Digital Health Companies Alert: AI Medical Software Must Meet Clinical Validation, Quality Management, and Surveillance Standards

The Minister of Health has stipulated Decree No. HK.01.07/MENKES/951/2026 on Guidelines for Marketing Authorization of Software-Based Medical Devices (“Decree 951/2026”). The Decree requires medical device manufacturers to implement a quality management system adapted to the software lifecycle and conduct local clinical validation for algorithm-based devices before placing the products on the market.[1]

Companies operating in the digital health sector must comply with Good Machine Learning Practices (“GMLP”) and ensure that their systems are interoperable with the National Health Information System (“SIKN”).[2] Developers are also required to establish continuous post-market surveillance protocols to monitor algorithmic anomalies and cybersecurity vulnerabilities.[3]