HONG KONG MDD 2026 UPDATE: NEW DEFINITIONS FOR PERSONALIZED DEVICES & REPORTING

HONG KONG MDD 2026 UPDATE: NEW DEFINITIONS FOR PERSONALIZED DEVICES & REPORTING

Hong Kong MDD 2026 update on personalized medical devices and reporting

Hong Kong, January 6, 2026 —The Hong Kong Department of Health has released a significant update to the Medical Device Administrative Control System (MDACS). Effective December 31, 2025, the updated GN-00 Guidance introduces critical new definitions for personalized manufacturing, rebrands the regulatory body, and tightens safety reporting criteria. Stay Compliant: “Review the Hong Kong MDD […]

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