All Software as a Medical Device (SaMD) articles
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JournalWearable technology: The fine regulatory line between health and wellness
This article analyses the distinction between medical devices and ‘lifestyle’ technologies and the regulatory, commercial and ethical considerations created by this form of market positioning.
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ContentsRegulatory Rapporteur February 2026 – Contents
The February issue of Regulatory Rapporteur focuses on MedTech.
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EditorialMedTech in transition: Regulation, risk and real-world impact
This issue is shaped by a unifying theme: how risk, evidence, inclusivity and innovation are being brought to the forefront by evolving regulatory expectations across the medical device lifecycle.
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JournalBridging the digital divide: A toolkit for equity-centred regulation of digital mental health
This article offers an overview of a proposed toolkit to support regulators and developers in embedding equity into digital mental health technology workflows.
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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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JournalAI meets medtech:
big opportunities
require a
measured approachRegulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Artificial intelligence (AI) and machine learning (ML)-enabled digital health technologies have great potential to improve patient care, strengthen diagnostic capabilities and enhance treatment options. Governments and healthcare professionals understand ...
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JournalIMDRF: Origins, purpose and current work
In a landscape of rapidly evolving technologies, the International Medical Device Regulatory Forum (IMDRF) aims to accelerate international medical device harmonisation. A summary of the work being undertaken by the IMDRF.