Table 1 Medical Device Bureau classification of medical devices
MDB Class | Risk | Examples |
|---|---|---|
Class I | Lowest risk | Surgical instruments, culture media |
Class II | Low risk | Contact lenses, epidural catheters, pregnancy test kits, surgical gloves, ultrasound scanner |
Class III | Moderate risk | Orthopaedic implants, glucose monitors, dental implants, haemodialysis systems |
Class IV | High risk | HIV test kits, pacemakers, angiographic catheters |