Classification

Accurate and accountable Medical Device Classification is crucial for a successfully regulated and registered Medical Device.

The medical devices regulatory framework has a classification system for medical devices and IVDs, as per the regulations of Act 101 of 1965.

A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in the Classification Rules for Medical Devices.

An IVD medical device has the medical device classification applying under the classification rules set out in the Classification Rules for IVDs.

ClassificationLevel of risk
Class ALow risk
Class BLow–moderate risk
Class CModerate – high risk
Class DHigh risk
Where risk relates to the patient or to public health