- Joint communication from SAHPRA, NRCS and SABS on the regulatory status of products used for the prevention of Covid-19.
- Guidance to companies applying for an establishment license or amendment in relation to COVID-19 products – fast track process
- MD001-Regulatory-Requirements-for-Medical-Devices-COVID-19-v2-22072020
- MD002-Regulatory-Requirements-for-Serological-Test-Kits-v2-22072020
- MD003-Testing-for-COVID-19-v1-22072020
- MD004-EXTENSION-Use-of-Acknowledgement-Letter-in-Lieu-of-Licence-v1-31032020
- MD005-Expedited-Regulatory-Pathways-for-Medical-Devices-v1-22072020
- MD006-Laboratory-Testing-and-Use-of-COVID-19-Serological-Test-Kits-v1-22072020
- MD007-Specifications-Serological-Test-kits-v2-22072020
- MD008-ISO-Standards-for-Medical-Devices-and-Protective-Clothing-v1-22072020
- MD009-Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers-v1-03072020
- MD010_Guidance_Rapidly-developed-ventilators_v1-26052020
- MD011-Licence-Conditions-for-COVID-19-Serological-Test-Kits-v1-22072020
- MD012-Notice-of-Contravention-of-Act-101-of-1965-v1-22072020
- MD013-Process-Flow-Locally-Manufactured-COVID-19-Test-Kits-v1-22072020
- MD014-Regulatory-Requirements-for-Molecular-Test-Kits-v1-22072020
- MD015-Process-Flow-Imported-COVID-19-Test-Kits-v1-22072020
- MD016-Conditions-of-Use-COVID-19-Serological-Test-Kits-v1-22072020
- MD017-Technical-Review-Application-COVID-19-Molecular-Test-Kits-v1-22072020
- MD018-Specifications-Molecular-Test-kits-v1-22072020
- MD019-Processing-of-licence-applications-v1-22072020
- MD020-Certificate of Free Sale v2 2272020
Please consult the SAHPRA website for any new documents.
