Understanding SAHPRA’s New Reliance Pathway for Device Approvals

On November 5, 2025, the South African Health Products Regulatory Authority (SAHPRA) released its Medical Devices Reliance Guideline for public comment, a document that signals a major modernization in how South Africa evaluates medical devices and IVDs. Although the stated implementation date is October 31, 2025, SAHPRA has positioned the guideline to remain valid for five years once finalized, offering manufacturers and regulatory teams a more predictable path for planning market entry and lifecycle management.

At its core, the guideline formalizes a reliance-based framework that allows SAHPRA to leverage evaluations, decisions, and data from trusted regulatory partners. This mirrors global regulatory trends: more efficiency, more harmonization, and smarter use of existing evidence, without compromising sovereign decision-making.

For companies looking to enter or maintain presence in the South African market, understanding this framework is essential. Below is a breakdown of how the reliance system is structured, what SAHPRA expects, and how to prepare your regulatory strategy accordingly.

Why SAHPRA Is Moving Toward Reliance

The guideline sets out to clearly define how reliance mechanisms will support the evaluation of medical devices and IVDs across both pre-market and post-market activities. This spans routine listing, ISO 13485 auditing, pre-marketing assessments, product registration, risk classification, and post-market surveillance.

Not everything falls under the reliance umbrella. SAHPRA excludes Class A devices that are non-measuring and non-sterile, devices with no prior approval from a Recognised Regulatory Authority (RRA), and products reviewed under emergency pathways, which are governed by a separate guideline.

Still, for the majority of moderate- and high-risk devices, reliance offers meaningful opportunities to accelerate access.

Legal Foundations Behind the Guideline

SAHPRA’s reliance framework draws its authority from the Medicines and Related Substances Act 101 of 1965 and the Medical Devices and IVD Regulations (No. 40480). By grounding reliance activities in existing legislation, the agency ensures its processes are enforceable, consistent, and aligned with South Africa’s broader regulatory landscape.

Principles That Guide SAHPRA’s Reliance Model

SAHPRA’s approach is built on globally recognized principles:

• Universality: Aligned with international best practices
• Transparency: Clarity in process and documentation
• Sovereignty: Maintaining decision-making authority
• Respect for legal/regulatory context: Ensuring alignment with national laws
• Consistency: Predictable requirements and assessments
• Competence: Leveraging qualified evaluators and trusted external evidence

These principles echo WHO Good Reliance Practices and IMDRF concepts, reinforcing SAHPRA’s commitment to strengthening regulatory performance while avoiding duplication of work already completed by trusted authorities.

The Four Reliance Pathways Recognized by SAHPRA

Like many regulators adopting reliance, SAHPRA lists four primary models:

1. Abridged Review: SAHPRA conducts a condensed evaluation that focuses only on local-context considerations when a reputable regulator has already completed a full review.
2. Recognition: SAHPRA may accept, either fully or partially, decisions, certificates, or reports issued by an RRA or WHO.
3. Work-Sharing / Joint Review: SAHPRA collaborates with other authorities to jointly assess submissions.
4. Verification: SAHPRA confirms that the device is identical to one already approved by an RRA.

The guideline repeatedly underscores that SAHPRA will select the most appropriate mechanism depending on the type and risk class of the submission.

How SAHPRA Applies Reliance Across Regulatory Activities

1. Listing of Medical Devices / IVDs (Establishment Licensing)

For listing, SAHPRA primarily uses a verification-based approach. Manufacturers must provide:

• ISO 13485 certification issued by a recognized conformity assessment body
• Evidence of “sameness” for Class C and D devices, confirming they match products approved by trusted regulatory authorities

The emphasis on sameness aligns South Africa’s listing requirements with global pathways like those adopted in Kenya, Rwanda, and Botswana.

2. Product Registration

Reliance plays its largest role in product registration for Class B, C, and D devices. SAHPRA requires the standard dossiers aligned with MD-09 (IVD) and MD-10 (non-IVD), but integrates reliance pathways in several ways:

• Verification remains a foundational requirement applicants must demonstrate equivalence to the reference product approved elsewhere.
• Abridged Review is available for devices already approved by RRAs, WHO Prequalification, or other trusted authorities.
• Recognition may be applied to MDSAP audit reports, regional harmonization initiatives (AMA/AMRH), and quality system certifications.

This creates a hybrid model that still expects robust documentation but rewards applicants with trusted approvals.

3. Clinical Trials

For clinical trial applications, SAHPRA will consider:

• Regulatory status of the study in other markets
• Participation in multinational trials
• Decisions and data from RRAs

While SAHPRA still performs its own assessment, external data can significantly streamline the process.

4. Post-Market Surveillance (PMS)

SAHPRA will leverage:

• PMS data and safety signals from RRAs
• WHO surveillance resources
• Documentation already submitted to trusted authorities

However, SAHPRA maintains the right to request additional South Africa-specific PMS evidence when necessary.

How SAHPRA Positions Itself Globally

The guideline doesn’t exist in isolation, it intentionally aligns South Africa with:

• WHO Good Reliance Practices
• IMDRF frameworks and terminology
• Regional reliance guidelines adopted by Kenya, Botswana, Rwanda, and others

This alignment strengthens harmonization and positions South Africa as an increasingly predictable regulatory environment for manufacturers operating across Africa.

What This Means for Industry Stakeholders

For manufacturers, distributors, and regulatory affairs teams, the implications are clear:

• Potentially shorter timelines for market entry
• Reduced duplication of assessments when strong external evidence exists
• More predictable expectations, particularly around documentation

But reliance is not automatic. SAHPRA expects:

• Prior approvals from trusted RRAs or WLAs
• Clear evidence of sameness
• Valid ISO 13485 certification
• A robust PMS system
• Clean alignment with dossier requirements in MD-09 and MD-10

SAHPRA also reiterates its full sovereignty, reliance supports decisions, but does not replace them.

How Applicants Should Prepare

Regulatory teams planning submissions under the reliance model should:

1. Confirm existing approvals from RRAs/WLAs early in the planning cycle.
2. Assemble equivalence/sameness evidence with clarity and traceability.
3. Structure dossiers according to MD-09 / MD-10, paying attention to formatting and completeness.
4. Monitor consultation updates, as the guideline is currently open for public comment.

Ensure PMS and quality system documentation aligns with SAHPRA expectations, especially if leveraging MDSAP or WHO data.

Challenges Manufacturers May Face

Despite the advantages, several hurdles may arise:

• Clearly demonstrating “sameness”; often the most complex component
• Determining whether an authority qualifies as an RRA
• Providing adequate PMS evidence for high-risk devices
• Adapting existing global dossiers to SAHPRA’s specific reliance pathways
• Navigating exclusions for Class A non-measuring, non-sterile devices

Understanding these challenges early helps applicants refine their regulatory strategy before submission.

Conclusion

SAHPRA’s Medical Devices Reliance Guideline represents a major step forward for South Africa’s regulatory ecosystem. By aligning with global reliance principles and international best practices, SAHPRA is fostering a more efficient, predictable environment for bringing safe, effective medical technologies to the South African market.

For manufacturers seeking to accelerate access while reducing regulatory burden, this guideline offers valuable new pathways, but success will depend on careful preparation, strong evidence packages, and well-structured submissions.

If you’d like help interpreting this guideline or preparing SAHPRA-ready dossiers, RegDesk’s regulatory intelligence and submission platform can support you at every stage.