Navigating Innovation, Safety, and Regulation: A Scoping Review of Global Regulatory Challenges in New-Age Technology Based Medical Devices

The rapid advances in medical device technologies, such as artificial intelligence, machine learning, IoMT, wearable devices, blockchain, mobile medical applications, and three-dimensional printing, have transformed healthcare delivery. These new-age technology based medical devices are also getting increasingly software-driven, adaptive, and interconnected; this creates regulatory complexities from device classification to clinical evaluation and cybersecurity to post-market surveillance across the product lifecycle. However, global regulatory authorities have provided frameworks and guidance to meet these challenges; yet, the variation of regulatory approaches, lack of harmonization, and -higher-order evolving technological capabilities are repeatedly widening gaps in effective oversight. The available literature remains fragmented across regulatory, technical, and policy domains. A scoping review is thus indicated to systematically map the available evidence, identify the key regulatory challenges, and outline the gaps and needs for further research.