SAHPRA Publishes Consolidated Communication List for Medical Devices and IVDs

SAHPRA publishes consolidated communication list for medical devices and IVDs

On 25 June 2026, the South African Health Products Regulatory Authority (SAHPRA) updated the communication-to-industry page for medical devices and in vitro diagnostics (IVDs). The page consolidates more than 60 industry communication documents issued since 2020, covering topics such as devices for research use only, electronic instructions for use, licensing of outsourced or contracted activities, and the regulation of artificial intelligence / machine learning (AI/ML)-enabled medical devices. It provides medical device manufacturers with a comprehensive reference list of regulatory guidance.

This article is compiled from public information published by SAHPRA. Source: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-comunication-to-industry/. Specific requirements remain subject to the latest official publications of the regulatory authority.

Core content: documents included in the consolidated list

The consolidated page lists each communication by file number, title, category, date, revision, version, business unit and download link. The most recent documents in the 2026/27 cycle are summarised below.

2026/27 communications

• MD04-2026/27 (24 June 2026) - Contact details for Guideline SAHPGL-MD-03: Medical Device Vigilance: Adverse Event Reporting by Licence Holders
• MD01-2026/27 (25 June 2026) - Communication on Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including IVDs
• MD03-2026/27 (8 May 2026) - Regulatory requirements for electronic instructions for use (e-IFU) for medical devices
• MD02-2026/27 (10 April 2026) - Licensing requirements for outsourced or contracted activities by medical device establishments
• Medical Device Registration Feasibility Study Report (31 March 2026)
• MD11-2025/26 (25 March 2026) - Applications for the importation of medical devices for personal use
• MD09-2025/26 (27 January 2026) - Notification of updates to the product list on a medical device establishment licence
• MD10-2025/26 (27 January 2026) - Amendments to medical device establishment licences

2025/26 communications

• CRO01-2025/26 (18 November 2025) - Core business upgrade procedure (applies across biological medicines, clinical evaluation management, clinical trials, complementary medicines, inspections, licensing, medical devices, medicine evaluation management, radiation control, regulatory compliance, Section 21 and veterinary medicines)
• MD01-2025/2026 (22 September 2025) - ISO 13485 certification as a prerequisite for medical device establishment licence approval
• MD07-2025/26 (29 August 2025) - Reprocessing of single-use medical devices
• MD08-2025/2026 (19 August 2025) - Regulatory requirements for artificial intelligence and machine learning-enabled medical devices
• MD06-2025/2026 (17 July 2025) - Medical device establishment licence renewal process
• MD01-2024/2025 (16 July 2025) - Contact details for Guideline SAHPGL-MD-03: Medical Device Vigilance: Adverse Event Reporting by Licence Holders
• MD05-2025/2026 (23 June 2025) - Regulatory requirements for veterinary medical devices, including veterinary IVDs
• MD04-2024/2025 (9 April 2025) - MPXV molecular technical review applications
• MD03-2024/2025 (9 April 2025) - Regulatory requirements for Mpox diagnostic test kits
• MD02-2024/2025 (9 April 2025) - Mpox diagnostic testing
• MD01-2023/24 (13 September 2024) - Mpox diagnostic testing
• MD01-2024/2025 (9 July 2024) - Contact details for Guideline SAHPGL-MD-03: Medical Device Vigilance: Adverse Event Reporting by Licence Holders
• Medical device registration voluntary feasibility study letter of intent (17 May 2024)

2023 and 2022 communications

• MD038 (2 October 2023) - SAHPRA position on the EU regulatory transition from MDD/AIMDD/IVDD to MDR 2017/745 and IVDR 2017/746
• MD037 (22 July 2022) - Withdrawal of Section 21 authorisation: use of unregistered, rapidly developed non-invasive ventilators
• MD036 (16 June 2022) - COVID-19 test kit lot verification
• Retention fee notice (24 June 2022)
• Conformity Assessment Body DoC template (30 March 2022)
• Conformity Assessment Body (CAB) checklist requirements for SAHPRA recognition (24 March 2022)
• MD035 (24 March 2022) - Usability study requirements for COVID-19 self-test kits
• MD034 (17 March 2022) - Conditions of use for COVID-19 antigen self-test kits
• MD033 (18 March 2022) - Specification standard for COVID-19 rapid antigen self-test kits
• MD032 (19 August 2022, version 2) - ISO 13485 conformity assessment body communication
• Communication to stakeholders on the status of medical device regulations (23 March 2022)
• Upcoming SAHPRA-industry workshop (17 March 2022)
• MD031 (22 September 2022, version 2) - Medical device establishment licence renewal process
• MD030 (2 February 2022) - Medical device establishment licence renewal: ISO 13485 certificate communication

2021 and 2020 communications

• MD029 (24 June 2021) - Renewal of Section 21 authorisation: use of unregistered, rapidly developed non-invasive ventilators
• MD028 (27 May 2021) - Retention fee communication
• MD027 (12 March 2021) - Section 21 authorisation for the importation of Research Use Only (RUO) IVDs
• MD025 (24 September 2020) - Alternative licensing and regulatory pathways for face masks
• MD025 (22 September 2020) - Licensing and regulatory requirements for the manufacture and distribution of medical masks and respirators during COVID-19
• MD024 (19 September 2020) - FAQ: performance evaluation of point-of-care COVID-19 serological antibody test kits
• MD022 (19 August 2020) - Clinical evaluation applications: medical devices and IVDs
• MD021 (13 August 2020) - Use of SARS-CoV-2 antibody tests (NDOH)
• MD020 (3 July 2020, version 2) - Certificate of Free Sale
• MD019 (16 July 2020) - Processing of licence applications
• MD018 (23 July 2020) - Specifications for molecular test kits
• MD017 (15 July 2020) - COVID-19 molecular test technical review applications
• MD016 (16 July 2020) - Conditions of use for COVID-19 serological test kits
• MD015 (17 March 2022, version 2) - Process for importing COVID-19 test kits
• MD014 (17 July 2020) - Regulatory requirements for molecular test kits
• MD013 (17 July 2020) - Process for locally manufactured COVID-19 test kits
• MD012 (31 July 2020) - Notice of contravention of Act 101 of 1965
• MD011 (15 July 2020) - Licence conditions for COVID-19 serological test kits
• MD010 (13 May 2020) - Guideline for rapidly developed ventilators
• MD009 (17 July 2020) - Alternative licensing regulatory requirements for alcohol-based sanitisers
• MD008 (16 July 2020) - ISO standards for medical devices and protective clothing
• MD007 (14 July 2020, version 2) - Specification standard for serological test kits
• MD006 (9 July 2020) - Laboratory testing and use of COVID-19 serological test kits
• MD005 (16 July 2020) - Rapid regulatory pathway for medical devices
• MD003 (9 July 2020) - COVID-19 testing
• MD002 (17 July 2020, version 2) - Regulatory requirements for serological test kits
• MD001 (16 July 2020, version 2) - Regulatory requirements for COVID-19 medical devices
• MD004 (5 March 2020) - Extension: use of a confirmation letter in place of a licence

Earlier position statements and communications

• Industry communication: licence amendments (27 November 2019)
• Industry communication: licence confirmation letter (28 November 2019)
• 9.96 - Transitional arrangements for medical devices (27 April 2017)
• 9.106 - Class A medical devices (14 September 2017)
• 9.105 - Section 21 authorisation for the sale of unregistered medical devices (16 November 2017)
• 9.103 - Tissue engineered products (16 November 2017)
• 9.79 - Medical device establishments: licence requirements (21 September 2016)
• 9.78 - Disinfectants: status of antiseptics and biocides (21 July 2016)
• 2.32 - Wound dressings (23 November 2011)

AIMEILI regulatory interpretation

The publication is a consolidated index rather than a new set of requirements, but it maps the regulatory expectations that SAHPRA applies to licence holders, importers and applicants across the product lifecycle, from pre-market authorisation to post-market vigilance.

Key signals in the most recent communications

• MD01-2026/27 (RUO and IUO devices): SAHPRA has clarified the regulatory treatment of devices supplied for research use only and investigational use only. This is directly linked to importation under Section 21 authorisation, and suppliers of RUO/IUO reagents and IVDs should review how such products are labelled, promoted and imported.
• MD03-2026/27 (electronic IFU): SAHPRA has begun to accept electronic instructions for use, subject to specific format and content requirements. Manufacturers should confirm the conditions under which e-IFU may replace paper IFU, and how the electronic format is controlled and version-managed.
• MD02-2026/27 (outsourced or contracted activities): Licensing requirements now explicitly address outsourcing and contract activities, and the licence holder remains responsible for subcontractors. Where a local representative or contract manufacturer is appointed in South Africa, that party must itself hold the appropriate licence and be able to demonstrate compliance.
• MD08-2025/2026 (AI/ML-enabled devices), MD07-2025/26 (reprocessing of single-use devices) and MD01-2025/2026 (ISO 13485 as a licence prerequisite): these confirm that SAHPRA is building out requirements for software-driven devices, reprocessing and quality system evidence, and that ISO 13485 certification is now integral to establishment licensing.
• Vigilance contact details (MD04-2026/27, MD01-2024/2025): the repeated updates to the contact details for Guideline SAHPGL-MD-03 signal that adverse event reporting by licence holders is an active supervisory focus.

How to classify this type of information

For international registration purposes, information of this kind should not be treated merely as industry news. Companies should first determine whether it constitutes regulatory policy, guidance or standards, device approval, recall or safety information, performance-related information, quality system requirements or post-market surveillance information. Each category has a different impact on the registration pathway, technical documentation, labelling and instructions for use, risk management and ongoing market maintenance.

It should also be noted that SAHPRA issues a substantial volume of its interpretations through industry communications. Although these documents are often explanatory rather than legislative, they can shape how assessors apply the regulations, and they should not be disregarded in regulatory planning.

Business impact and recommended actions

• Confirm applicability: check whether the product portfolio involves any of the subjects covered, such as e-IFU, RUO/IUO labelling, outsourced activities, AI/ML functionality, single-use device reprocessing or veterinary devices.
• Verify the evidence chain: confirm that existing technical files, risk management files, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, ISO 13485 certification and post-market surveillance records still support the current South African requirements.
• Review the local supply chain: where a local representative, importer, distributor or contract manufacturer is appointed, verify that licensing status and responsibilities are documented, and that the licence holder retains oversight of subcontracted activities.
• Assess change implications: where an e-IFU is adopted or a supplier arrangement changes, evaluate whether the registration file, establishment licence product list or licence conditions require notification or amendment.
• Maintain a tracking mechanism: record the official source link, publication date, applicable product scope and potentially affected areas in a regulatory intelligence log, and assess each new communication as it is issued.

For companies pursuing registration in multiple markets, the more important consideration is the boundary of document reuse. The same CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one jurisdiction, while another jurisdiction requires localised explanations, translated labelling, authorised representative documentation or a post-market maintenance plan. A short documentation gap review after each significant regulatory update helps avoid later deficiencies during correction, change notification or licence renewal.

Frequently asked questions

Can the 25 June 2026 SAHPRA consolidated communication list be used directly as a basis for an application?

No. The list is a reference index of SAHPRA communications and can support preliminary understanding and project scoping, but formal applications must be based on the latest requirements of the target regulatory authority, the confirmed product classification and the company's own documentation.

What should a company do first after reviewing this update?

Conduct a documentation gap assessment. Determine whether the update affects the registration pathway, technical documentation, labelling and instructions for use, the quality management system or post-market maintenance arrangements, and assign corrective actions accordingly.

Does the publication of an updated list mean existing registrations must be resubmitted?

Not automatically. Most of the listed documents are explanatory industry communications rather than new legislative requirements. However, where a communication clarifies licence conditions, renewal processes, e-IFU use or outsourced activity responsibilities, the licence holder should confirm that current arrangements remain compliant and take action through the appropriate notification or amendment procedure.

Source, review and scope of application

Source authority: South African Health Products Regulatory Authority (SAHPRA). Original publication date: 25 June 2026. Source link: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-comunication-to-industry/.

Content prepared by: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principle: priority is given to official regulatory authorities, international organisations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting reference.

Scope of application: this article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target regulatory authority, test conclusions or legal advice. Specific requirements remain subject to the latest official publications of the regulatory authority.