| 5.08 | Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs | Communication to industry, Guideline | 2020 Apr
| 3 | Medical Devices | | Download | communication-to-industry guideline | medical-devices |
| 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 |
| MD010 | Guidance Rapidly developed ventilator | Communication to industry, Guideline | 2020 May
| 1 | Medical Devices | pdf | Download | communication-to-industry guideline | medical-devices |
| MD001 | Regulatory Requirements for Medical Devices COVID-19 | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD002 | Regulatory Requirements for Serological Test Kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD003 | Testing for COVID-19 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD005 | Expedited Regulatory Pathways for Medical Devices | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 |
| MD007 | Specifications Serological Test kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD008 | ISO Standards for Medical Devices and Protective Clothing | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD009 | Alternative Regulatory Licensing Requirements Alcohol-based sanitisers | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD011 | Licence Conditions for COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD012 | Notice of Contravention of Act 101 of 1965 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD013 | Process Flow Locally Manufactured COVID-19 Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD014 | Regulatory Requirements for Molecular Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD015 | Process Flow Imported COVID-19 Test Kits | Communication to industry | 2022 Mar
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD016 | Conditions of Use COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD017 | Technical Review Application COVID-19 Molecular Test | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD018 | Specifications Molecular Test kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD019 | Processing of licence applications | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD020 | Certificate of Free Sale | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD021 | Use SARS CoV-2 Antibody Tests NDOH | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD022 | Application Clinical Evaluation Medical Device IVD | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 |
| 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 |
| MD025 | Alternative licensing and regulatory pathway for masks | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 |
| MD028 | Communication Retention Fees | Communication to industry | 2021 May
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 | | Download | communication-to-industry position-statement | medical-devices |
| 9.103 | Tissue Engineering Products | Communication to industry, Position statement | 2017 Nov
| 1 | Medical Devices | | 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 | Emergency use, Medical Devices, Section 21, Unregistered products | | Download | communication-to-industry position-statement | emergency-use medical-devices section-21 unregistered-products |
| 9.106 | Class A Medical Devices | Communication to industry, Position statement | 2017 Sep
| 1 | Medical Devices | | 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 | | 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 | | 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 | | Download | communication-to-industry position-statement | medical-devices |
| MD030 | Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication | Communication to industry | 2022 Feb
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD031 | Medical Device Establishment Licence Renewal Process | Communication to industry | 2022 Sep
| 2 | 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 |
| MD032 | ISO 13485 Conformity Assessment Body Communication | Communication to industry | 2022 Aug
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 |
| 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 | Checklist, Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | checklist communication-to-industry | 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 |
| 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 | 2022 Jun
| 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 |
| MD036 | COVID-19 Test Kits Batch Verification | Communication to industry | 2022 Jun
| 1 | Medical Devices | www | Download | communication-to-industry | medical-devices |
| MD037 | Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 2022 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
