Grade I · II · III · IV — Overview
| Grade | Risk | Examples | Pre-market pathway |
|---|---|---|---|
| I | Low | Surgical gloves, gauze, tongue depressors | 품목신고 (Notification) |
| II | Low–medium | Electronic BP monitors, syringes, basic diagnostic equipment | 품목신고 (Notification) |
| III | Medium–high | Haemodialysis equipment, orthopaedic implants, ventilators | 품목허가 (Authorization) |
| IV | High | Cardiac pacemakers, coronary stents, implantable defibrillators | 품목허가 (Authorization) |
Grade I — Low risk
Non-invasive devices with minimal potential for harm. Pathway: 품목신고 processed in ~1–3 weeks.
Grade II — Low-medium risk
Active devices with limited body contact or non-implantable sterile devices. Pathway: 품목신고.
Grade III — Medium-high risk
Devices sustaining or supporting life with higher harm potential. Pathway: 품목허가 (full MFDS review ~3–6 months). Requires comprehensive technical documentation and usually clinical data.
Grade IV — High risk
Life-sustaining or life-critical implantables. Pathway: 품목허가 with the most rigorous review (~6–12 months). Mandatory clinical data and GMP certification.
Relevant legislation
- Medical Devices Act, Article 2 (Grade definitions)