MEDICAL DEVICES AND IN VITRO DIAGNOSTICS COMUNICATION TO INDUSTRY

NumberFile NameYearVersionDocument TypeDownload
List of Approved Antigen tests20212Communication to industry
List of authorised Molecular Test20202Communication to industry
List of authorised serological Test Kits20212Communication to industry
List of authorised mask establishments2020Communication to industry
MD001Regulatory Requirements for Medical Devices COVID-1920202Communication to industry
MD002Regulatory Requirements for Serological Test Kits20202Communication to industry
MD003Testing for COVID-1920201Communication to industry
MD004EXTENSION – Use of Acknowledgement Letter in Lieu of Licence20201Communication to industry
MD005Expedited Regulatory Pathways for Medical Devices20201Communication to industry
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits20201Communication to industry
MD007Specifications Serological Test kits20202Communication to industry
MD008ISO Standards for Medical Devices and Protective Clothing20201Communication to industry
MD009Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers20201Communication to industry
MD010Regulatory Requirements, Technical Specifications, Licence Conditions and Authorisation for Use of Unregistered Rapidly Developed Invasive and Non-Invasive Ventilators for Covid-1920201Communication to industry
MD011Licence Conditions for COVID-19 Serological Test Kits20201Communication to industry
MD012Notice of Contravention of Act 101 of 196520201Communication to industry
MD013Process Flow Locally Manufactured COVID-19 Test Kits20201Communication to industry
MD014Regulatory Requirements for Molecular Test Kits20201Communication to industry
MD015Process Flow Imported COVID-19 Test Kits20201Communication to industry
MD016Conditions of Use COVID-19 Serological Test Kits20201Communication to industry
MD017Technical Review Application COVID-19 Molecular Test20201Communication to industry
MD018Specifications Molecular Test kits20202Communication to industry
MD019Processing of licence applications20201Communication to industry
MD020Certificate of Free Sale20201Communication to industry
MD021Use SARS CoV-2 Antibody Tests NDOH20201Communication to industry
MD022Application_Clinical_Evaluation_Medical_Device_IVD20201Communication to industry
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits20201Communication to industry
MD025Alternative licensing and regulatory pathway for masks20201Communication to industry
MD025Licensing and Regulatory requirements for the manufacture and
distribution of medical and respirator masks during Covid-19
20201Communication to industry