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Hi, my name is
Samuel Olaniyi

Japanese to English

legal

general

novel

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Sample Translation Software

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Source (Japanese)	Target (English)
資産としてのソフトウェア	Software as an asset
ソフトウェアは法律上、知的財産として扱われ、著作権法や特許法によって保護される。	Software is treated as intellectual property by law and is protected by copyright and patent laws.
一般的には著作者がそのソフトウェアの利用範囲を明確にした利用許諾契約書を用意しており、ソフトウェアの利用者はこれに合意しなければならない。	Generally, the developer prepares a license agreement that clearly defines the scope of use of the software, and the user of the software must agree to it.
この契約内容の一部を、ソフトウェアライセンスという。	This section of the agreement is called the software license.
著作権者が利用許諾契約書を用意していない場合は著作権法の範囲での利用が可能である。	If the copyright owner has not prepared a license agreement, the software can be used within the scope of the Copyright Act.
医療用ソフトウェアの規制	Regulations on Medical Software
「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（略称:医薬品医療機器等法、薬機法、旧称：薬事法）」により、疾病診断用プログラム、疾病治療用プログラム、疾病予防用プログラム、および、それらを記録した記録媒体についても、副作用又は機能の障害が生じた場合において、人の生命及び健康に影響を与えるおそれがある場合には、医療機器として制限を受ける。	Under the "Law on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Device Act, abbreviated as PMD Act, and formerly known as the Pharmaceutical Affairs Law)", software programs for the diagnosis of diseases, treatment of diseases, prevention of diseases, and their storage media are also regulated as medical devices if there's a risk of side effects or the impairment of function that may affect human life and health.
これは、医療機器のIT化に伴って、医療的な効果を謳うソフトウェア単体についても他の医療機器と同様の規制が必要になったためである（医薬品医療機器等法第23条の2関係、医薬品医療機器等法第39条関係）。	This is because, along with the introduction of IT to medical devices, the same regulations as other medical devices have become necessary for software that claims medical benefits (Re. Article 23-2 of the Pharmaceuticals and Medical Device Law and Article 39 of the Pharmaceuticals and Medical Device Law).

South Africa

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April 2024

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