Medicines and Medical Devices Under South African Law

A Regulatory Interpretation of Scope, Classification, and Compliance Obligations

Table of Contents

1. Introduction: Why Regulatory Distinction Matters in South Africa

The distinction between medicines and medical devices in South Africa is not semantic. It is foundational to determining the applicable legal framework, regulatory pathway, evidentiary burden, licensing obligations, and post-market responsibilities. Misclassification can result in rejected submissions, unlawful market placement, enforcement action, or prolonged regulatory delays.

South Africa’s regulatory system has evolved significantly over the past decade, particularly with the expansion of oversight to medical devices and in vitro diagnostics. Organisations operating across pharmaceutical and medtech portfolios must therefore understand not only the definitions, but also the regulatory intent that underpins them.

This article provides an authoritative interpretation of how medicines and medical devices are distinguished, regulated, and supervised in South Africa, with practical implications for manufacturers, importers, distributors, and executive decision-makers.

2. South Africa’s Regulatory Architecture for Health Products

All human medicines and medical devices supplied in South Africa are regulated under the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. The Act establishes a unified legislative framework while enabling differentiated regulatory controls based on product risk and mode of action.

Key subsidiary instruments include:

  • Regulations relating to medicines and scheduled substances
  • Regulations relating to medical devices and in vitro diagnostics
  • Binding guidelines issued by the national regulator to operationalise statutory requirements

Although medicines and medical devices fall under the same primary Act, they are subject to materially different regulatory mechanisms, reflecting their distinct risk profiles and scientific bases.

3. Legal Definitions Under South African Law

3.1 What Constitutes a Medicine

Under the Medicines and Related Substances Act, a medicine is defined broadly to include any substance or mixture of substances used, or purporting to be suitable for use, in the diagnosis, treatment, mitigation, modification, or prevention of disease in humans. Crucially, medicines achieve their primary intended purpose through pharmacological, immunological, or metabolic action.

This definition captures:

  • Prescription and over-the-counter medicines
  • Biological medicines and vaccines
  • Complementary and traditional medicines where therapeutic claims are made

The defining regulatory trigger is the mechanism of action, not the dosage form or route of administration.

3.2 What Constitutes a Medical Device

A medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, reagent, software, material, or related article intended for medical purposes in humans that does not achieve its primary intended action by pharmacological, immunological, or metabolic means, although such means may assist its function.

Medical devices include:

  • Diagnostic and therapeutic equipment
  • Implants and surgical instruments
  • In vitro diagnostic medical devices
  • Software with a medical purpose

The distinction is therefore grounded in functional mode of action, not clinical application.

4. The Mandate and Role of SAHPRA

The South African Health Products Regulatory Authority is mandated to ensure that all health products marketed in South Africa meet acceptable standards of quality, safety, and effectiveness or performance.

For medicines, SAHPRA performs a full scientific assessment of quality, safety, and efficacy prior to market authorisation. For medical devices, the Authority applies a risk-based regulatory approach, focusing on safety, performance, and quality system compliance proportionate to device classification.

SAHPRA’s mandate extends beyond pre-market authorisation to include licensing of regulated entities, inspection, post-market surveillance, enforcement, and regulatory intelligence.

5. Product Classification Frameworks

5.1 Medicine Scheduling and Regulatory Consequences

Medicines are scheduled under the Act according to their potential for harm, abuse, and the level of professional oversight required. Scheduling directly affects:

  • Prescribing and dispensing controls
  • Advertising restrictions
  • Storage and record-keeping requirements

While scheduling is distinct from registration, it forms part of the overall regulatory control environment applicable to medicines.

5.2 Medical Device Risk Classification (Classes A–D)

Medical devices and in vitro diagnostics are classified according to risk, from Class A (low risk) to Class D (high risk). Classification is determined by intended purpose, duration of use, invasiveness, and impact on patient outcomes.

Risk class determines:

  • The depth of technical documentation required
  • Whether product registration is mandatory
  • The extent of post-market obligations

Incorrect classification is one of the most common causes of regulatory delay in the medical device sector.

6. Regulatory Authorisation Pathways

6.1 Medicine Registration Pathway

All medicines must be registered with SAHPRA before they may be marketed or supplied in South Africa. Registration requires submission of a comprehensive Common Technical Document dossier covering:

  • Administrative and prescribing information
  • Quality and manufacturing data
  • Non-clinical and clinical evidence

Approval is product-specific and results in the issuance of a certificate of registration.

6.2 Medical Device Licensing and Registration Pathway

Medical device regulation follows a staged approach:

  1. Establishment licensing for manufacturers, importers, and distributors
  2. Product registration for devices falling within specified risk classes
  3. Import and distribution controls

Lower-risk devices may be exempt from product registration but remain subject to licensing and post-market obligations.

7. Quality, Safety, and Performance Expectations

7.1 Medicines: Quality, Safety, and Efficacy

Medicines are assessed on the basis of demonstrated quality, safety, and therapeutic efficacy. Evidence is generated through preclinical and clinical studies, supported by validated manufacturing processes and pharmacovigilance systems.

7.2 Medical Devices: Quality, Safety, and Performance

Medical devices are assessed for safety and performance relative to their intended purpose. Compliance with recognised quality management standards, particularly ISO 13485, forms the backbone of regulatory assurance.

8. Establishment Licensing and Authorised Activities

Both medicine and medical device activities require licensed establishments. Licences are activity-specific and may include manufacturing, importing, exporting, distributing, or wholesaling. Operating outside the scope of a granted licence constitutes non-compliance.

9. Post-Market Obligations and Lifecycle Compliance

Regulatory approval is not the end of compliance. Post-market obligations include:

  • Pharmacovigilance for medicines
  • Vigilance and field safety corrective actions for medical devices
  • Variation management, renewals, and record retention

SAHPRA places increasing emphasis on post-market oversight as a measure of regulatory maturity.

10. Practical Implications for Manufacturers, Importers, and Distributors

Organisations must align internal structures, quality systems, and regulatory strategies with the correct product category. Portfolio businesses must often manage parallel regulatory pathways with distinct compliance calendars and risk profiles.

11. Common Regulatory Errors and Misclassification Risks

Frequent errors include:

  • Treating software-enabled products as non-regulated tools
  • Assuming international approvals automatically translate to South Africa
  • Applying medicine-style evidence expectations to devices, or vice versa

Each error has direct operational and commercial consequences.

12. Strategic Considerations for Market Entry and Portfolio Management

Early regulatory strategy informs:

  • Time to market
  • Cost of compliance
  • Partner selection and distribution models

Regulation should be integrated into commercial planning, not treated as an afterthought.

13. Frequently Asked Questions

Is the distinction between a medicine and a medical device based on intended use or mechanism of action?

The distinction is primarily based on the mechanism of action. Intended use informs classification, but regulatory categorisation hinges on whether the primary effect is pharmacological, immunological, or metabolic.

Can a product be regulated as both a medicine and a medical device?

Certain combination products may contain both elements. In such cases, SAHPRA determines the primary mode of action to assign the dominant regulatory pathway.

Do all medical devices require product registration in South Africa?

No. Product registration depends on risk classification. However, all parties involved in manufacturing, importing, or distribution must be licensed.

Is ISO 13485 mandatory for medical device companies?

While not explicitly mandated in all cases, alignment with ISO 13485 is effectively expected as the recognised quality framework for medical device regulation.

How long does SAHPRA approval typically take?

Timelines vary based on product type, dossier completeness, and regulatory backlog. Incomplete or misclassified submissions significantly extend review periods.

Can foreign manufacturers interact directly with SAHPRA?

Foreign entities must operate through a locally licensed establishment or appointed in-country regulatory representative.

How GH Strategies Can Support Your Regulatory Pathway

GH Strategies provides structured, end-to-end regulatory support across both pharmaceutical and medical device portfolios. Our work is grounded in South African law, regulatory practice, and lifecycle compliance principles.

We support clients with:

  • Medicine registration, CTD and eCTD dossier compilation, and lifecycle management
  • Medical device classification, establishment licensing, and product registration
  • Quality management system alignment for GMP, GDP, and ISO 13485
  • Regulatory intelligence, post-market compliance, and ongoing engagement with SAHPRA

Our role is to act as a long-term regulatory partner, enabling compliant market entry, sustained authorisation, and regulatory resilience over the full product lifecycle.

References

  1. Republic of South Africa (1965) Medicines and Related Substances Act 101 of 1965, as amended. Pretoria: Government Printer. Available at: SAHPRA-hosted consolidated Act (Government Gazette 40869, 26 May 2017).
  2. Republic of South Africa (2016) Medicines and Related Substances Act, 1965: Regulations, Government Notice R.1515, Government Gazette No. 40480, 9 December. Pretoria: Government Printer. Available at: Gov.za PDF
  3. South African Health Products Regulatory Authority (SAHPRA) (n.d.) Medical Devices. Pretoria: SAHPRA. Available at: SAHPRA Medical Devices Unit page
  4. South African Health Products Regulatory Authority (SAHPRA) (2019) Classification of Medical Devices and IVDs (Guideline). Pretoria: SAHPRA. Available at: PDF
  5. South African Health Products Regulatory Authority (SAHPRA) (n.d.) Guideline for Classification of Medical Devices and IVDs. Pretoria: SAHPRA. Available at: Web page
  6. South African Health Products Regulatory Authority (SAHPRA) (2023) Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices and IVDs (SAHPGL-MD-06 v3, 8 March). Pretoria: SAHPRA. Available at: PDF
  7. South African Health Products Regulatory Authority (SAHPRA) (2023) Guideline on Questions and Answers: Licensing of Medical Device Establishments (SAHPGL-MD-07 v3, 17 November). Pretoria: SAHPRA. Available at: PDF
  8. South African Health Products Regulatory Authority (SAHPRA) (2019) Guidance for the Submission of the South African CTD/eCTD: General and Module 1 (May). Pretoria: SAHPRA. Available at: PDF
  9. South African Health Products Regulatory Authority (SAHPRA) (n.d.) General, eCTD and Human Medicines Guidelines. Pretoria: SAHPRA. Available at: Web page
  10. South African Health Products Regulatory Authority (SAHPRA) (2025) SAHPRA eCTD Specification 3.1 and Guidance for Module 1 and Regional Information (Guideline, 9 October). Pretoria: SAHPRA. Available at: Web page
  11. Medicines Control Council (MCC) (2014) Pharmaceutical and Analytical CTD/eCTD (Guideline). Pretoria: MCC. Available at: PDF (SAHPRA library)
  12. International Organization for Standardization (ISO) (2016) ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. Geneva: ISO.