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<p>The integration of sensor technology and medical devices revolutionized healthcare as it allowed real-time monitoring, timely diagnosis, and targeted therapy. But with the fast pace of technological advancement and use of biomaterials, regulatory barriers are created where authorities have to weigh innovation against patient safety. The review discusses the regulation of sensor-based medical devices in India, Canada, and Australia concerning market trends, regulating authorities, device classification, approval timelines, pre-market submission, post-market surveillance, cybersecurity requirements, and recent developments. It emphasizes the increasing importance of biomaterials in improving sensor performance and the imperative for harmonized quality and safety standards. The review also emphasizes the importance of international regulatory harmonization and common frameworks for the incorporation of sensor technology into biomaterial-based products, digital medicine, and AI-based compliance systems. By balancing innovation and patient protection, this review is highly beneficial to manufacturers, researchers, and healthcare professionals for improving their performance in the ever-changing regulatory environment.</p>

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Global Regulatory Perspectives on Sensor-Enabled and Biomaterial-Integrated Medical Devices: A Focus on India, Canada, and Australia

  • 期刊论文

  • 发表日期：

    2025年4月1日

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  • Sahil Jamil Mulla,
  • Mital Patel

摘要

The integration of sensor technology and medical devices revolutionized healthcare as it allowed real-time monitoring, timely diagnosis, and targeted therapy. But with the fast pace of technological advancement and use of biomaterials, regulatory barriers are created where authorities have to weigh innovation against patient safety. The review discusses the regulation of sensor-based medical devices in India, Canada, and Australia concerning market trends, regulating authorities, device classification, approval timelines, pre-market submission, post-market surveillance, cybersecurity requirements, and recent developments. It emphasizes the increasing importance of biomaterials in improving sensor performance and the imperative for harmonized quality and safety standards. The review also emphasizes the importance of international regulatory harmonization and common frameworks for the incorporation of sensor technology into biomaterial-based products, digital medicine, and AI-based compliance systems. By balancing innovation and patient protection, this review is highly beneficial to manufacturers, researchers, and healthcare professionals for improving their performance in the ever-changing regulatory environment.