| 5.08 | Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs | Communication to industry, Guideline | 2020 Apr
| 3 | Medical Devices | pdf | Download | communication-to-industry guideline | medical-devices |
| 004 | MD004 – Extension – Use of acknowledgement letter in lieu of a licence | Communication to industry, Guideline | 2020 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry guideline | medical-devices |
| 010 | MD010 – Guidance Rapidly developed ventilator | Communication to industry, Guideline | 2020 May
| 1 | Medical Devices | pdf | Download | communication-to-industry guideline | medical-devices |
| 001 | MD001 – Regulatory Requirements for Medical Devices COVID-19 | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 002 | MD002 – Regulatory Requirements for Serological Test Kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 003 | MD003 – Testing for COVID-19 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 005 | MD005 – Expedited Regulatory Pathways for Medical Devices | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 006 | MD006 – Laboratory Testing and Use of COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 007 | MD007 – Specifications Serological Test kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 008 | MD008 – ISO Standards for Medical Devices and Protective Clothing | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 009 | MD009 – Alternative_Regulatory_Licensing_Requirements_Alcohol-based_sanitisers | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 011 | MD011 – Licence Conditions for COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 012 | MD012 – Notice of Contravention of Act 101 of 1965 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 013 | MD013 – Process Flow Locally Manufactured COVID-19 Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 014 | MD014 – Regulatory Requirements for Molecular Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 015 | MD015 – Process Flow Imported COVID-19 Test Kits | Communication to industry | 2022 Mar
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 016 | MD016 – Conditions of Use COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 017 | MD017 – Technical Review Application COVID-19 Molecular Test | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 018 | MD018 – Specifications Molecular Test kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 019 | MD019 – Processing of licence applications | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 020 | MD020 – Certificate of Free Sale | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 021 | MD021 – Use SARS CoV-2 Antibody Tests NDOH | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 022 | MD022 – Application_Clinical_Evaluation_Medical_Device_IVD | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 024 | MD024 – Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 025 | MD025 – Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 025 | MD025 – Alternative licensing and regulatory pathway for masks | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 027 | MD027 – Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs) | Communication to industry | 2021 Mar
| 1 | Medical Devices | docx | Download | communication-to-industry | medical-devices |
| 028 | MD028 – Communication Retention Fees | Communication to industry | 2021 May
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 029 | MD029 – Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 2021 Jun
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 8.04 | Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs | Communication to industry | 2021 Dec
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Communication to Industry Licence Acknowledgement Letter | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Communication to Industry Licence Amendment | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Reprocessing of Single Use Medical Devices Communication to Stakeholders | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 2.32 | Wound Dressings | Communication to industry, Position statement | 2011 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.103 | Tissue Engineering Products | Communication to industry, Position statement | 2017 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.105 | Section 21 Authorisation of Sale Unregistered Medical Devices | Communication to industry, Position statement | 2017 Nov
| 1 | Medical Devices, Section 21, Unregistered products | pdf | Download | communication-to-industry position-statement | medical-devices section-21 unregistered-products |
| 9.106 | Class A Medical Devices | Communication to industry, Position statement | 2017 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.78 | Disinfectants Status of Antiseptics and Germicides | Communication to industry, Position statement | 2016 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.79 | Medical Device Establishments: License Requirements | Communication to industry, Position statement | 2016 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.96 | Transitional Arrangements for Medical Devices | Communication to industry, Position statement | 2017 Apr
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 030 | MD030 – Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication | Communication to industry | 2022 Feb
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 031 | MD031 – Medical Device Establishment Licence Renewal Process | Communication to industry | 2022 Feb
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Upcoming SAHPRA and Industry workshop | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Communication to Stakeholders with regards to the current status of the Medical Device Regulations | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 032 | MD032: ISO 13485 Conformity Assessment Body Communication | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 034 | MD034: Conditions for use of COVID-19 antigen self-test kits | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 035 | MD035: Usability studies for Covid-19 self-testing kits requirements | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Conformity assessment body(cab) requirements for recognition by Sahpra checklist | Communication to industry, Form | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry form | medical-devices |
| Conformity of assessment body DoC template | Communication to industry, Templates | 2022 Mar
| 1 | Medical Devices | docx | Download | communication-to-industry templates | medical-devices |
| 033 | MD033: Specification criteria for COVID-19 rapid antigen selftests | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Retention Fee Notification – 9 June 2022 | Communication to industry | June 2022
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Inspectorate and good manufacturing practices, Medical Devices | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices |
