Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order

Barry Solaiman*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

This paper examines the Saudi Food and Drug Authority’s (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical Device Marketing Authorization. The regulation of AI in health is at an early stage worldwide. Therefore, it is critical to examine the scope and nature of the MDS-G010, its influences, and its future directions. It is argued that the guidance is a patchwork of existing international best practices concerning AI regulation, incorporates adapted forms of non-AI-based guidelines, and builds on existing legal requirements in the SFDA’s existing regulatory architecture. There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS-G010 is complex. There are binding ‘components’ within the guidance, but the incorporation of non-binding international best practices which are subordinate to national law results in a lack of clarity about how penalties for non-compliance will operate.

Original languageEnglish
Pages (from-to)373-389
Number of pages17
JournalAsian Bioethics Review
Volume16
Issue number3
DOIs
Publication statusPublished - Jul 2024

Keywords

  • Artificial intelligence (AI)
  • Data
  • Health
  • Law
  • Medical devices
  • Saudi Arabia

Fingerprint

Dive into the research topics of 'Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order'. Together they form a unique fingerprint.

Cite this