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


Ross et al. BMC Medical Ethics 2010 11:14   doi:10.1186/1472-6939-11-14

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