Medicine vs Medical Device - Key Regulatory Differences in South Africa
- Damian Coetzee
- Sep 2, 2025
- 13 min read
Updated: Sep 5, 2025
Table of Contents
Introduction
The purpose of this communication is to help you differentiate important aspects that define what is a registered medicine and what is a combination medical device. Medical Device regulation and registration in South Africa and in fact Southern Africa is in its infancy and product registration policies are still being developed by the Regulators in these regions.
This summary of regulatory requirements and conditions is a motivation in support of registered medicines and prepared in defense of routine therapeutic substitution of a combination medical device for a registered medicine. We argue that a registered medicine, with reference to its therapeutic indication, cannot be routinely substituted with a combination medical device.
Registered Medicine vs Medical Device
Let's Start With Definitions – Refer Act 101/1965:
Definition of A Medicine
(a) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in—
(i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or
(ii) restoring, correcting or modifying any somatic or psychic or organic function in humans.
Definition of A Medical Device
Means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, ..[…]
(b) which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means;
The intention of medical devices are for one or more of the following:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
investigation, replacement, modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
control of conception;
disinfection of medical devices; or
providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.
The Acid Test of Whether A Product Is A Medicine or Medical Device
The acid test of whether something is or is not a medical device or an IVD is: what is it used for and how does it work?
The "how" is important because for something to be a medical device, it cannot achieve its primary intended action by pharmacological, immunological or metabolic means (so a medical device is not a drug or vaccine, for instance). These processes could support the intended functioning of a medical device but would not be the main activity.
This narrows down the possibilities somewhat, but the potential range is still extremely wide.
If the function of an instrument, apparatus, implement, machine, implant, software and the like is intended by the manufacturer to diagnose, prevent, monitor, treat or alleviate disease, then it is a medical device.
If it is intended to diagnose, monitor, treat, alleviate or compensate for an injury, it is a medical device.
The same applies if it is intended to control conception, disinfect medical devices, or support or sustain life.
It is also a medical device if it is meant to investigate, replace, modify or support the anatomy or a physiological process.
All in all, the definition of a medical device is so wide that it has some industry watchers wondering whether it includes devices such as fitness trackers, which measure the wearer's personal fitness by monitoring various factors such as heart rate, steps walked, and calories consumed.
Chances are that such items are not medical devices as long as they only provide data for the edification of the wearer.
If used for any form of diagnostics or treatment, however, then it arguably crosses the line into medical device or IVD territory. An item that almost certainly is a medical device is a blood-glucose monitor that people with diabetes might use to inform them when to take their medication. Another example is an app that sends an emergency signal in the event of a stroke, heart attack or other health crisis.
Registration as A Medicine | Classification of A Device
Medicines in South Africa are subject to a system of scheduling on the basis of the active pharmaceutical ingredients that they contain. The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use.
Devices are a self-assessment by the licensed Applicant based upon a set of classification rules supplied by the Regulatory Authority, based on:
the manufacturers or distributor’s intended use of the device or IVD;
level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm);
degree of invasiveness in the human body; and
duration of use and exposure.
The Regulatory Authority has the responsibility and authority to determine the final classification.
According to SAHPRA Guidelines medical devices are classified into the following four risk classes, determined according to published classification rules:
Class A – Low Risk
Class B – Low-Moderate Risk
Class C – Moderate-high Risk
Class D – High Risk
Where risk relates to the patient, user or to public health. The highest risk devices are those that are implantable or invasive and are used in the long term.
Current Registration Requirements For The Product
Registered Medicine
Medicines are required to be fully registered with SAHPRA (South African Health Products Authority) before they are authorized for sale in South Africa.
The SAHPRA registration process includes a scientific review of all aspects of quality, safety and efficacy for the product and marketing authorization is conditional on the Applicant meeting the strict SAHPRA Licensing standards for all partners in the supply chain, including Licensed Distributors/Wholesalers.
The conditions of registration also include stringent product quality management control, such as pharmacovigilance, post-importation quality analysis, validation of transportation, on-going stability testing, the provision of product quality review reports etc.
Medical Device
At this moment, there is no registration procedure for medical devices – this is still in development with a call-up program imminent, based upon a risk assessment – which means that Class D medical Devices will be called up first.
Registration Call-Up Plan For Medical Devices
Although, the Medicines Act and General Regulations provides for the above, SAHPRA’s registration process is currently in development. To ensure its mandate that medical devices are safe, effective and of good quality, when SAHPRA registers medical devices, it must "call-up" specific products or product classes for registration by publishing a call-up notice in the Government Gazette.
A draft call-up plan outlines the steps involved in this process. It explains that SAHPRA will use a risk-based approach in calling up medical devices for registration, prioritising the registration of more risky products and products of public health importance. Product call-ups will cover medical devices that are already on the market in South Africa as well as new medical devices that are being introduced. In the absence of medical device registration, SAHPRA has established several "quasi-registration" requirements as part of its medical device establishment licensing processes to enable oversight and control of medical devices used in South Africa.
In March 2024, SAHPRA invited the industry to submit an Expression of Interest (EOI) to take part in a Feasibility Study (NOT PILOT STUDY) for the registration of medical devices.
Borderline Products (Ref SAHPRA Guideline 2.45)
“Health products which cannot be classified as either a pharmaceutical, medical device, cosmetic, food supplement, or biocidal product because they are indistinguishable from one another are referred to as "borderline" products until SAHPRA determines their categorisation status and assigns them to a specific regulatory pathway.
SAHPRA issued a [Borderline] guideline in 2017 to provide applicants with recommendations regarding the registration of borderline and combination products. However, the guideline, which proposes the framework discussed below, has not yet been finalised.”
Determination of whether a product is a Medicine or Medical Device will consider the following:
The primary mode of action (PMOA) means “the single mode of action of a borderline product that provides the most important therapeutic action of the borderline product.”
The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effect(s) of the borderline product.
The claimed effect or purpose must be achieved by the most important therapeutic action.
Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, in or on the human or animal body, the borderline product is designated to be a medicine:
Immunological – understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction.
Metabolic – understood as an action which involves an alteration of the normal chemical processes participating in, and available for, normal body function. The fact that a product is itself metabolized does not imply that it achieves its principal intended action by metabolic means.
Pharmacological – understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent and, for the purposes of this policy, includes anti-infective activity.
Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, and the action occurs in vitro, without reintroducing a modified cellular substance to the patient, the product will be designated to be a medical device.
Where the primary intended mode of action by which the claimed effect or purpose is not achieved by pharmacological, immunological, or metabolic means, but may be assisted in that effect or purpose by pharmacological, immunological, or metabolic means, the borderline product (including a combination product) will be designated to be a medical device.
A borderline product may be classified as a medicine or a medical device, even when no explicit therapeutic claim is made. A therapeutic claim may also be implicit. Both types of claims are considered when a product is classified. Explicit claims are stated with no ambiguity with regard to their meaning or intent. In contrast, implicit claims made in the representation of a product indirectly suggest a therapeutic benefit. Product representation includes the appearance, labelling, and advertising of a product.
In the absence of either an explicit or implicit claim, a product may be classified (e.g., as a medicine or a medical device) if the intrinsic properties of the product are such that there is no other possible use. For example, acetaminophen (paracetamol) has no other use but as a medicine, so the absence of a claim will not change its classification as a medicine.
In addition to the primary mode of action – the composition and form of the product and the therapeutic effect of the product may be considered to assist in the designation of the product.
The composition and form of a product may help to distinguish a medicine from a medical device. A medical device exhibits structure in its final therapeutic form, that is, the structure of the product when it is achieving its effect.
With a medical device, its structure contributes directly to its effect. In contrast, the physical structure of a medicine (that is, in its dosage form, such as a tablet or an ointment, not its chemical structure) does not usually contribute directly to its therapeutic effect.
Consideration is also given to the therapeutic effect of a product and how this effect is achieved. In Act 101, as amended, the definition of a medicine and medical device differ respectively in whether a product is used to restore, correct or modify any somatic or psychic or organic function (as with a medicine) OR treat or alleviate a disease; treat, alleviate or compensate for an injury, or modify or support of the anatomy or of a physiological process (as with a medical device).
Bonusing and Sampling – Sections 18A and 18B of Act 101/1965
Registered Medicine
18A. Bonusing: Prohibits the supply of any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.
18B. Sampling: Prohibits sampling of any medicine, medical devices or IVD.
“For the purposes of this section ‘sample’ means the free supply of products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974.”
This includes consignment stock.
Medical Device
Although Medical Devices are referred to in Sections 18A and 18B of Act 101/1965, Medical Devices currently have a temporary exemption from these sections in the Act, by means of a three-year Section 36 exemption notice.
SEP (Single Exit Pricing)
The Medicines Act provides for a transparent pricing system which incorporates a single exit price (SEP) for medicines and scheduled substances.
The SEP is the price at which manufacturers (including importers) are required to sell medicines and scheduled substances to anyone other than the government. A pharmacy, wholesaler, distributor, or any person licensed under the Medicines Act is prohibited from selling a drug for more than the prescribed SEP.
However, pharmacists may charge an appropriate dispensing fee based on the recommendations of the Pricing Committee. This is, however, regulated by Section 22C of the Medicines Act.
Registered Medicine
Applicable to Medicines - The pricing breakdown of medicines is transparent and is regulated. These prices are published on the Department of Health website.
Annual increases are pre-set and pre-determined and published annually in the Government Gazette. Only one SEP increase is permitted annually.
Medical Device
Currently and temporarily not applicable to Medical Devices – temporary exemption granted.
Medical Device prices may be fluctuated and changed according to market needs. There are no regulatory restrictions on the pricing of Medical Devices.
Advertising Restrictions
Registered Medicine
S2 to S4 may only be advertised to the healthcare professions.
Medical Device
Class D may only be advertised to the Profession.
Medical devices are not permitted to market in South Africa unless they are listed in the South African Medical Device Register.
The CPA predominantly sets out the requirements for advertising and marketing of products and services (general, medical or otherwise). The CPA requires that the advertising and marketing of goods is to be done in a manner that is not reasonably likely to imply a false or misleading representation concerning those goods and is not misleading, fraudulent or deceptive in any way.
With respect to claims, suppliers are warned in the CPA that strict liability will be imputed onto producers, importers, distributors or retailers of any goods on which inadequate instructions or warnings are provided to the consumer relating to any hazard arising from or associated with the use of the goods.
General Legislation of Application: Consumer Protection Act (No 68 of 2008): A Measure of Risk
In South Africa, product safety in general is governed by the Consumer Protection Act (No 68 of 2008) (the CPA).
The CPA provides for the promotion of a fair, accessible and sustainable marketplace for consumer products and services and for that purpose, establishes national norms and standards relating to consumer protection, provides for improved standards of consumer information, prohibits certain unfair marketing and business practices, promotes responsible consumer behaviour, and promotes a consistent legislative and enforcement framework relating to consumer transactions and agreements.
This consequently creates an obligation on suppliers of products (from the beginning to the end of a supply chain) to provide healthcare products and medical devices free of defects.
The CPA imposes strict liability on producers or importers, distributors or retailers for any harm caused by a product (which would include medical devices) caused wholly or partly as a consequence of:
supplying unsafe goods;
a product failure, defect or hazard in any goods; or
inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods, irrespective of whether the harm resulted from any negligence on the part of the producer, importer, distributor or retailer, as the case may be.
Summary - In Terms of Current Regulations:
Medical Device establishments are required to be SAHPRA Licensed.
There is no formal SAHPRA registration procedure for medical devices as yet.
A Borderline Medical Device containing active chemical substances:
does not achieve its primary intended action by pharmacological means/action.
The pharmacological action of active ingredients in borderline medical devices is secondary and auxiliary to the primary indication of hemostasis.
Medicine is supported by vast clinical studies, experience and knowledge that backs the brand as well as the medicinal registration status.
Quality and Efficacy of Medicines throughout the distribution chain is assured by means of comprehensive Quality Management systems that are SAHPRA audited. These systems require validation throughout manufacturing, stability, transportation, post-importation quality analysis, Release procedures, distribution, marketing/sales and pharmacovigilance.
Frequently Asked Questions (FAQ)
What is the primary difference between a medicine and a medical device?
A medicine achieves its primary intended action through pharmacological, immunological, or metabolic means, while a medical device achieves its main effect through physical or mechanical means, potentially supported by pharmacological action.
How are medicines regulated in South Africa?
Medicines must be fully registered with SAHPRA, undergo scientific review for quality, safety, and efficacy, and comply with strict licensing, pharmacovigilance, and supply chain quality standards.
How does SAHPRA classify medical devices?
Medical devices are classified into four risk-based categories — Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) — based on intended use, invasiveness, duration of use, and potential risk to the patient.
Is pricing regulated for medical devices in South Africa?
No. Medical devices are exempt from single exit price (SEP) regulations, meaning their prices can vary based on market factors without regulatory restrictions.
What is a borderline product?
A borderline product is one that cannot easily be classified as a medicine, medical device, cosmetic, food supplement, or biocidal product. SAHPRA determines its classification based on its primary mode of action and intended purpose.
References
Bowmans. South Africa: Regulation of Medical Devices is Set to Become a Reality in SA, Julie Oppenheim, 30 September 2020. - https://bowmanslaw.com/insights/regulation-of-medical-devices-is-set-to-become-a-reality-in-sa/
MCC (SAHPRA) Guideline 2.45 on Borderline Products, March 2017. - https://www.mbac.co.za/wp-content/uploads/2019/10/2.45-Borderline_Products_Feb17_v1_for_comment.pdf (mbac.co.za)
Regulations Relating to Medical Devices and In-vitro Diagnostic Medical Devices (IVDs), Government Gazette No 40480, 9 December 2016 (Regulation 11(1)).URL (Gazette reference provided via SAHPRA site): https://www.sahpra.org.za/medical-devices/ (SAHPRA)
Medical Devices and Consumer Health Products 2021; Fasken Law Practice, 31 August 2021.(No current URL found—this appears to be a law firm publication not indexed publicly.)
SAHPRA publication; ITG Meeting update, November 2021. Status of Guideline 2.45 (Borderline Products) – Comments under review.(No direct URL located; likely internal or unpublished doc.)
SAHPGL-MD-04_v5 – Guideline for Classification of MD and IVDs.URL: https://www.sahpra.org.za/document/guideline-for-classification-of-medical-devices-and-ivds/ (SAHPRA)
Essential Principle Compliance – Medical_Device_IVD_Essential_Principles_Nov19_v2.URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/ (link includes Essential Principles doc) (SAHPRA)
GUIDELINE FOR MEDICAL DEVICE VIGILANCE: Adverse Events Reporting – SAHPGL-MD-03_v4.URL: https://www.sahpra.org.za/document/guideline-for-medical-device-adverse-event-reporting/ (SAHPRA)
SAHPGL-MD-11_v1 – Guideline for Completing Medical Device Adverse Event Form.URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/ (the listing page includes MD‑11 doc) (SAHPRA)
GLF-MD-11A_v1 – Medical Device Adverse Event Reporting Form.URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/ (SAHPRA)
Guideline for Completing Medical Device Adverse Event Form – SAHPGL-MD-11_v1.
Medical Device Establishment Licence Renewal Process. - https://www.sahpra.org.za/document/md031-medical-device-establishment-licence-renewal-process/ (SAHPRA)
How MC Pharma Provides Services & Consulting
As a licensed Marketing Authorisation Holder (MAH) under Section 22C of the Medicines and Related Substances Act, MC Pharma offers end-to-end regulatory consulting and compliance support for both medicines and medical devices in South Africa.
Our services include:
Regulatory Affairs Consulting – Guiding clients through SAHPRA requirements, classification, and registration strategies.
eCTD Dossier Management – Compilation, publishing, submission, and lifecycle management of regulatory dossiers.
Pharmacovigilance – Monitoring, reporting, and managing adverse events to ensure ongoing safety compliance.
Borderline Product Support – Assisting with classification assessments and preparing submissions for SAHPRA determination.
Import & Export Logistics – Managing compliant movement of medicines and devices across borders, including post-importation quality testing.
Quality Management Systems – Developing, implementing, and auditing QMS to SAHPRA standards.
Why Choose MC Pharma?
MC Pharma combines over 26 years of regulatory experience with a deep understanding of the South African pharmaceutical and medical device landscape to deliver compliant, efficient, and market-ready solutions for local and international clients.
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