SAHPRA Clarifies Import Requirements for Medical Devices Used in Exhibitions, Demonstrations and Training

Regulatory Update | November 2026

Importing medical devices into a new market isn't always about commercial distribution. Manufacturers, distributors, and healthcare organisations also bring devices into a country for exhibitions, product demonstrations, technical appraisal, or professional training.

But a temporary or non-commercial purpose doesn't automatically remove the need for regulatory authorisation.

In September 2026, the South African Health Products Regulatory Authority (SAHPRA) published a communication to industry clarifying the requirements for importing unregistered or listed medical devices for exhibition, appraisal, demonstration, or training. Identified as MD04-2026/2027, Version 1 and updated on 18 September 2026, it guides importers, exhibitors, and other applicants seeking SAHPRA approval.

What Does the Communication Cover?

It addresses the importation of medical devices, including in vitro diagnostic devices (IVDs), and unlicensed listed electronic products for specific, non-routine purposes:

Purpose	What It Involves
Exhibitions	Bringing devices in for display at industry events
Appraisal	Importing devices for assessment or evaluation
Demonstrations	Making devices available to show their features or operation
Training	Supporting professional or technical training activities

The communication is grounded in the Medicines and Related Substances Act, 1965, as amended. Its central message: applicants importing devices within this scope must seek the relevant SAHPRA approval.

Why This Matters for International Manufacturers and Distributors

South Africa can be an important market for product launches, healthcare exhibitions, distributor engagement, and professional education. These activities often involve moving equipment across borders before a product has completed the normal local regulatory process.

Without a clear grasp of the import requirements, companies can run into complications when arranging shipments or planning events, particularly when exhibiting at medical shows, demonstrating new technology to healthcare professionals, or training local partners.

Don't confuse the two routes. This specific-purpose approval is separate from ordinary importation and distribution. SAHPRA's compliance guidance identifies manufacturer and distributor establishment licences as the licences authorising ordinary medical-device imports. The September communication addresses a different, more specific context.

Who Should Pay Attention?

• International manufacturers introducing products through exhibitions, demonstrations, or training

• Local distributors and importers coordinating shipments for international manufacturers

• Exhibition organisers and event participants importing devices for temporary display or demonstration

• Healthcare training providers arranging training involving medical devices and IVDs

  
  

For all of them, regulatory planning belongs in event and shipment preparation, not at the border when the goods arrive.

What Companies Should Do

1. Identify the device's regulatory status: Determine whether the product is registered, listed, or falls within the unregistered or unlicensed categories covered by the communication.

2. Establish the purpose of importation. Be clear whether the device is for exhibition, appraisal, demonstration, or training; the activity should match the regulatory route you're considering.

3. Confirm the approval requirements. Review MD04-2026/2027 and establish the appropriate approval process before arranging shipment.

4. Coordinate with your South African representative or importer. Engage local partners early so the importation is properly assessed and responsibilities are understood.

5. Plan timelines. Factor import approval into the planning of exhibitions, demonstrations, and training programmes. Don't assume an event shipment can be processed like an ordinary commercial import.

ARQon Insight

Market access isn't only about product registration. It also means understanding the requirements that apply to different commercial and operational activities across a product's lifecycle.

SAHPRA's communication is a clear reminder: even when a device enters a market for a limited purpose, importation may still require regulatory authorisation.

For companies planning exhibitions, demonstrations, or training in South Africa, early regulatory assessment helps avoid delays and supports smoother coordination with local partners.

Key Takeaway

SAHPRA's MD04-2026/2027 communication reinforces the importance of checking import requirements before bringing unregistered or listed devices into South Africa for exhibitions, appraisal, demonstrations, or training.

For manufacturers, distributors, and event organisers, understanding the approval process is part of preparing for activity in the South African healthcare market.

Plan the regulatory side of your event as early as you plan the booth.

How ARQon Can Support You

At ARQon, we support healthcare companies navigating regulatory requirements and market-entry considerations across African markets through:

• Regulatory intelligence and monitoring

• Registration support

• Regulatory compliance guidance

  
  

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.

Official Sources

1. South African Health Products Regulatory Authority (SAHPRA): Regulatory Requirements for Importation of Unregistered or Listed Medical Devices for Exhibition, Appraisal, Demonstration, or Training (MD04-2026/2027)

2. SAHPRA: Medical Devices and In Vitro Diagnostics: Communications to Industry

3. SAHPRA : FAQs: Medical Devices Compliance