Medical Device Definition
A medical device in South Africa is any instrument, appliance, material, machine, apparatus, implant, or diagnostic reagent-
- used or purporting to be suitable for use or manufactured or sold for use in
- the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or
- restoring, correcting or modifying any somatic or psychic or organic function; or;
- the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or
- declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device.
Medical Device Classification System
||Bandages and basic wound dressings.
||Powered wheelchairs and electrotherapy devices.
||Moderate – high risk
||Diagnostic X-ray equipment and implantable hearing aids.
||Implantable heart pacemakers and insulin pumps.
|License validity period