Medical Device Registration in South Africa

Medical device registration in South Africa is often misunderstood because the country’s regulatory framework combines establishment licensing, product listing, classification and a developing product-registration system.

Manufacturers entering South Africa sometimes assume that every medical device must first receive an individual SAHPRA registration certificate before it can be supplied. Others make the opposite assumption and treat establishment licensing as though it replaces all product-level regulatory obligations.

Neither approach accurately reflects the regulatory position.

As of 26 February 2026, the South African Health Products Regulatory Authority, or SAHPRA, states that the broader registration process for medical devices is still in development. SAHPRA intends to implement registration progressively through a Registration Call-Up Plan that will identify the device types and classes to be prioritised.

At the same time, substantial requirements already apply to companies manufacturing, importing, distributing and wholesaling medical devices and in vitro diagnostic medical devices, or IVDs.

Understanding the difference between what is required now and what forms part of the developing registration framework is therefore essential for regulatory planning.

What does medical device registration mean in South Africa?

The legal basis for medical device registration already exists.

The Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, published under Government Notice 1515 in December 2016, specifically provide for applications for registration, the medical-device register, amendments to registered information, device classification and registration certificates.

This means product registration is not a new concept being created from scratch. The legislation established the regulatory mechanism years ago.

What has been developing is the operational implementation of broad product registration across the South African medical-device market.

SAHPRA’s public guidance states that the medical-device registration process remains under development and that a Registration Call-Up Plan will identify the medical-device types and risk classes to be called up sequentially.

This distinction matters.

The legislation enables product registration, but manufacturers should not assume that every medical device currently on the South African market has undergone the same type of individual pre-market registration used in some other jurisdictions.

For a wider overview of the system, see our guide to medical devices and IVDs in South Africa.

Is every medical device currently required to be registered?

No. As at the publication of this article, SAHPRA has not implemented broad compulsory individual registration across every category of medical device and IVD.

SAHPRA states that the registration process remains under development and that future implementation will occur through a phased call-up approach.

This does not mean medical devices are unregulated.

Companies may still have significant regulatory obligations before manufacturing, importing or distributing products in South Africa.

These can include:

determining whether the product meets the definition of a medical device or IVD;
assigning the correct South African risk classification;
obtaining the appropriate medical-device establishment licence;
appointing an Authorised Representative;
maintaining an appropriate quality management system;
complying with ISO 13485 requirements where applicable;
including devices on the establishment’s approved product listing;
maintaining suitable technical documentation;
meeting labelling and instructions-for-use requirements;
complying with additional controls applicable to particular products; and
meeting post-market vigilance obligations.

So the correct question is usually not simply, “Does my device need registration?”

The better question is: What regulatory pathway applies to this device and to the South African company that will manufacture, import, distribute or wholesale it?

Verion Medical’s medical device registration services are structured around answering that broader regulatory question.

Establishment licensing and product registration are different

One of the most important points for manufacturers to understand is that a SAHPRA medical-device establishment licence is not the same as a product registration certificate.

Establishment licensing regulates the organisation conducting specified activities.

South Africa currently recognises manufacturer, distributor and wholesaler establishment licences. Manufacturers may conduct manufacturing and associated activities within their approved scope, distributors can undertake import, export and distribution activities, while wholesalers focus on local procurement, storage and distribution.

Product registration, by contrast, concerns the regulatory authorisation of an individual device or defined device grouping under the registration framework.

A company can therefore hold a valid establishment licence without that fact alone meaning every product appearing on its licence has undergone full SAHPRA product registration.

This is why terminology matters.

A product being listed on an establishment licence should not automatically be described as a SAHPRA-registered medical device.

Companies that need to determine which establishment licence applies to their operation should review our SAHPRA medical device establishment licence guide and establishment licensing services.

Where the distinction between manufacturer, distributor and wholesaler activities is unclear, see Choosing the Right SAHPRA Medical Device Licence.

Classification comes before registration

Correct classification is one of the first product-level regulatory decisions.

South Africa classifies medical devices and IVDs into Classes A, B, C and D according to risk.

The applicable classification depends on factors such as the intended purpose, duration of use, invasiveness, whether a device is active or implantable, anatomical location, measuring function and other characteristics defined by the classification rules.

SAHPRA’s classification guidance also makes an important point for international manufacturers: a device’s classification in South Africa may differ from its classification in another country. The applicant therefore needs to apply the South African rules rather than simply transferring a foreign classification.

Classification will become particularly important as the registration framework develops because SAHPRA has indicated that device types and classes will be called up progressively.

A manufacturer that has not established its South African classification may therefore struggle to assess when a future registration call-up applies.

For a detailed explanation, see Medical Device Classification in South Africa: Classes A, B, C and D or Verion Medical’s device classification service.

Product listing remains an important current requirement

Even though broad product registration is still being developed, product information already forms part of establishment licensing.

SAHPRA requires an applicant for a medical-device establishment licence to list the medical devices that it manufactures, distributes or wholesales.

Product listing allows SAHPRA to identify the scope of products associated with the licensed establishment.

The distinction between listing and registration becomes particularly important when companies discuss their regulatory status with international manufacturers, healthcare customers or commercial partners.

A listed device has been included within the establishment licensing framework.

A registered device would have gone through the applicable product-registration pathway and, where approved, be associated with a registration certificate or registration record.

SAHPRA also issued a communication on 27 January 2026 establishing a process for notifications involving updates to product lists attached to medical-device establishment licences.

Product-list management should therefore be treated as an ongoing regulatory responsibility rather than a once-off administrative exercise.

Quality management and ISO 13485 requirements

Product registration should not be planned separately from the manufacturer’s or local establishment’s quality system.

SAHPRA expects manufacturers and distributors to maintain an appropriate Quality Management System, while the establishment licensing framework requires supporting quality documentation.

ISO 13485:2016 has also become increasingly important in South Africa.

SAHPRA’s 2025 communication established phased implementation of ISO 13485 certification as a prerequisite associated with medical-device establishment licensing. The requirement applies particularly to manufacturers and distributors and connects regulatory licensing with demonstrable quality-system maturity.

For a manufacturer preparing products for eventual registration, an effective QMS also supports the underlying technical evidence.

Design controls, risk management, supplier controls, complaint handling, verification, validation, change control and post-market information can all feed into the documentation required to demonstrate safety, quality and performance.

This is why companies should not wait for a product-registration call-up before addressing quality-system gaps.

Our article on ISO 13485 in South Africa explains the regulatory expectations in more detail, while Verion Medical provides ISO 13485 and Quality Management Systems support.

Technical documentation manufacturers should prepare

The fact that broad compulsory product registration has not yet been fully implemented should not be interpreted as permission to postpone technical-documentation readiness.

Registration of a medical device ultimately depends on the manufacturer being able to demonstrate that the device is safe, performs as intended and meets applicable regulatory requirements.

Technical documentation may include:

device description and intended purpose;
product specifications;
design and manufacturing information;
classification rationale;
risk-management documentation;
verification and validation evidence;
electrical, mechanical or biological safety evidence where relevant;
software information where applicable;
clinical or performance evidence;
shelf-life or stability information;
sterilisation evidence where applicable;
labels and packaging;
instructions for use;
quality-system evidence;
post-market information; and
evidence of regulatory approval in other jurisdictions.

SAHPRA published draft technical-dossier guidance for both non-IVD devices and IVDs in 2023. Those documents describe detailed dossier structures and were subsequently referenced as part of the 2024 voluntary registration feasibility study.

Manufacturers should therefore organise their evidence before registration becomes a commercial deadline.

Verion Medical’s technical documentation and labelling service supports manufacturers in reviewing and structuring documentation for the South African regulatory pathway.

What the voluntary registration feasibility study tells industry

In 2024, SAHPRA launched a Medical Device Registration Voluntary Feasibility Study to test and refine the proposed product-registration process.

The study focused on devices intended for human use that were already legally imported into South Africa or manufactured locally. Participation was limited to eligible holders of medical-device establishment licences, and SAHPRA aimed to include a range of IVD and non-IVD products, particularly higher-risk Class C and D devices associated with HIV and tuberculosis diagnosis and monitoring.

The study required selected participants to prepare registration submissions supported by technical dossiers and evidence addressing the Essential Principles of Safety and Performance.

For industry, the significance of the study goes beyond the individual products involved.

It shows that SAHPRA is testing a regulatory model that draws together risk classification, establishment licensing, technical dossiers, evidence of safety and performance, conformity assessment, international regulatory history and regulatory reliance.

However, the feasibility study should not be confused with a general call-up requiring every medical device in South Africa to submit immediately for registration.

As of 26 February 2026, SAHPRA continued to state that the broader registration process remained under development.

SAHPRA’s new regulatory reliance pathway

A particularly important development occurred on 25 February 2026, one day before the publication date of this article.

SAHPRA published Version 1 of its Medical Devices Reliance Guideline, SAHPGL-MD-22.

The guideline establishes principles and procedures for reliance-based regulatory review covering both pre-market and post-market functions. SAHPRA specifically identifies product registration, establishment licensing, clinical investigations, ISO 13485-related activities and post-market surveillance among the areas in which reliance may be used.

Reliance means that SAHPRA can use regulatory work already performed by another recognised regulatory authority or trusted institution as part of its own decision-making.

It does not mean SAHPRA gives up regulatory responsibility.

SAHPRA remains responsible for the final South African regulatory decision and may request additional evidence where necessary.

This development is important because it provides a clearer indication of how future medical device registration may operate in practice.

What reliance means for international manufacturers

For international manufacturers, reliance has the potential to reduce unnecessary duplication where a device has already undergone robust regulatory assessment elsewhere.

SAHPRA’s medical-device information states that future registration will use verification of registrations in recognised jurisdictions, including Australia, the United States, the European Union, Brazil, Canada and Japan. WHO prequalification may also be relevant for IVDs.

That does not mean a foreign approval automatically becomes a South African registration.

Manufacturers still need to establish the South African regulatory pathway, classification and local licensing model.

They should also be ready to provide evidence showing:

the identity of the device approved abroad;
the applicable foreign approval or registration;
the manufacturer named on that approval;
whether the South African device is materially the same product;
applicable labels and instructions for use;
technical documentation;
quality-system certification; and
relevant post-market or safety information.

A manufacturer should therefore view international approvals as regulatory assets that may support the South African pathway, rather than as substitutes for South African compliance.

Foreign manufacturers planning local entry can also review our guide on medical device market entry in South Africa and Verion Medical’s regulatory affairs services.

Additional requirements for certain IVDs

Companies should also be careful about making blanket statements that medical devices do not require registration yet.

Certain products already attract additional product-level evidence requirements within the current regulatory system.

For example, SAHPRA’s establishment licensing guidance requires additional supporting documentation where product listings include certain diagnostic kits such as COVID-19, HIV or Mpox IVDs.

Depending on the product, the required evidence can include ISO 13485 certification for the original manufacturer, evidence of pre-market approval from a recognised jurisdiction, packaging and labelling information, instructions for use, technical dossiers containing clinical, validation and stability information, and WHO prequalification evidence where applicable.

The broader registration framework may still be developing, but manufacturers must still check whether a product is subject to specific requirements today.

What companies should do before the registration call-up

Manufacturers should use the current period to become registration-ready rather than waiting for SAHPRA to call up their device category.

First, confirm the device’s intended purpose and South African classification.

Second, ensure that the organisation responsible for manufacture, importation, distribution or wholesaling holds the correct establishment licence.

Third, confirm that each device is appropriately reflected on the establishment’s product listing.

Fourth, ensure that the Authorised Representative and local regulatory responsibilities are clearly assigned.

Fifth, review the organisation’s QMS and ISO 13485 position.

Sixth, organise the technical documentation so that the evidence needed to support safety, quality and performance can be located efficiently.

Seventh, review overseas market authorisations and determine which approvals may be relevant under SAHPRA’s reliance model.

Eighth, establish a regulatory intelligence process so that future registration call-ups can be identified quickly.

The companies that prepare these elements now should be better positioned to respond when their device category becomes subject to formal registration.

Common mistakes when planning South African registration

Several mistakes repeatedly create unnecessary regulatory risk.

The first is confusing establishment licensing with product registration.

The second is assuming that because full product registration is still being phased in, product-level documentation is unnecessary.

The third is using a foreign device classification without checking the South African classification rules.

The fourth is appointing a local commercial partner without confirming whether that partner’s licence scope and quality system support the intended activities.

The fifth is treating the product list attached to an establishment licence as equivalent to a registration certificate.

The sixth is assuming CE marking, FDA clearance or another foreign approval automatically authorises the product in South Africa.

The seventh is waiting for a registration call-up before organising the technical dossier.

The eighth is failing to monitor changes in the SAHPRA framework.

Medical device registration in South Africa is developing, but regulatory readiness is already a current business requirement.

Key SAHPRA references

Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, Government Notice 1515 of 2016
SAHPRA Medical Devices information and administration requirements
Guideline for Classification of Medical Devices and IVDs, SAHPGL-MD-04
Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs, SAHPGL-MD-06
SAHPRA Medical Device Registration Voluntary Feasibility Study documentation
Draft Registration of a Non-IVD Medical Device Technical Dossier, SAHPGL-MD-10
Draft Registration of an IVD Medical Device Technical Dossier, SAHPGL-MD-09
Medical Devices Reliance Guideline, SAHPGL-MD-22, published 25 February 2026

How Verion Medical supports medical device registration in South Africa

Verion Medical supports manufacturers, importers, distributors and wholesalers in determining and implementing the regulatory pathway for medical devices and IVDs entering the South African market.

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

For international manufacturers, Verion Medical can assess the current South African requirements, establish the appropriate local licensing structure, review classification and product-listing requirements, evaluate technical-documentation readiness and prepare the organisation for the developing SAHPRA product-registration framework.

If your company is preparing to place a medical device or IVD on the South African market, contact Verion Medical to discuss the applicable regulatory pathway.