South Africa Medical Device Regulations

Regulatory Agency

South African Health Products Regulatory Authority (SAHPRA) regulates medical devices in South Africa.

Medical Device Definition

Medical Device: means any instrument, appliance, material, machine, apparatus, implant, or diagnostic reagent-
(a) Used or purporting to be suitable for use or manufactured or sold for use in -
(i) The diagnosis, treatment, mitigation, modification, monitoring, or prevention of disease, abnormal physical or mental states or the symptoms thereof; or
(ii) Restoring, correcting, or modifying any somatic or psychic or organic function; or
(iii) 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
(b) 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

Active Medical Device: means any medical device of which the operation depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this to energy but excluding medical devices intended to transmit energy, substances or other elements between an active medical device and the user, without any significant change in the energy, substance or other element being transmitted.

Medical Device Classification System

International Classification	Risk Level	Examples
Class A	Low risk	Bandages and basic wound dressings.
Class B	Low–moderate risk	Powered wheelchairs and electrotherapy devices.
Class C	Moderate – high risk	Diagnostic X-ray equipment and implantable hearing aids.
Class D	High risk	Implantable heart pacemakers and insulin pumps.

Regulatory Approval Process

Classification	Approval process
Class A
Class B	ALL CLASSES: - Application will be sent to mdadmin@Sahpra.org.za and referred to admin team - Documents will be screened to confirm all requirements are met - Application acknowledged and referred to technical team - Application is evaluated - Application is recommended for approval - Notification letter issued - License fee should be paid - License is issued
Class C
Class D
Note: An Authorized representative must be appointed for foreign manufacturers.