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Our Latest Publication:    November 2026 – Volume 23, Issue 4
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Inconsistencies in terminology for SaMD and DTx in regulatory frameworks

£49.00

Understand how differing SaMD and DTx terminologies across global regulatory frameworks impact product classification, clinical evidence and market access

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English

Abstract:

While Software as a Medical Device (SaMD) and digital therapeutics (DTx) are key drivers of innovation in health technologies, inconsistent terminology across regulatory frameworks influences product classification, regulatory pathways, clinical evidence required for regulatory approval, and the management of software updates. Such inconsistencies can also cause miscommunication between developers and regulatory authorities. Consequently, developers can encounter significant challenges in designing multi-regional clinical trials, preparing a single global regulatory submission package, and maintaining harmonised product versions.
This article by Takashi Hosono, Yuki Niwa and Masuo Kondoh summarises and evaluates the terminology used by four international bodies relating to SaMD and DTx, including artificial intelligence (AI)- and machine learning (ML)-enabled products, to gain a better understanding of their similarities and differences. The adoption of this terminology across eight countries/regions was also investigated, along with any relevant self-defined terminology.
The results revealed a conceptual divergence in terminology used for SaMD and DTx across the regulatory frameworks that requires careful attention. To address this, international bodies should consider using clearer and more harmonised terminology, particularly for AI- and ML-enabled SaMD and DTx. At the same time, developers should analyse terminology differences and their regulatory implications at early stages of development.

 

Learning objectives:

  • Understand conceptual divergence in terminology for SaMD and DTx across regulatory frameworks.
  • Raise awareness of the need for proactive international harmonisation of terminology, especially for AI/ML-enabled SaMD and DTx.
  • Assist developers in preparing global development strategies and harmonised product versions at early stages of development.

 

About the authors:

Takashi Hosono, PhD and MBA, is an employee at NS Pharma, Inc and a visiting researcher at The University of Osaka. His research focuses on regulatory science for digital therapeutics.

Yuki Niwa, PhD, is an assistant professor in the faculty of pharmaceutical sciences at The University of Osaka. His research focuses on regulatory sciences for pharmaceuticals and medical devices.

Masuo Kondoh, PhD, is a professor in the faculty of pharmaceutical sciences at The University of Osaka. His research focuses on regulatory sciences for pharmaceuticals and medical devices.

 

Specification:

10 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the November 2026 issue of the Journal of Medical Device Regulation.

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