Medical Device Classification South Africa: Classes A-D

Medical device classification in South Africa is based on risk. Every medical device and in vitro diagnostic medical device, or IVD, must be assessed against the applicable South African classification rules to determine whether it falls into Class A, B, C or D.

The classification is more than an administrative label.

It can affect establishment licensing, product listings, technical documentation, conformity evidence and the regulatory pathway that applies to the product. As South Africa continues developing its broader medical device registration framework, correct classification will also be important in determining how different products are called up and assessed.

Under the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, Class A represents the lowest risk level, followed by Classes B and C, with Class D representing the highest risk. If classification is inconclusive and a device could fall into more than one class, the higher risk classification applies.

SAHPRA’s March 2024 classification guideline provides the detailed rules manufacturers and distributors should use when classifying both non-IVD medical devices and IVDs for the South African market.

Why medical device classification matters in South Africa

Classification determines the regulatory risk assigned to a medical device.

South Africa’s medical device regulations specify four risk classes: Class A, Class B, Class C and Class D.

Classification influences several downstream regulatory decisions, including establishment licensing, product listing, technical documentation and the future product-registration pathway.

Classification should therefore be determined before a company finalises its licensing or market-entry strategy.

Verion Medical provides dedicated medical device classification support as part of its broader medical device registration services.

The four SAHPRA medical device classes

For non-IVD medical devices, the four classes are:

Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk

For IVDs, the same letters are used, but the risk description focuses on individual and public-health risk.

Class A: No public-health risk or low personal risk
Class B: Low public-health risk or moderate personal risk
Class C: Moderate public-health risk or high personal risk
Class D: High public-health risk

The class is determined by intended purpose, design, mode of action and the risks associated with use of the device.

Who is responsible for determining classification?

The manufacturer or distributor is responsible for determining the appropriate classification using SAHPRA’s classification rules.

For non-IVD devices, relevant factors include intended use, level of risk, degree of invasiveness and duration of use or exposure.

The applicant should be able to explain why the product belongs in the selected class.

A structured classification rationale is particularly important where the product could potentially fall within more than one rule.

Why intended purpose is critical

The intended purpose is the starting point for classification.

Relevant sources include the instructions for use, label, manufacturer advertising and technical documentation.

Two devices that look almost identical can fall into different risk classes if their intended purposes differ.

This is why regulatory teams should review marketing claims before classification is finalised.

The intended purpose should remain consistent across the classification rationale, labelling, instructions for use, technical documentation and marketing material.

How non-IVD medical devices are classified

SAHPRA applies technical classification rules to non-IVD medical devices.

The rules consider whether the device is non-invasive, invasive, surgically invasive, implantable, active, intended for diagnosis or therapy, intended to administer substances, incorporates medicinal or biological material, or has other characteristics specified in the classification rules.

Duration is particularly important for invasive devices.

Transient use means continuous use for less than 60 minutes.

Short-term use means continuous use for at least 60 minutes but no more than 30 days.

Long-term use means continuous use for more than 30 days.

These distinctions can materially change classification.

Understanding Class A medical devices

Class A generally contains lower-risk devices.

Examples can include certain non-invasive devices and some reusable surgical instruments.

However, a product should never be assumed to be Class A merely because it appears simple.

A change in sterility, intended purpose, composition or clinical application can move the product to a higher class.

Our dedicated article Do Class A Medical Devices Need a SAHPRA Licence? addresses the licensing implications separately.

Understanding Class B medical devices

Class B generally represents low to moderate risk.

Many products fall into this category because their degree of invasiveness, duration of use or active function creates more risk than a basic Class A product but does not justify a higher classification.

Examples may include certain surgically invasive devices intended for transient use and some active therapeutic or diagnostic devices.

Devices arrive at Class B through different classification rules, so the full rule set must still be considered.

Understanding Class C medical devices

Class C represents moderate to high risk.

Devices may fall into Class C because of greater invasiveness, longer duration of use, higher clinical consequence if the device fails or potentially hazardous delivery of energy or substances.

Examples can include certain ventilators, infusion pumps, anaesthesia equipment, dialysis equipment and other devices where failure or incorrect operation may create substantial risk.

The correct classification should always be determined from the applicable rule rather than from examples alone.

Understanding Class D medical devices

Class D represents the highest regulatory risk category.

Certain implantable devices, devices incorporating medicinal substances and devices containing specified human, animal, microbial or recombinant material can fall into Class D.

Some long-term invasive contraceptive devices are also Class D.

A high-risk device requires particularly careful classification and supporting regulatory justification.

How IVD classification differs

IVDs use the same Class A to D structure, but the classification logic focuses strongly on the consequence of the information produced by the test.

An incorrect result can affect clinical diagnosis, treatment selection, blood or tissue safety, public-health response, pregnancy management or management of life-threatening disease.

SAHPRA therefore considers both individual risk and public-health risk when classifying IVDs.

How Class A, B, C and D apply to IVDs

Class D IVDs include certain tests associated with transmissible agents posing a high public-health risk and some tests used to establish the safety of blood, tissues or organs for transfusion or transplantation.

Class C IVDs include many tests where an incorrect result can create high personal risk or significant public-health consequences, including certain infectious-disease, genetic, cancer and self-testing applications.

Class B IVDs include other IVDs that do not fall into higher-risk or specifically lower-risk rules and non-assay-specific quality-control materials.

Class A IVDs can include specified instruments, specimen receptacles, microbiological culture media and certain reagents intended for IVD procedures.

What happens when more than one classification rule applies?

Where more than one classification rule applies, the higher classification generally takes precedence.

Manufacturers and distributors must therefore consider all potentially applicable classification rules.

This is particularly important for complex devices that incorporate medicines, biological material or other characteristics covered by additional rules.

Accessories, systems and procedure packs

Accessories should be classified separately according to their own intended purpose and characteristics.

For systems and procedure packs, the overall classification generally follows the highest classification of an individual device in the system or pack.

Manufacturers assembling kits should therefore classify the individual components before determining the overall classification.

Software and active medical devices

Software can itself qualify as a medical device.

Software meeting the medical-device definition is treated as an active medical device under SAHPRA’s classification framework.

Software intended to operate or control another medical device may generally follow the classification of the device it controls, while software functioning as an accessory may need to be classified separately.

Our dedicated guide to Software as a Medical Device in South Africa addresses this subject separately.

Sterile and measuring devices

Sterility and measuring functionality can materially affect the regulatory treatment of Class A devices.

A manufacturer, distributor or wholesaler should therefore not see the words “Class A” and automatically conclude that no establishment licence is required.

The specific characteristics of the product must be considered.

Is a Class A medical device exempt from SAHPRA licensing?

SAHPRA Position Statement 9.106 states that manufacturers, distributors and wholesalers of Class A medical devices with a measuring function or devices required to be sterile must apply for a medical device establishment licence.

Manufacturers, distributors and wholesalers dealing with other Class A medical devices were not required to apply for an establishment licence until further notice, although nothing prohibited them from applying.

This means that Class A does not automatically equal licence exemption.

The exemption concerns establishment licensing and should not be interpreted as meaning that the product falls outside the medical-device regulatory framework.

For a focused explanation, see Do Class A Medical Devices Need a SAHPRA Licence?

Foreign classifications cannot simply be copied

International manufacturers frequently arrive with an existing EU, FDA, TGA or other foreign classification.

That information is useful, but it is not automatically determinative in South Africa.

SAHPRA’s classification guidance states that a medical device or IVD may have a different classification in South Africa from the classification applied in another country.

The correct question is: Which SAHPRA classification rule applies to the device as it will be supplied in South Africa?

Classification and SAHPRA establishment licensing

Device classification feeds directly into establishment licensing.

A licence applicant must identify the products and risk classes associated with the activities it intends to perform.

Classification should therefore be confirmed before the product list is finalised.

Our SAHPRA Medical Device Establishment Licence guide explains the licensing framework, while Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence focuses on selecting the appropriate licence.

Verion Medical also provides SAHPRA establishment licensing support.

Classification and future medical device registration

Classification is also central to South Africa’s developing product-registration system.

The medical device regulations provide for risk-based classification and registration through call-up notices.

During 2024, SAHPRA launched a voluntary medical-device registration feasibility study that included classification documentation within the proposed registration framework.

Manufacturers should therefore maintain a defensible South African classification as part of registration readiness.

For more detail, see Medical Device Registration in South Africa: SAHPRA Requirements.

Common medical device classification mistakes

Common errors include copying a foreign classification, relying only on product appearance, considering only one rule, overlooking duration of use, ignoring sterility or measuring function, overlooking medicinal or biological components and failing to document the classification rationale.

Another common mistake is applying non-IVD logic to an IVD or assuming that an accessory must automatically carry the same classification as the main device.

Classification should be treated as a regulatory assessment rather than a field to be completed on a product spreadsheet.

What should a classification assessment contain?

A classification assessment should create a traceable regulatory rationale.

Relevant information should include:

product name and model or family;
original manufacturer;
medical device or IVD status;
intended purpose;
patient or user population;
duration of use;
invasiveness;
whether the device is active or implantable;
sterility;
measuring functionality;
medicinal or biological components;
potentially applicable SAHPRA rules;
the final classification rule;
Class A, B, C or D conclusion; and
the regulatory justification.

If the conclusion remains uncertain, appropriate regulatory clarification should be sought rather than forcing the product into a preferred lower class.

Key regulatory references

How Verion Medical supports medical device classification

Verion Medical supports manufacturers, importers, distributors and wholesalers with the classification of medical devices and IVDs for the South African market.

Our dedicated medical device classification service can support the review of intended purpose, device characteristics, risk factors and applicable SAHPRA rules to develop a documented classification rationale.

Where classification forms part of a wider regulatory project, Verion Medical also provides medical device registration support, technical documentation and labelling support, regulatory affairs services and SAHPRA establishment licensing support.

For international manufacturers, we can also assess whether an overseas classification remains appropriate when the South African classification rules and intended purpose are applied.

If you need to confirm whether a medical device or IVD is Class A, B, C or D before licensing or entering the South African market, contact Verion Medical for a classification assessment.