| Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs | 2022 | 1 | Communication to industry | Download PDF | |
| MD029 | Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | 2021 | 1 | Communication to industry | Download |
| MD028 | Communication Retention Fees | 2021 | 1 | Communication to industry | Download |
| MD027 | Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs) | 2021 | 1 | Communication to industry | Download |
| MD025 | Alternative licensing and regulatory pathway for masks | 2020 | 1 | Communication to industry | Download PDF |
| MD025 | Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 | 2020 | 1 | Communication to industry | Download PDF |
| MD024 | Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits | 2020 | 1 | Communication to industry | Download PDF |
| MD022 | Application_Clinical_Evaluation_Medical_Device_IVD | 2020 | 1 | Communication to industry | Download PDF |
| MD021 | Use SARS CoV-2 Antibody Tests NDOH | 2020 | 1 | Communication to industry | Download PDF |
| MD020 | Certificate of Free Sale | 2020 | 1 | Communication to industry | Download PDF |
| MD019 | Processing of licence applications | 2020 | 1 | Communication to industry | Download PDF |
| MD018 | Specifications Molecular Test kits | 2020 | 2 | Communication to industry | Download PDF |
| MD017 | Technical Review Application COVID-19 Molecular Test | 2020 | 1 | Communication to industry | Download PDF |
| MD016 | Conditions of Use COVID-19 Serological Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD015 | Process Flow Imported COVID-19 Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD014 | Regulatory Requirements for Molecular Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD013 | Process Flow Locally Manufactured COVID-19 Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD012 | Notice of Contravention of Act 101 of 1965 | 2020 | 1 | Communication to industry | Download PDF |
| MD011 | Licence Conditions for COVID-19 Serological Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD010 | Regulatory Requirements, Technical Specifications, Licence Conditions and Authorisation for Use of Unregistered Rapidly Developed Invasive and Non-Invasive Ventilators for Covid-19 | 2020 | 1 | Communication to industry | Download PDF |
| MD009 | Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers | 2020 | 1 | Communication to industry | Download PDF |
| MD008 | ISO Standards for Medical Devices and Protective Clothing | 2020 | 1 | Communication to industry | Download PDF |
| MD007 | Specifications Serological Test kits | 2020 | 2 | Communication to industry | Download PDF |
| MD006 | Laboratory Testing and Use of COVID-19 Serological Test Kits | 2020 | 1 | Communication to industry | Download PDF |
| MD005 | Expedited Regulatory Pathways for Medical Devices | 2020 | 1 | Communication to industry | Download PDF |
| MD004 | EXTENSION – Use of Acknowledgement Letter in Lieu of Licence | 2020 | 1 | Communication to industry | Download PDF |
| MD003 | Testing for COVID-19 | 2020 | 1 | Communication to industry | Download PDF |
| MD002 | Regulatory Requirements for Serological Test Kits | 2020 | 2 | Communication to industry | Download PDF |
| MD001 | Regulatory Requirements for Medical Devices COVID-19 | 2020 | 2 | Communication to industry | Download PDF |