Definition of a Medical Device under the Medicines Act

1. Key takeaways

The statutory definition of a medical device in South Africa is set out in the Medicines and Related Substances Act, Act No. 101 of 1965. Under that definition, a medical device means any instrument, apparatus, appliance, machine, implement, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and Group IV hazardous substances under the Hazardous Substances Act, 1973 (Act No. 15 of 1973), intended by the manufacturer to be used, alone or in combination, for humans or animals for any of 7 specified purposes, and whose primary intended action is not achieved by pharmacological, immunological or metabolic means (although it may be assisted by such means). IVDs are not a separate category; they are contained within the device definition itself. This single definitional choice drives the entire downstream architecture: licensing scope, registration expectations, the treatment of software and AI products, veterinary devices, and the interface with radiation control licensing all follow from how this definition is read and applied.

2. Legal basis

3. Expert insights

Insight one: the 7 intended purposes are alternatives, and matching any one of them is sufficient. The statutory list covers: (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (iii) investigation, replacement or modification of the anatomy or of a physiological process; (iv) sustaining or supporting life; (v) control of conception; (vi) disinfection of medical devices; and (vii) provision of medical or diagnostic information by means of in vitro examination of specimens derived from the human body. Subparagraph (vii) is precisely the statutory landing point for IVDs: they sit inside the definition, not outside it, so no separate registration channel needs to be imagined.

Insight two: the exclusion of pharmacological, immunological or metabolic means is the watershed between device and medicine. The definition excludes products whose primary intended action is achieved by those means, but permits their function to be assisted by such means. This boundary attracts the most dispute in practice: drug-device combinations, products incorporating biological materials and drug-eluting devices all require argumentation on this exact sentence. Combination devices also have a dedicated field in the registration application form, requiring the name and quantity of each scheduled substance or biological substance they contain, so the analysis must be documented well before any form is completed.

Insight three: software is written into the definition, so no separate argument is needed. The word software in the definition places standalone software (SaMD) naturally within the device category. This explains why SAHPRA was able, on 19 August 2025, to issue a communication (MD08-2025/2026) requiring AI and ML devices to be authorised before being placed on the market — the definition did not need to be widened first, because it had always covered such products. Developers of algorithmic tools should therefore plan for authorisation from the first design review.

Insight four: the definition covers animals as well as humans. The definition refers to use for humans or animals. Veterinary devices are therefore also regulated by SAHPRA, and SAHPRA issued MD05-2025/2026 on 21 June 2025 to set out its requirements expressly. Companies making animal diagnostics often assume they fall outside device law; this is a costly misjudgment, because the veterinary requirements are enforced with the same definitional foundation as human-device requirements.

Insight five: Group III and IV hazardous substances are folded into the device definition. This arrangement brings certain articles with hazardous properties (such as radioactive or toxic items) into the device track, creating an interface with the Radiation Control licensing regime. Radiation-emitting equipment in South Africa therefore naturally sits under the dual jurisdiction of the device establishment licence plus the Radiation Control licence, and the two approvals should be planned together from the outset rather than sequenced one after the other.

4. Practical recommendations

1. Assess the 7 intended purposes first, then the exclusion clause: the order must not be reversed.
2. Manage IVDs as devices; do not look for a separate channel: apply Notice 1515 and the IVD rules of SAHPGL-MD-04.
3. Argue drug and combination products separately: prepare documentation on the pharmacological mechanism of action.
4. Bring software and AI and ML products into scope proactively: cross-check MD08-2025/2026.
5. Treat veterinary devices as requiring authorisation too: cross-check MD05-2025/2026.
6. Schedule dual licences for radiation products in advance.

5. Verification checklist

• □ Verify product attributes item by item against the definition in Act 101 of 1965
• □ Verify which of the 7 intended purposes the product matches
• □ Verify that the primary intended action is not achieved by pharmacological, immunological or metabolic means
• □ Verify whether the product is an IVD (definition subparagraph (vii))
• □ Verify whether the product contains software or is standalone software
• □ Verify whether the product is for animal use (triggering veterinary device requirements)
• □ Verify whether Group III or IV hazardous substances or radiation are involved
• □ Verify that combination products have documentation of the names and quantities of scheduled or biological substances

Regulatory information verified as of 29 October 2026. The instruments, guidelines and effective dates described in this article are limited to the content published by the official sources listed under the legal basis above as at that date; where official documents are updated, the latest published version prevails.

• South Africa local support: GRZAN assists manufacturers in the Chinese mainland and abroad with SAHPRA Medical Device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) arrangements, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification decisions, technical documentation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway arguments, technical documentation and essential principles conformity arguments, labelling and instructions for use localisation in English, and post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.