Articles

This guidance provides specific information on the clinical evidence requirements for the following types of devices:

  • Total and partial joint prostheses
  • Cardiovascular devices to promote patency or functional flow
  • Implantable pulse generators
  • Heart valve prostheses
  • Supportive devices – meshes, patches, and tissue adhesives
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South African Health Products Regulatory Authority (SAHPRA) regulates medicines, scheduled
substances and medical devices for human and animal use, on behalf of the Department of Health and
in accordance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of
1965) and the relevant Regulations made thereunder. (Hereafter referred to as the Act or the
Medicines Act.)

This guideline describes the following points;

  • Manufacture And Packaging
  • Exemptions From A Licence To Manufacture, Import Or Export
  • How To Obtain A Licence Application Form And Information To Submit
  • Manufacturers’ Obligations
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The aim of this Guideline is to assist wholesalers in the preparation of documentation for the application
to be licensed to export medicinal products Whenever there is doubt, wholesalers are advised to consult
South African Health Products Regulatory Authority (SAHPRA) for confirmation and/or clarification before
completing and submitting an application.

This guideline applies to all wholesalers who are intending to export medicinal products.

this guideline describes the following points;

  • Quality Management Systems
  • Requirements to be met By The Wholesaler Intending To Export
  • Requirements To Be Met By The HCR
  • Requirements To Be Met By The Foreign Site
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A rapidly developed invasive or non-invasive ventilator classified as a Class C medical device in terms of the Medicines Act must comply with the latest version of the above referenced WHO specification (refer clause 6) and Appendix B of the MHRA specifications (refer clause 7), with adaptations in line with relevant South African legislation and standards, for purposes of emergency use during the Covid-19 pandemic in South Africa.

This guideline describes the following points;

  • Current Medical Device Licence and Regulatory Process
  • Hazardous Substances Act
  • Minimum Regulatory and Licensing Requirements for a manufacturer or distributor of a rapidly
    developed ventilator for emergency use during the Covid-19 pandemic
  • License Application Process and Timelines
  • Local manufacturers of invasive or non-invasive ventilators
  • Conditions of Licence and Authorisation for use of unregistered ventilators
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