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