South Africa Med Dev Guidance: Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments

Sharan Murugan
2 hours ago
2 min read

The South African regulatory framework for medical devices is strengthening its oversight to ensure full accountability across the supply chain, particularly when activities are outsourced to third parties. The South African Health Products Regulatory Authority (SAHPRA) has clarified that outsourcing does not reduce regulatory responsibility and that all parties involved must comply with licensing requirements.

The guidance Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments was issued on 8 April 2026, outlining the obligations of manufacturers, distributors, and wholesalers when engaging third parties for activities such as manufacturing, packaging, distribution, or servicing.

This guidance applies to all stakeholders involved in outsourced or contracted activities across the medical device lifecycle. It includes manufacturers, importers, distributors, wholesalers, and service providers who engage third parties for activities such as sterilisation, packaging, maintenance, refurbishment, or distribution.

The requirements apply regardless of whether the activity is performed internally or outsourced, ensuring consistent regulatory compliance across all operational models.

Licensing Requirements

All entities involved in manufacturing, distribution, or wholesaling activities must obtain a valid medical device establishment licence before conducting operations. This requirement applies equally to third parties performing outsourced activities.

The regulatory framework clearly states that no entity may manufacture, distribute, or act as a wholesaler of medical devices or IVDs without holding the appropriate licence. Licensing ensures that all parties meet established standards for quality assurance and regulatory compliance.

Outsourced Manufacturing Activities

When manufacturing-related activities such as sterilisation, packaging, labelling, assembly, reprocessing, or refurbishment are outsourced, the contracted party is considered part of the manufacturing process and must hold a manufacturer's licence.

These activities are classified as critical processes that directly impact product quality and safety, and therefore must be conducted in accordance with ISO 13485 quality management systems.

Even when outsourcing is involved, the original manufacturer retains overall responsibility for the product and must ensure that the third party is properly qualified and integrated into its quality management system.

Maintenance, Repair, and Modification

Activities such as maintenance, servicing, repair, or modification of medical devices are also considered regulated manufacturing-related activities.

If a third party performs these services, they must hold a manufacturer's licence and ensure that the device continues to meet its original safety and performance specifications.

In cases where modifications significantly alter the device’s intended purpose or performance, the modified product may be considered a new medical device, requiring separate regulatory consideration and responsibility.

Import and Packaging Scenarios

When imported devices are relabelled, repackaged, or assembled locally, these activities are treated as manufacturing operations.

Entities performing such activities must hold a manufacturer licence, and the entity placing the product on the market is responsible for ensuring that labelling reflects the correct local licence holder information.

Secondary packaging and labelling are therefore not administrative tasks but regulated manufacturing activities.

Distribution Activities

Distributors involved in importing and supplying medical devices must hold a distributor licence and ensure compliance with quality management standards.

When distribution activities are outsourced, both the contracting entity and the third party must be appropriately licensed, maintaining traceability and accountability throughout the supply chain.