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

3pdfDownloadcommunication-to-industry guidelinemedical-devices
004MD004 – Extension – Use of acknowledgement letter in lieu of a licence,

2020 Mar

1pdfDownloadcommunication-to-industry guidelinemedical-devices
010MD010 – Guidance Rapidly developed ventilator,

2020 May

1pdfDownloadcommunication-to-industry guidelinemedical-devices
001MD001 – Regulatory Requirements for Medical Devices COVID-19

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
002MD002 – Regulatory Requirements for Serological Test Kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
003MD003 – Testing for COVID-19

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
005MD005 – Expedited Regulatory Pathways for Medical Devices

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
006MD006 – Laboratory Testing and Use of COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
007MD007 – Specifications Serological Test kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
008MD008 – ISO Standards for Medical Devices and Protective Clothing

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
009MD009 – Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
011MD011 – Licence Conditions for COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
012MD012 – Notice of Contravention of Act 101 of 1965

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
013MD013 – Process Flow Locally Manufactured COVID-19 Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
014MD014 – Regulatory Requirements for Molecular Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
015MD015 – Process Flow Imported COVID-19 Test Kits

2022 Mar

2pdfDownloadcommunication-to-industrymedical-devices
016MD016 – Conditions of Use COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
017MD017 – Technical Review Application COVID-19 Molecular Test

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
018MD018 – Specifications Molecular Test kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
019MD019 – Processing of licence applications

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
020MD020 – Certificate of Free Sale

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
021MD021 – Use SARS CoV-2 Antibody Tests NDOH

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
022MD022 – Application_Clinical_Evaluation_Medical_Device_IVD

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
024MD024 – Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
025MD025 – Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
025MD025 – Alternative licensing and regulatory pathway for masks

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
027MD027 – Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)

2021 Mar

1docxDownloadcommunication-to-industrymedical-devices
028MD028 – Communication Retention Fees

2021 May

1pdfDownloadcommunication-to-industrymedical-devices
029MD029 – Renewal 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

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

2017 Nov

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

2017 Nov

1, , pdfDownloadcommunication-to-industry position-statementmedical-devices section-21 unregistered-products
9.106Class A Medical Devices,

2017 Sep

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

2016 Jul

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

2016 Sep

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

2017 Apr

1pdfDownloadcommunication-to-industry position-statementmedical-devices
030MD030 – Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

2022 Feb

1pdfDownloadcommunication-to-industrymedical-devices
031MD031 – Medical Device Establishment Licence Renewal Process

2022 Feb

1pdfDownloadcommunication-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
032MD032: ISO 13485 Conformity Assessment Body Communication

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
034MD034: Conditions for use of COVID-19 antigen self-test kits

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
035MD035: Usability 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

1pdfDownloadcommunication-to-industry formmedical-devices
Conformity of assessment body DoC template,

2022 Mar

1docxDownloadcommunication-to-industry templatesmedical-devices
033MD033: Specification criteria for COVID-19 rapid antigen selftests

2022 Mar

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

June 2022

1, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices