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. May be supplied without MDD registration.

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.