MEDICAL DEVICES AND IN VITRO DIAGNOSTICS COMMUNICATION TO INDUSTRY

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
5.08Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs,

2020 Apr

3Downloadcommunication-to-industry guidelinemedical-devices
MD004Extension – Use of acknowledgement letter in lieu of a licence,

2020 Mar

1pdfDownloadcommunication-to-industry guidelinemedical-devices
MD010Guidance Rapidly developed ventilator,

2020 May

1pdfDownloadcommunication-to-industry guidelinemedical-devices
MD001Regulatory Requirements for Medical Devices COVID-19

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD002Regulatory Requirements for Serological Test Kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD003Testing for COVID-19

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD005Expedited Regulatory Pathways for Medical Devices

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD007Specifications Serological Test kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD008ISO Standards for Medical Devices and Protective Clothing

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD009Alternative Regulatory Licensing Requirements Alcohol-based sanitisers

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD011Licence Conditions for COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD012Notice of Contravention of Act 101 of 1965

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD013Process Flow Locally Manufactured COVID-19 Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD014Regulatory Requirements for Molecular Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD015Process Flow Imported COVID-19 Test Kits

2022 Mar

2pdfDownloadcommunication-to-industrymedical-devices
MD016Conditions of Use COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD017Technical Review Application COVID-19 Molecular Test

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD018Specifications Molecular Test kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD019Processing of licence applications

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD020Certificate of Free Sale

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD021Use SARS CoV-2 Antibody Tests NDOH

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
MD022Application Clinical Evaluation Medical Device IVD

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD025Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD025Alternative licensing and regulatory pathway for masks

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD027Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)

2021 Mar

1docxDownloadcommunication-to-industrymedical-devices
MD028Communication Retention Fees

2021 May

1pdfDownloadcommunication-to-industrymedical-devices
MD029Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

2021 Jun

1pdfDownloadcommunication-to-industrymedical-devices
8.04Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs

2021 Dec

1pdfDownloadcommunication-to-industrymedical-devices
Communication to Industry Licence Acknowledgement Letter,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Amendment,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
Reprocessing of Single Use Medical Devices Communication to Stakeholders,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
2.32Wound Dressings,

2011 Nov

1Downloadcommunication-to-industry position-statementmedical-devices
9.103Tissue Engineering Products,

2017 Nov

1Downloadcommunication-to-industry position-statementmedical-devices
9.105Section 21 Authorisation of Sale Unregistered Medical Devices,

2017 Nov

1, , , Downloadcommunication-to-industry position-statementemergency-use medical-devices section-21 unregistered-products
9.106Class A Medical Devices,

2017 Sep

1Downloadcommunication-to-industry position-statementmedical-devices
9.78Disinfectants Status of Antiseptics and Germicides,

2016 Jul

1Downloadcommunication-to-industry position-statementmedical-devices
9.79Medical Device Establishments: License Requirements,

2016 Sep

1Downloadcommunication-to-industry position-statementmedical-devices
9.96Transitional Arrangements for Medical Devices,

2017 Apr

1Downloadcommunication-to-industry position-statementmedical-devices
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

2022 Feb

1pdfDownloadcommunication-to-industrymedical-devices
MD031Medical Device Establishment Licence Renewal Process

2022 Sep

2pdfDownloadcommunication-to-industrymedical-devices
Upcoming SAHPRA and Industry workshop

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders with regards to the current status of the Medical Device Regulations

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
MD032ISO 13485 Conformity Assessment Body Communication

2022 Aug

2pdfDownloadcommunication-to-industrymedical-devices
MD034Conditions for use of COVID-19 antigen self-test kits

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
MD035Usability studies for Covid-19 self-testing kits requirements

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
Conformity assessment body(cab) requirements for recognition by Sahpra checklist,

2022 Mar

1pdfDownloadchecklist communication-to-industrymedical-devices
Conformity of assessment body DoC template,

2022 Mar

1docxDownloadcommunication-to-industry templatesmedical-devices
MD033Specification criteria for COVID-19 rapid antigen selftests

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
Retention Fee Notification – 9 June 2022

2022 Jun

1, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
MD036COVID-19 Test Kits Batch Verification

2022 Jun

1wwwDownloadcommunication-to-industrymedical-devices
MD037Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

2022 Jul

1pdfDownloadcommunication-to-industrymedical-devices