Hong Kong's Mandatory Medical Device Registration Transition
📢 DDReg Knowledge Capsule – Episode [18]Hong Kong is transitioning from the Medical Device Administrative Control System (MDACS), a voluntary listing mechanism, to a new statutory mandatory registration system. This significant shift is driven by the Department of Health’s goal to strengthen patient safety and align with mature international regulatory frameworks by requiring comprehensive technical documentation and stricter vigilance. The new system will be overseen by the Centre for Medical Products Regulation (CMPR), expected to be operational by 2026, which will introduce stricter requirements for manufacturers and expand the legal accountability of Local Responsible Persons (LRPs). https://resource.ddregpharma.com/blogs/mandatory-medical-device-registration-in-hong-kong/
