Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 176

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 176
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 medical devices than in the case of the pharmaceuticals which are given a much longer post
marketing surveillance period (8 years for a new API). Indeed, unlike chemical compounds or biological preparations, medical device manufacturers
frequently improve and update device models and software to compete in the market, rather than relying on the patents or data exclusivity.

Safety reports

After approval, incidents
impacting on safety and efficacy of the medical device products marketed in Japan must be reported within 15 days or 30 days of the date
when the Japanese distributor becomes aware of the incident. These periods begin counting on the date the relevant information is received
by the Japanese distributor, and not the date when the foreign manufacturer has found the incident. In the past, quite a few Japanese
distributors sometimes failed to collect overseas information and file a timely report, resulting in regulatory penalties.

In addition, the distributor
is also required to file a periodic safety report to the authorities collecting information on serious incidents as well as unexpected
incidents.

Reimbursement

Reimbursement for medical
devices in Japan is centralized, as it is covered by the Japanese National Health Insurance (NHI). Institutions who purchased the reimbursable
medical devices receive monetary compensation either in the form of price reimbursement (for consumable medical devices), or through their
professional/technical fees (for non-consumables such as CT scanners, automated surgical robotics).

When a new Class III/IV non-consumable
device product is granted approval, the manufacturer who wishes to obtain the reimbursement status under the NHI must submit a reimbursement
proposal to the MHLW. Upon receipt of the proposal, the Ministry will task the advisory body to evaluate if the new medical device would
require a new technical fee for reimbursement, or would be reimbursable under the existing technical fee. If the product is entirely new,
a new technical fee will be created, under which the fee will be payable to the institution when the device is used for treatment. On
the other hand, the authorities may determine that the existing (generic) technical fee covers the new technology, and simply add the
new medical device as being eligible for NHI reimbursement under the technical fee. In the latter case, the new product will have to compete
with the existing products for compensation from the same technical fee payable to the institution.

Compliance, promotion and advertisement

The law in Japan was amended
in 2020 to strengthen the compliance mechanism inside the corporate structure of the holder of the product approval. Specifically