Class I · II · III · IV — General Medical Devices

Class I — Low Risk

Examples: Bandages, tongue depressors, examination gloves, stethoscopes, non-sterile gauze
MDACS: ❌ Not eligible for listing. Class I devices fall outside the MDACS framework. They may be supplied without MDACS registration but must still comply with general safety and quality standards under Hong Kong law.

Class II — Moderate-Low Risk

Examples: Hypodermic needles, suction equipment, diagnostic imaging software, patient monitoring devices
MDACS: ✅ Eligible. Subject to DH Stage C procurement mandate from March 2026.

Class III — Moderate-High Risk

Examples: Lung ventilators, bone fixation plates, dialysis machines, implantable insulin pumps
MDACS: ✅ Eligible. Higher documentation burden; ISO 13485 and clinical evaluation required.

Class IV — High Risk

Examples: Heart valves, pacemakers, implantable defibrillators, cochlear implants, total joint replacements
MDACS: ✅ Eligible. Most stringent requirements. Expedited reliance scheme is especially valuable given comprehensive reference-country dossiers typically available.

Class I — Low Risk

Examples: Bandages, tongue depressors, examination gloves, stethoscopes, non-sterile gauze

MDacs: ❌ Not eligible for listing. These devices fall outside the MDACS framework and may be supplied without MDD registration, provided they comply with general safety and quality obligations under Hong Kong law.