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Covid-19 SAHPRA Documents


Home  /  Covid-19 SAHPRA Documents
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
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_v2-22072020-1

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