the PDCA cycle procedure.

Post-marketing surveillance and
“data exclusivity”

In contrast to new pharmaceuticals,
which are typically given a post marketing surveillance period for a certain number of years to assess the safety and efficacy of the
new product upon approval, not all newly approved medical devices are subject to the post marketing surveillance requirement. Since 2014,
the MHLW requires post marketing surveillance only for “evidently” new medical devices in terms of its mechanical structure,
usage, operative procedures, or efficacy, and which have not been used either in Japan or abroad. The post marketing surveillance period
is, in principle, 3 years, and generally 5 years for embedded products or orphan products which require a long term observation or a larger
number of clinical cases to fully assess the product profile. These determinations are made by the MHLW on a case by case basis, and the
Ministry may set the period up to 7 years if it finds necessary.

Notably, when a new product
is assigned a post marketing surveillance period, it is the policy of the MHLW to require similar follow on products to submit the equivalent
set of date (in particular clinical trial data) to obtain approval, as the right of reference is not automatically granted to competitors.
This operation of the post marketing surveillance to block follow on applications is known as the “data exclusivity.” However,
the data exclusivity is less important for