Medical Devices and IVDs in South Africa: Regulatory Guide

Published: 12 September 2023
Last updated: 30 September 2026

Medical devices and IVDs in South Africa are regulated through a combination of legislation, SAHPRA regulations, establishment licensing requirements, quality management obligations and product-specific controls. For manufacturers, importers, distributors and wholesalers, the regulatory pathway starts before a product is shipped or placed on the market.

The South African Health Products Regulatory Authority, commonly known as SAHPRA, regulates medical device establishments and the evolving registration framework for medical devices and in vitro diagnostic medical devices, or IVDs. The framework applies both to the organisation carrying out regulated activities and to the products that organisation intends to manufacture, import, distribute or wholesale.

For companies entering the South African market, it is important to separate several concepts that are sometimes treated as though they mean the same thing: device classification, establishment licensing, product listing, product registration, quality management and post-market compliance. Each serves a different regulatory purpose.

Who regulates medical devices and IVDs in South Africa?

The legal foundation for medical device regulation is the Medicines and Related Substances Act 101 of 1965, as amended, together with the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, published in Government Gazette No. 40480 on 9 December 2016.

Those regulations provide the framework for matters including the importation of medical devices and IVDs, licensing of manufacturers, distributors and wholesalers, product registration, classification, adverse-event reporting, advertising, labelling and instructions for use.

SAHPRA is the national regulatory authority responsible for administering this framework. Its Medical Devices Unit regulates the licensing of medical device establishments and the registration framework for both IVD and non-IVD medical devices.

This means that a company should not view South African compliance as a single approval exercise. The company itself may require a SAHPRA medical device establishment licence, while each device or IVD must also be appropriately classified, listed where applicable, supported by suitable technical documentation and managed under an appropriate quality system.

What qualifies as a medical device or IVD?

The definition of a medical device is intentionally broad. It can include instruments, apparatus, equipment, implants, software, materials, reagents and other articles intended for medical purposes such as diagnosis, prevention, monitoring, treatment or alleviation of disease or injury.

An IVD is a type of medical device intended for the examination of specimens derived from the human body outside the body. IVDs may be used to provide information about diagnosis, physiological or pathological conditions, compatibility, treatment monitoring or other defined medical purposes.

The intended purpose is central to determining whether a product falls within the medical-device framework. A product that appears similar to a conventional consumer product may become a medical device because of the claims made for it, the population for which it is intended, the way it is used or the information it is designed to provide.

This is particularly important for diagnostic products and software. Digital products should not be assumed to fall outside medical-device regulation simply because there is no conventional physical device. Manufacturers developing software-based technologies should assess whether the product meets the medical-device definition and, if so, how it should be classified. Our dedicated guide to Software as a Medical Device in South Africa addresses that pathway separately.

Medical device classification in South Africa

South Africa uses a risk-based classification system for medical devices and IVDs. Devices are placed into Class A, Class B, Class C or Class D, with regulatory risk generally increasing from Class A to Class D.

Classification is not based on the commercial importance or price of a product. It is driven by the device’s intended purpose and the applicable classification rules. Relevant factors can include whether the device is invasive, how long it remains in contact with the body, whether it is active, whether it is implantable, whether it has a measuring function and the potential consequences if the device fails.

IVDs also use Classes A to D, but the IVD rules focus on factors such as individual risk and public-health risk.

Correct classification matters because it influences the regulatory pathway, the information expected from the applicant and the way the product is represented on establishment licence documentation. A company should therefore establish classification before finalising licensing, technical documentation or market-entry planning.

Verion Medical provides dedicated medical device classification support, and our detailed article on medical device classification in South Africa examines Classes A, B, C and D in greater depth.

SAHPRA currently maintains a licensing exemption for manufacturers, distributors and wholesalers dealing only with non-sterile, non-measuring Class A medical devices. That exemption is narrow and should not be interpreted as a general exemption for all Class A products or all regulatory obligations.

The implications of this exemption are covered separately in Do Class A Medical Devices Need a SAHPRA Licence?

Medical device establishment licensing

SAHPRA currently recognises three principal types of medical device establishment licence: manufacturer, distributor and wholesaler.

A manufacturer’s licence covers manufacturing and can also cover import, distribution and export activities associated with the licensed establishment. Manufacturing is broader than simply fabricating a finished product. It can include design, assembly, processing, reprocessing, packaging, repackaging, labelling and refurbishment.

A distributor’s licence covers importing, exporting and distributing medical devices or IVDs.

A wholesaler’s licence has a different scope. It focuses on procuring, storing and distributing products locally. A wholesaler’s licence does not permit the holder to import or export medical devices in its own right, although a wholesaler may store or export products on behalf of an approved manufacturer or distributor.

The correct licence should therefore be selected according to the activities actually performed at the site. Choosing a licence simply because a company describes itself commercially as a distributor, supplier or agent can create regulatory scope problems later.

The 2017 establishment licensing call-up required manufacturers, distributors and wholesalers to obtain medical-device establishment licences within the prescribed implementation periods. Establishment licensing has therefore become a core element of the South African medical-device market-access pathway.

Companies planning an application can start with our SAHPRA Medical Device Establishment Licence guide and Verion Medical’s establishment licensing services.

Where there is uncertainty about the correct licence type, our guide on manufacturer, distributor and wholesaler SAHPRA licence types explains the distinctions. Dedicated articles also address the medical device manufacturer licence and medical device wholesale licence.

The SAHPRA Authorised Representative

An establishment applying for a SAHPRA medical-device licence must appoint an Authorised Representative.

Under the regulatory framework, the Authorised Representative is a natural person resident in South Africa who has the mandate to represent the relevant establishment and carries defined regulatory responsibilities.

The role should not be treated as a name placed on an application form.

The Authorised Representative should have sufficient knowledge of the company’s regulated activities and access to the information necessary to support regulatory compliance.

For international manufacturers, this makes the local operating model particularly important. Responsibilities should be clear between the foreign manufacturer, South African licence holder, Authorised Representative, logistics providers and any other contracted parties.

Product documentation, complaints, vigilance, regulatory correspondence, product-list changes and quality records should be allocated deliberately rather than left to informal commercial arrangements.

Our article on SAHPRA Authorised Representative requirements and responsibilities provides a more detailed explanation of the role.

Product listing and medical device registration are not the same thing

A common source of confusion is the assumption that a product appearing on a SAHPRA establishment licence product list has been fully registered by SAHPRA.

These are different regulatory concepts.

As part of establishment licensing, a company must list the medical devices and IVDs it manufactures, distributes or wholesales. Product-list information supports the scope of the establishment licence and the activities authorised under that licence.

Full product registration is a separate process.

As at this article’s 30 September 2026 update, SAHPRA states that the broader medical-device registration process is still in development. A Registration Call-Up Plan is intended to identify the device types and risk classes that will progressively be called up for registration.

In March 2026, SAHPRA published the Medical Devices Registration Feasibility Study report to support the implementation of a comprehensive, risk-based registration framework for medical devices and IVDs.

SAHPRA also published a dedicated Medical Devices Reliance Guideline in February 2026. The guideline establishes principles for using regulatory reliance across premarketing and post-marketing activities, including establishment licensing, product registration, clinical investigations, ISO 13485-related activities and post-market regulatory functions.

For manufacturers, this means South African market entry should be planned around the regulatory system actually in force while maintaining readiness for a progressively expanded registration framework.

Our dedicated guide to medical device registration in South Africa examines the difference between current requirements and the developing registration system.

ISO 13485 and quality management system requirements

A documented quality management system is central to medical-device establishment compliance.

SAHPRA’s Quality Manual guideline requires a documented QMS relevant to the lifecycle activities performed by the establishment. The Quality Manual should describe the organisation, facilities, key personnel, policies, procedures, work instructions, controls and activities used to demonstrate consistent compliance.

Wholesalers are treated differently in the establishment application process. Manufacturers and distributors submit a Quality Manual, while wholesalers submit a Site Master File.

ISO 13485 certification is being implemented through a phased SAHPRA programme.

From 1 June 2025, manufacturers and distributors applying to renew a medical-device establishment licence are required to provide a valid ISO 13485:2016 certificate issued by a conformity assessment body recognised by SAHPRA, or documentary evidence of the certification process where applicable.

Phase 3 took effect on 1 April 2026. Under this phase, manufacturers and distributors that already hold a valid ISO 13485 certificate, but are not applying for a new licence, renewal or amendment, are requested to submit that certificate to SAHPRA for verification.

The practical implication is that ISO 13485 should be built into the operating model rather than treated as a document required only when a licence application becomes due.

A functioning QMS should cover areas such as supplier control, training, document control, complaints, corrective and preventive action, internal audits, management review, storage and distribution.

Our ISO 13485 and Quality Management Systems services support companies establishing and strengthening these systems, while ISO 13485 in South Africa examines SAHPRA’s requirements in detail.

Technical documentation and labelling

Technical documentation remains important even where a particular medical device has not yet been called up for full registration.

The manufacturer should be able to support the safety, quality and performance of the device with appropriate records. Depending on the product, this may include the intended purpose, device description, design and manufacturing information, risk-management documentation, verification and validation evidence, clinical or performance evidence, stability information, labelling and instructions for use.

The strength of the technical file should reflect the device’s risk and intended use. A foreign approval, CE marking or registration in another recognised jurisdiction may be relevant, but it does not remove the need to understand the South African regulatory pathway.

Verion Medical provides technical documentation and labelling support as part of its medical-device regulatory services.

Labelling and instructions for use are themselves regulated under the 2016 Medical Device and IVD Regulations.

In May 2026, SAHPRA issued specific regulatory requirements for electronic instructions for use, or e-IFU, for medical devices. Manufacturers supplying information electronically should therefore assess whether their approach complies with the South African requirements.

Importing and distributing medical devices

Importation should be considered as part of regulatory planning, not as a separate logistics activity that starts after regulatory work has been completed.

A company importing medical devices into South Africa should confirm that the relevant establishment holds the correct licence type and that the products fall within the authorised scope. The responsibilities of the manufacturer, importer, storage provider and distributor should also be documented and understood.

Verion Medical’s medical device import and export services support companies in aligning import arrangements with the applicable regulatory requirements.

SAHPRA has continued to clarify the licensing implications of outsourced activities. In April 2026, the Authority issued a communication specifically addressing licensing requirements for outsourced or contracted activities performed for medical-device establishments.

This matters where a licence holder relies on third parties for storage, distribution, manufacturing or other regulated activities. Licence holders using third parties for regulated activities should ensure that those service providers hold the appropriate medical-device establishment licence where required.

In September 2026, SAHPRA also issued specific requirements for the importation of unregistered or listed medical devices intended for exhibition, appraisal, demonstration or training. These situations should not be treated as equivalent to ordinary commercial importation.

Post-market vigilance and ongoing compliance

Regulatory responsibility continues after a device has entered the market.

Licence holders and manufacturers must be able to receive, investigate and act on information relating to product quality, performance and safety. This includes complaint handling, adverse-event assessment, corrective action, traceability and recall readiness.

SAHPRA’s medical-device adverse-event reporting framework provides requirements for assessing and reporting relevant events to the Authority.

In September 2025, SAHPRA published a dedicated guideline on Post-Market Surveillance and Post-Market Clinical Follow-up. The guideline reinforces the expectation that post-market surveillance forms part of the manufacturer’s quality system and supports the identification and investigation of residual risks arising during wider use of the device.

The regulatory lifecycle therefore does not end when an establishment licence is issued or when the first shipment arrives. Ongoing compliance requires a functioning system capable of identifying issues, assessing their significance and responding appropriately.

What foreign manufacturers should address before entering South Africa

Foreign manufacturers should map the South African regulatory pathway before committing to a launch date or appointing a local commercial partner.

At a minimum, the manufacturer should establish:

whether the product meets the South African definition of a medical device or IVD;
the correct risk classification;
whether the Class A licensing exemption is relevant;
which South African entity will hold the applicable establishment licence;
whether the proposed activities require a manufacturer, distributor or wholesaler licence;
who will serve as the Authorised Representative;
whether the QMS and ISO 13485 position is suitable;
whether product documentation and labelling are ready for the South African market;
how importation, storage and distribution will be controlled; and
how complaints, vigilance and regulatory changes will be managed after launch.

This assessment is particularly important where a manufacturer is appointing a distributor for the first time. Commercial reach is important, but the regulatory and quality capabilities of the local operating model can directly affect market continuity.

The most efficient approach is to treat regulatory affairs, quality, importation and commercial market entry as connected workstreams rather than sequential tasks handled by unrelated teams.

Our guide to medical device market entry in South Africa explains the pathway specifically for international manufacturers, while Verion Medical’s market development services support the commercial side of market entry.

How the South African regulatory framework is developing

The core legal framework remains the Medicines and Related Substances Act and the 2016 Medical Device and IVD Regulations, but regulatory implementation continues to evolve.

Recent developments include updated classification guidance, the phased ISO 13485 certification programme, the 2025 post-market surveillance and clinical follow-up guideline, the 2026 Medical Devices Reliance Guideline, the Medical Devices Registration Feasibility Study, electronic instructions for use requirements, guidance on outsourced activities and more detailed requirements for specific import scenarios.

For companies already operating in South Africa, this means compliance should not be based solely on what was required when the original establishment licence was issued.

For new market entrants, regulatory intelligence should be built into the market-entry strategy from the beginning.

Key regulatory references

Medicines and Related Substances Act 101 of 1965, as amended
Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, Government Notice 1515, Government Gazette No. 40480
SAHPGL-MD-04, Guideline for Classification of Medical Devices and IVDs
SAHPGL-MD-05, Guideline on Medical Device Quality Manual
MD01-2025/2026, ISO 13485 Certificate as a Prerequisite for the Approval of a Medical Device Establishment Licence
SAHPGL-MD-18, Post-Market Surveillance and Post-Market Clinical Follow-up Studies
SAHPGL-MD-22, Medical Devices Reliance Guideline
Medical Devices Registration Feasibility Study report
MD03-2026/27, Regulatory Requirements for Medical Devices Electronic Instructions for Use
MD02-2026/27, Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments

How Verion Medical supports medical device and IVD companies

Verion Medical supports medical device and IVD manufacturers, importers, distributors and wholesalers with regulatory and operational requirements for the South African market.

Our support includes medical device regulatory affairs, medical device registration support, device classification, SAHPRA establishment licensing, technical documentation and labelling, ISO 13485 and Quality Management Systems, import and export support and market development.

For international manufacturers, Verion Medical can connect these requirements into one practical pathway, from assessing product classification and determining the appropriate local licensing model through to regulatory documentation, QMS readiness, importation and compliant market entry.

If your organisation is preparing to manufacture, import, distribute or wholesale medical devices or IVDs in South Africa, contact Verion Medical to discuss the regulatory pathway that applies to your products and operating model.