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South Africa Medical Device Regulations

Agency
South African Health Products Regulatory Authority (SAHPRA) regulates medical devices in South Africa.
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
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.
Approval Process
Classification Approval procedure
Class A Class A medical devices (except those having a measuring function or which are required to be sterile) are exempted from registration.
Class B
  • An electronic application accompanying the requisite documents:
    • list of medical devices classified according to Global Medical Device Nomenclature Code (GMDN);
    • QMS information;
    • free sale certificate and;
    • certificate of conformance/analysis should be submitted to the authority.
  • After reviewing the completeness of the documents, authority will provide an approval.
Class C
  • The applicant must appoint an Authorised Representative in South Africa.
  • The application for a license to manufacture, import, or export medical devices or IVDs.
  • The applicant must provide certified evidence of certification to a Quality Management System as determined by Council.
  • A certified copy of the conformity assessment certificate is needed to comply with a quality standard as determined by the Council which is issued by a Conformity Assessment Body.
  • If approved, the medical device will be included in the Medical Device register.
Class D
Note: An Authorized representative must be appoint for foreign manufacturers.
Additional Information
Approval timeline 6-8 weeks
License validity period 5 years
Fees R25 200
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