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MEDICAL DEVICES AND IN VITRO DIAGNOSTICS COMMUNICATION TO INDUSTRY

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
MD01-2023/24Mpox Diagnostic Tests13/09/20241pdfDownloadcommunication-to-industrymedical-devices
MD01-2024/2025Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders09/07/20241pdfDownloadcommunication-to-industrymedical-devices
Expression of Interest for Medical Device Registration Voluntary Feasibility Study17/05/20241pdfDownloadcommunication-to-industrymedical-devices
MD038SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/74602/10/20231, pdfDownloadcommunication-to-industrymedical-devices radiation-control
MD037Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators22/07/20221pdfDownloadcommunication-to-industrymedical-devices
MD036COVID-19 Test Kits Batch Verification16/06/20221wwwDownloadcommunication-to-industrymedical-devices
Retention Fee Notification – 9 June 202224/06/20221, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
MD033Specification criteria for COVID-19 rapid antigen selftests18/03/20221pdfDownloadcommunication-to-industrymedical-devices
Conformity of assessment body DoC template, 30/03/20221docxDownloadcommunication-to-industry templatesmedical-devices
Conformity assessment body(cab) requirements for recognition by Sahpra checklist, 24/03/20221pdfDownloadchecklist communication-to-industrymedical-devices
MD035Usability studies for Covid-19 self-testing kits requirements24/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD034Conditions for use of COVID-19 antigen self-test kits17/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD032ISO 13485 Conformity Assessment Body Communication19/08/20222pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders with regards to the current status of the Medical Device Regulations23/03/20221pdfDownloadcommunication-to-industrymedical-devices
Upcoming SAHPRA and Industry workshop17/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD031Medical Device Establishment Licence Renewal Process22/09/20222pdfDownloadcommunication-to-industrymedical-devices
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication02/02/20221pdfDownloadcommunication-to-industrymedical-devices
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
Reprocessing of Single Use Medical Devices Communication to Stakeholders, 20/11/20191pdfDownloadcommunication-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
MD029Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators24/06/20211pdfDownloadcommunication-to-industrymedical-devices
MD028Communication Retention Fees27/05/20211pdfDownloadcommunication-to-industrymedical-devices
MD027Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)12/03/20211docxDownloadcommunication-to-industrymedical-devices
MD025Alternative licensing and regulatory pathway for masks24/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD025Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-1922/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits19/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD022Application Clinical Evaluation Medical Device IVD19/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD021Use SARS CoV-2 Antibody Tests NDOH13/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD020Certificate of Free Sale03/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD019Processing of licence applications16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD018Specifications Molecular Test kits23/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD017Technical Review Application COVID-19 Molecular Test15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD016Conditions of Use COVID-19 Serological Test Kits16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD015Process Flow Imported COVID-19 Test Kits17/03/20222pdfDownloadcommunication-to-industrymedical-devices
MD014Regulatory Requirements for Molecular Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD013Process Flow Locally Manufactured COVID-19 Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD012Notice of Contravention of Act 101 of 196531/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD011Licence Conditions for COVID-19 Serological Test Kits15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD009Alternative Regulatory Licensing Requirements Alcohol-based sanitisers17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD008ISO Standards for Medical Devices and Protective Clothing16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD007Specifications Serological Test kits14/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits09/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD005Expedited Regulatory Pathways for Medical Devices16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD003Testing for COVID-1909/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD002Regulatory Requirements for Serological Test Kits17/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD001Regulatory Requirements for Medical Devices COVID-1916/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD010Guidance Rapidly developed ventilator13/05/20201pdfDownloadcommunication-to-industrymedical-devices
MD004Extension – Use of acknowledgement letter in lieu of a licence05/03/20201pdfDownloadcommunication-to-industrymedical-devices