A series of documents that provide communication to the industry and interested stakeholders on the regulatory requirements and processes that have been implemented by SAHPRA to supported expedited processing of applications for medical devices and IVDs during the COVID-19 pandemic.
These documents can be found on the SAHPRA website under communications to industry (at the bottom) on the medical device page and on the dedicated COVID-19 page under medical devices.
- UPDATED! MD001 Regulatory Requirements for Medical Devices COVID-19 – Version 2
- Updated 22/07/2020
- UPDATED! MD002 Regulatory Requirements for Serological Test Kits – Version 2 Updated22/07/2020
- NEW! MD003 Testing for COVID-19 – Version 1 22/07/2020
- MD004 EXTENSION – Use of Acknowledgement Letter in Lieu of Licence – Version 131/03/2020
- NEW! MD005 Expedited Regulatory Pathways for Medical Devices – Version 1 22/07/2020
- NEW! MD006 Laboratory Testing and Use of COVID-19 Serological Test Kits – Version 1 22/07/2020
- UPDATED! MD007 Specifications Serological Test kits – Version 2 Updated 22/07/2020
- NEW! MD008 ISO Standards for Medical Devices and Protective Clothing – Version 1 22/07/2020
- MD009 Alternative Regulatory Licensing Requirements Alcohol-based sanitisers – Version 103/07/2020
- MD010 Guidance Rapidly-developed-ventilators – Version 1 26/05/2020
- NEW! MD011 Licence Conditions for COVID-19 Serological Test Kits – Version 1 22/07/2020
- NEW! MD012 Notice of Contravention of Act 101 of 1965 – Version 1 22/07/2020
- NEW! MD013 Process Flow Locally Manufactured COVID-19 Test Kits – Version 1 22/07/2020
- NEW! MD014 Regulatory Requirements for Molecular Test Kits – Version 1 22/07/2020
- NEW! MD015 Process Flow Imported COVID-19 Test Kits – Version 1 22/07/2020
- NEW! MD016 Conditions of Use COVID-19 Serological Test Kits – Version 1 22/07/2020
- NEW! D017 Technical Review Application COVID-19 Molecular Test Kits – Version 122/07/2020
- NEW! MD018 Specifications Molecular Test kits – Version 1 22/07/2020
