South Africa's Guidance: Medical Devices Reliance Guideline & ZAZIBONA Centralised Procedure: Strengthening Regional Regulatory Harmonisation
- Sharan Murugan
- 2 hours ago
- 3 min read
South Africa continues to strengthen regulatory efficiency and regional collaboration through structured reliance pathways. The SAHPRA Medical Devices Reliance Guideline and the ZAZIBONA Centralised Procedure – SAHPRA’s Reliance Process collectively demonstrate SAHPRA’s commitment to regulatory convergence within the SADC region.
The Medical Devices Reliance Guideline outlines the principles and procedures for reliance-based review in both pre-marketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs).
The guideline defines how SAHPRA may rely on assessments performed by trusted regulatory authorities while maintaining independence and accountability for final decisions. It applies across multiple regulatory functions, including:
Establishment licensing
Product registration
Clinical trial approvals
ISO 13485 audits
Post-marketing surveillance
Importation for donation, appraisal, and exhibition
SAHPRA reserves the right to request additional information where necessary to confirm safety, quality, and performance.
Principles of Reliance
SAHPRA aligns its reliance practices with internationally recognised principles to ensure regulatory integrity:
Universality – Reliance may be applied by authorities at different maturity levels.
Sovereignty of decision-making – SAHPRA retains independent authority over final decisions.
Transparency – Processes must be predictable and clear.
Respect for legal frameworks – Reliance must align with national legislation.
Consistency – Similar products and processes are handled uniformly.
Competence – Both the relying authority and referenced authority must operate within robust regulatory systems.
These principles ensure that reliance enhances efficiency without compromising public health safeguards.
Reliance Pathways for Medical Devices and IVDs
SAHPRA identifies four main reliance pathways:
1. Abridged Review
This pathway allows streamlined review where a product has already been evaluated and approved by a Recognised Regulatory Authority (RRA), WHO Listed Authority (WLA), or under continental initiatives such as AMRH/AMA. SAHPRA focuses on confirming product sameness and country-specific considerations.
2. Recognition
Recognition involves accepting regulatory decisions or audit outcomes from trusted authorities, including reliance on ISO 13485 certifications and MDSAP audit reports.
3. Work Sharing / Joint Assessment
Under this collaborative approach, SAHPRA participates in joint reviews with other regulatory authorities, particularly within continental harmonisation initiatives.
4. Verification
Verification ensures that the product submitted to SAHPRA is identical to the product previously approved by the reference authority. The manufacturer must confirm sameness and provide consistent documentation.
Application Across Regulatory Functions
Establishment Licensing
SAHPRA uses the verification pathway for issuing medical device establishment licences, relying on recognised Conformity Assessment Bodies for ISO 13485 audits.
Product Registration
For Class B, C, and D medical devices (including IVDs), reliance pathways may be applied depending on prior approvals. SAHPRA verifies sameness and may conduct abridged reviews or recognition assessments where appropriate.
Clinical Trials
SAHPRA considers the regulatory status of clinical investigations approved by recognised authorities, particularly in multi-centre trials. Compliance with Good Clinical Practice standards supports decision-making.
Post-Market Surveillance
Reliance may also extend to post-market safety communications and international vigilance data to monitor ongoing benefit–risk profiles.
The guideline remains valid for five years from its effective date.
In February 2026, SAHPRA issued a Communication to Stakeholders outlining how it will rely on assessments conducted under the ZAZIBONA Centralised Procedure.
ZAZIBONA is a regional collaborative initiative within the Southern African Development Community (SADC) aimed at enhancing harmonisation and improving timely access to quality, safe, and effective health products.
Overview of the ZAZIBONA Reliance Process
Under this pathway:
Applications may only be submitted to SAHPRA after a positive recommendation has been issued by ZAZIBONA.
SAHPRA relies on ZAZIBONA’s scientific assessment to facilitate a more efficient national review process.
SAHPRA retains the authority to request additional information if needed to confirm safety, efficacy, and quality.
This process supports regulatory convergence while maintaining national oversight.
Key Submission Requirements
Applicants submitting under the ZAZIBONA reliance pathway must:
Include a copy of the positive recommendation letter issued by ZAZIBONA.
Update the dossier to reflect any recommendations or conditions stipulated by ZAZIBONA.
Importantly, parallel submissions to SAHPRA and ZAZIBONA are not permitted. Applicants must wait for the ZAZIBONA outcome before filing with SAHPRA.
Timelines
Once a valid application is received, supported by a positive ZAZIBONA recommendation, SAHPRA aims to finalise assessment and issue a registration decision within 90 working days after screening has been completed.
This defined timeline enhances predictability and supports faster access to approved health products.
Regulatory Impact and Strategic Significance
Together, the Medical Devices Reliance Guideline and the ZAZIBONA reliance process reflect SAHPRA’s strategic shift toward:
Regional harmonisation
Reduced duplication of regulatory work
Optimised resource utilisation
Accelerated access to safe and effective products
By leveraging trusted regulatory decisions while maintaining sovereignty, SAHPRA balances efficiency with robust public health protection.
Applicants intending to use these reliance pathways should ensure strict compliance with submission requirements and alignment with the applicable procedural framework.
References
For more details on these guidance documents, please click the respective links below to access the full official publications. Medical Devices Reliance Guideline (SAHPGL-MD-22_v1, 25 February 2026)
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