South Africa Releases Updated Clinical Evaluation Guideline for Medical Devices

South Africa has taken a significant step forward in strengthening its medical device regulatory framework. On 9 September 2025, the South African Health Products Regulatory Authority (SAHPRA) published the Guidelines on Clinical Evaluation of Medical Devices (SAHPGL-MD-16_v1). This long-anticipated update brings more clarity, structure, and global alignment to how manufacturers must demonstrate clinical evidence.

This updated guideline is designed to modernise South Africa’s clinical evaluation framework and ensure that devices entering the market meet international expectations for safety, performance, and benefit–risk balance. For manufacturers eyeing the South African market, this marks a key regulatory shift worth paying close attention to.

A More Structured Approach to Clinical Evidence

SAHPRA’s new guideline lays out a clearer and more systematic roadmap for conducting clinical evaluations. It introduces strengthened principles for planning, selecting data, validating sources, and documenting conclusions.

Among the most important updates:

• Stronger planning requirements for how clinical evaluations must be designed, including defining the device’s intended purpose and identifying the appropriate evidence.

• Clearer recognition of accepted data sources, such as literature, clinical trials, post-market surveillance, and comparable devices, offering flexibility while maintaining rigour.

• Alignment with global standards, including ISO 14155 (clinical investigations) and ISO 14971 (risk management), ensures South Africa’s framework moves closer to established international practices.

A More Robust Clinical Evaluation Report (CER)

One of the key enhancements is the requirement for a structured, well-evidenced Clinical Evaluation Report (CER).

Manufacturers must now present a transparent analysis showing:

• how the available evidence supports the device’s safety and performance

• how benefits outweigh known risks

• how traceability is maintained throughout the evaluation process

• how the evidence will be updated over time as part of ongoing lifecycle management

  
  

This emphasis on continuous evaluation reflects a global shift: clinical evidence is no longer a “once and done” process.

Why This Matters for the Industry

The release of this guideline has meaningful implications:

• Global competitiveness: South Africa’s framework now aligns more closely with international requirements, easing future regulatory harmonisation.

• Higher expectations for documentation: Manufacturers must ensure their CER processes meet SAHPRA’s strengthened standards.

• Improved patient safety: A more rigorous evidence framework contributes to safer and more effective medical devices entering the market.

For companies planning market entry or renewal in South Africa, now is the time to review and update your clinical evaluation strategy to ensure compliance.

Looking Ahead

South Africa’s updated clinical evaluation guideline reflects its commitment to regulatory maturity, patient protection, and international convergence. As global markets continue to tighten evidence expectations, SAHPRA’s move positions the country as a stronger, more credible player in the medical device ecosystem.

Manufacturers, authorised representatives, and regulatory teams should assess this guideline carefully and adjust their submissions accordingly.

Source: South African Health Products Regulatory Authority (SAHPRA)