Position Statements

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
CEO04Policy Position of the South African Health Products Regulatory Authority on Enabling Local Manufacturing09/07/20251pdfDownloadposition-statementcorporate
9.96Transitional Arrangements for Medical Devices, 27/04/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.79Medical Device Establishments: License Requirements, 21/09/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.78Disinfectants Status of Antiseptics and Germicides, 21/07/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.106Class A Medical Devices, 14/09/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.105Section 21 Authorisation of Sale Unregistered Medical Devices, 16/11/20171, , , pdfDownloadcommunication-to-industry position-statementemergency-use medical-devices section-21 unregistered-products
9.103Tissue Engineering Products, 16/11/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
2.32Wound Dressings, 23/11/20111pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Amendment, 27/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Acknowledgement Letter, 28/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices