To ensure reliability, safety, and ethical deployment, the robot is built to globally recognised standards and fully complies with IEC 63310, ISO 13482, and ISO 14485, which certify its performance, safety, and suitability for real-world eldercare environments.
As part of the development roadmap, the robot will undergo rigorous functionality trials and pilot programs with Singapore hospitals and public institutions. These initiatives will ensure compliance with Health Sciences Authority (HSA) regulations, and refine its capabilities for real-world deployment.
In a landmark regulatory milestone, the robot has successfully completed its HSA Class A medical device notification (Notification No. MDPN260129A0030, listed 29 January 2026).
This covers, under a single platform, core functions including physiological health monitoring, fall detection, companionship communication, medication management, sleep monitoring and harmful gas detection.
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“To the best of our knowledge, this makes AJJ Medtech and Huaxi Intelligent the first in the world to achieve formal medical device regulatory notification for a multifunctional embodied humanoid eldercare robot under major global regulatory frameworks, including HSA, U.S. FDA, and EU CE (MDR),” the company shares.
In addition, to uphold ethical standards in AI and eldercare, all medical data collected and device integration conducted by the robot will fully comply with the Personal Data Protection Act (“PDPA”).
Beyond relieving workforce shortages, AJJ Medtech believes that the robot offers a practical and scalable solution for the growing demands of an ageing population.
AJJ Medtech’s board shares that regulatory approval, intellectual property considerations and market volatility may affect the project’s timeline, cost and commercial success.
As at 10.12am, shares in AJJ Medtech are trading flat at 0.9 cents.
