Japan’s regulatory requirements for Software as a Medical Device (SaMD)
£35.00
Navigate Japan’s complex SaMD regulations with this comprehensive guide, ensuring compliance and smooth market entry for your software-based medical products
English
Whether software constitutes a medical device under Japanese law requires careful consideration due to the substantially different regulatory regimes applicable to regulated and unregulated software products. Ryosuke Tateishi provides an overview of the regulations applicable to software that constitutes a medical device (i.e. Software as a Medical Device, SaMD) under Japanese law. The article considers the legal framework for SaMD in Japan, the treatment of SaMD under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the scope of SaMD, Ministry guidelines, and disease risk indicating software.
Specification: 8 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2024 issue of the Journal of Medical Device Regulation.
