HONG KONG SAR, CHINA Law and Practice Contributed by: Gordon Chan
Strengthening Medical Device Oversight One major area of development centres on medical devices. The Department of Health plans to establish the Hong Kong Centre for Medical Products Regula - tion by the end of 2026. This independent body will build on the existing MDACS, moving from its current voluntary listing approach to a full statutory registra - tion regime. The reform introduces stronger pre-mar - ket checks and ongoing surveillance to ensure devic - es meet rigorous safety and quality requirements. It also supports faster access to new medical products through a primary evaluation system based on local assessments.
Addressing New Technologies Policymakers are also turning their attention to digital and smart products. A new Protection of Critical Infra - structures (Computer Systems) Ordinance (Cap 653) came into effect on 1 January 2026, while updated guidance on artificial intelligence promotes respon - sible development and use. These initiatives may influence how liability applies to software, Internet of Things devices, and AI-powered items in the future. Overall, the emphasis remains on practical, risk-based improvements that balance consumer protection with business growth.
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