SAHPRA Medical Device Reliance in South Africa

Regulatory reliance is becoming increasingly important for manufacturers seeking to place medical devices and in vitro diagnostic medical devices, or IVDs, on the South African market.

On 25 February 2026, the South African Health Products Regulatory Authority, SAHPRA, published SAHPGL-MD-22, Medical Devices Reliance Guideline, establishing a dedicated framework for reliance-based regulatory review of medical devices and IVDs.

The guideline covers both pre-market and post-market regulatory activities and identifies establishment licensing, product registration, clinical trial approvals, ISO 13485 audits, post-market surveillance, market surveillance and certain importation pathways among the areas where reliance may be applied.

For international manufacturers, this is significant. A device that has already undergone regulatory assessment in another jurisdiction may carry regulatory evidence that SAHPRA can take into account rather than unnecessarily repeating every aspect of work already performed by another trusted authority.

However, reliance does not mean automatic South African approval.

SAHPRA remains responsible for the regulatory decision in South Africa and may request additional information where necessary to establish the safety, quality and performance of a medical device or IVD.

What is regulatory reliance for medical devices?

Regulatory reliance is an approach under which one regulatory authority takes into account and gives significant weight to regulatory work already performed by another trusted authority or institution when making its own decision.

The principle allows authorities to use existing regulatory expertise and outputs more efficiently instead of unnecessarily repeating assessments that have already been completed by competent authorities.

The important point is that reliance does not transfer regulatory responsibility.

The relying authority remains accountable for its own decision.

That principle is reflected in SAHPRA’s approach. The Authority may use evaluations, decisions and other regulatory information generated elsewhere, but SAHPRA retains responsibility for the South African regulatory outcome.

For manufacturers, reliance should therefore be understood as an alternative regulatory review approach, not as an exemption from South African regulation.

For the broader legal and regulatory context, see Medical Devices and IVDs in South Africa: The Regulatory Framework Explained.

Why has SAHPRA introduced a medical device reliance pathway?

Medical-device regulation is increasingly complex.

Regulators must assess products ranging from basic consumables and diagnostic tests to implantable devices, software, connected technologies and high-risk diagnostic platforms.

Many of these products have already undergone significant regulatory assessment in other markets.

Reliance allows regulatory authorities to make use of appropriate existing assessments while directing more resources toward regulatory activities that require national attention.

SAHPRA’s dedicated medical-device reliance framework also forms part of the wider development of South Africa’s product-registration system.

In March 2026, SAHPRA published the final Medical Devices Registration Feasibility Study Report to support development of a comprehensive and risk-based approach to medical-device and IVD registration.

Reliance therefore forms part of a broader regulatory transition rather than being an isolated policy.

Our guide to medical device registration in South Africa explains how the developing registration system fits into the current regulatory framework.

Where can SAHPRA use regulatory reliance?

SAHPRA’s reliance framework applies to both pre-marketing and post-marketing regulatory activities.

The Authority identifies areas including:

medical device establishment licensing;
product registration;
clinical trial approvals;
ISO 13485 audits;
post-marketing activities;
market surveillance; and
certain regulatory importation activities such as donations, exhibitions and appraisals.

The framework applies to medical devices as well as IVDs.

This means reliance should not be viewed purely as a future registration mechanism. Regulatory assessments, quality-system audits, clinical evidence and post-market information generated elsewhere may become relevant depending on the particular SAHPRA process.

Does reliance mean automatic SAHPRA approval?

No.

A manufacturer cannot assume that a device approved by another regulator is automatically approved for sale in South Africa.

Reliance means SAHPRA may use the work of another authority in reaching its decision. It does not remove SAHPRA from the decision-making process.

South African requirements also continue to apply.

Depending on the circumstances, these can include establishment licensing, local device classification, appointment of an Authorised Representative, product listing, quality-system requirements, technical documentation, South African labelling requirements and vigilance obligations.

A foreign approval is therefore a regulatory asset, not a substitute for a South African regulatory strategy.

This distinction is particularly important for international manufacturers planning medical device market entry into South Africa.

Reliance is the broader principle of using regulatory work performed by another trusted authority or institution when making a national regulatory decision.

Recognition generally goes further and involves accepting another authority’s regulatory decision within a defined framework.

Work-sharing or joint assessment involves regulators actively collaborating to perform regulatory work rather than one authority using work that another regulator has already completed.

These approaches can reduce duplication, but they are not interchangeable.

For manufacturers, the practical question is therefore not simply whether the device has been approved somewhere else.

The more useful questions are which authority issued the approval, what was assessed, which product was assessed and whether the resulting regulatory work can appropriately support the South African decision.

Why device sameness matters

Reliance only works properly when SAHPRA can understand the relationship between the device submitted in South Africa and the device assessed elsewhere.

A foreign approval has limited regulatory value if it applies to a materially different product.

Relevant considerations may include:

manufacturer identity;
product or trade name;
model and catalogue numbers;
intended purpose;
indications for use;
device design;
risk classification;
software version where applicable;
manufacturing sites;
critical components;
sterilisation method;
labelling;
instructions for use; and
approved variants or configurations.

Differences do not necessarily mean reliance is impossible, but they need to be identified and assessed.

Manufacturers should therefore maintain strong change-control and regulatory-history records rather than relying solely on a foreign approval certificate.

Verion Medical’s technical documentation and labelling support can form part of this readiness assessment.

Which foreign approvals may support a reliance pathway?

Manufacturers frequently ask whether FDA clearance, European CE certification or approval in another jurisdiction is sufficient for SAHPRA reliance.

There is no universal answer based on the certificate alone.

SAHPRA has already demonstrated through its Medical Device Registration Voluntary Feasibility Study how foreign regulatory evidence may support a reliance approach.

The feasibility-study criteria considered originating approvals from regulatory systems including Australia, Brazil, Canada, Europe, the United States and WHO prequalification for applicable IVDs, together with appropriate conformity-assessment evidence.

The feasibility study should not be interpreted as meaning that every certificate from those jurisdictions automatically qualifies every product for reliance.

It does demonstrate the type of prior regulatory scrutiny that can be relevant when SAHPRA considers reliance-based product review.

International manufacturers should therefore preserve both the final regulatory approval and the supporting regulatory history demonstrating what was assessed.

Reliance and medical device establishment licensing

The Medical Devices Reliance Guideline expressly includes establishment licensing within its scope.

Reliance does not remove the need for the appropriate South African establishment licence.

Companies should continue to establish which South African entity will perform regulated activities, whether the entity requires a manufacturer, distributor or wholesaler licence, which products fall within the proposed scope and who will act as the Authorised Representative.

Our SAHPRA Medical Device Establishment Licence guide explains these requirements separately.

Verion Medical also supports medical device establishment licensing for companies establishing or modifying regulated operations in South Africa.

Reliance, ISO 13485 and conformity assessment

Quality-system evidence is another important part of the reliance framework.

SAHPRA specifically identifies ISO 13485 audits as an area where regulatory reliance may be applied.

International manufacturers may already have undergone extensive quality-system audits by accredited or recognised conformity assessment organisations.

However, the certificate itself still needs to be appropriate.

Relevant considerations can include the identity of the certificate holder, manufacturing site, certification scope, device categories, certification body, validity period and relationship between the certificate scope and the products intended for South Africa.

Manufacturers should therefore ensure that their ISO 13485 documentation is current, traceable and consistent with their South African regulatory submission.

For the wider South African requirements, see ISO 13485 in South Africa: Requirements for Medical Device Companies and Verion Medical’s ISO 13485 and Quality Management Systems services.

Reliance and medical device registration

The long-term importance of reliance becomes particularly clear when considering product registration.

South Africa has an established legislative basis for medical-device registration, while SAHPRA continues to develop the broader operational registration framework.

The voluntary registration feasibility study tested both a reliance pathway and a South African assessment pathway.

Products with appropriate originating approvals and conformity-assessment evidence could enter the reliance pathway tested during the study.

The February 2026 reliance guideline provides another important component of the developing registration structure.

Manufacturers planning future registrations should therefore organise foreign regulatory approvals, assessment history, technical documentation, quality-system evidence and product sameness records before a future registration call-up becomes a commercial deadline.

Our medical device registration services support companies preparing for current requirements and the developing registration framework.

What the SAHPRA registration feasibility study tells manufacturers

The registration feasibility study provides practical insight into how reliance can operate in product review.

The eligibility framework considered factors such as foreign authorisation, conformity assessment, ISO 13485 certification, South African classification, technical documentation and an originating regulatory approval.

The study therefore reinforces a critical lesson:

Reliance reduces unnecessary duplication, but it does not eliminate the dossier.

Manufacturers still need organised regulatory evidence.

Reliance works best where SAHPRA can clearly understand what another regulator assessed, identify the product involved and determine whether that assessment appropriately supports the South African regulatory decision.

Reliance in clinical investigations and post-market regulation

SAHPRA’s reliance framework is not limited to initial market entry.

The guideline includes clinical trial approvals, post-marketing activities and market surveillance.

Relevant international information may therefore include clinical investigation results, adverse events, field safety corrective actions, recalls, safety notices, post-market surveillance information and significant regulatory decisions taken elsewhere.

A manufacturer supplying products internationally should maintain a regulatory intelligence process capable of identifying information from other jurisdictions that may also have relevance for South Africa.

What international manufacturers should prepare

The documentation required will depend on the specific regulatory activity, but a reliance-readiness package may include:

evidence of the foreign regulatory approval;
details of the issuing authority;
evidence identifying the exact approved device;
regulatory assessment reports where available;
the current technical dossier;
device classification;
risk-management documentation;
verification and validation evidence;
clinical or performance evidence;
current ISO 13485 certification;
conformity-assessment information;
approved labelling and instructions for use;
device change history;
relevant post-market safety information;
records of significant regulatory actions; and
documentation supporting device sameness.

The South African regulatory structure must also be ready, including the appropriate establishment licence and an appointed Authorised Representative.

Our article on SAHPRA Authorised Representative requirements explains the local representative role in more detail.

Common misconceptions about medical device reliance

The first misconception is that FDA approval automatically means SAHPRA approval. It does not.

The second is that CE marking replaces a South African establishment licence. It does not.

The third is that reliance means no technical dossier is required. Technical documentation remains important.

The fourth is that SAHPRA must accept every conclusion reached by another regulator. SAHPRA retains responsibility for the South African decision.

The fifth is that reliance applies only to product registration. SAHPRA’s framework also covers licensing, ISO 13485 audits, clinical activities and post-market functions.

The sixth is that every foreign approval is equally useful. The issuing authority, scope of assessment, product identity and available supporting evidence all matter.

What reliance means for South African market-entry strategy

For international manufacturers, SAHPRA’s reliance policy should influence market-entry planning well before an application is filed.

The starting point should be a regulatory gap assessment.

The manufacturer should identify what international approvals already exist, what documentation supported those approvals, whether the South African product will be the same device and which evidence may support reliance.

The company should then assess the local requirements separately, including classification, establishment licensing, Authorised Representative arrangements, QMS requirements, product listing, labelling, importation and post-market responsibilities.

This produces a more efficient regulatory strategy than treating the South African submission as an entirely new dossier or assuming that a foreign certificate alone will be sufficient.

Verion Medical’s regulatory affairs services and medical device market-entry guidance support this integrated approach.

Key regulatory references

SAHPGL-MD-22, Medical Devices Reliance Guideline, Version 1, 25 February 2026
Medical Devices Registration Feasibility Study Report, 31 March 2026
Medical Device Registration Voluntary Feasibility Study documentation
SAHPGL-MD-06, medical device establishment licensing guidance
SAHPGL-MD-04, Guideline for Classification of Medical Devices and IVDs
applicable medical-device technical dossier guidance
WHO Good Reliance Practices in the Regulation of Medical Products
WHO transitional Listed Authorities framework for medical devices, published 14 July 2026

How Verion Medical supports medical device reliance and regulatory strategy

Verion Medical supports medical device and IVD manufacturers in determining how existing international regulatory evidence can be incorporated into the South African regulatory pathway.

Our medical device regulatory affairs services can support reliance-readiness assessments, review of foreign regulatory approvals, device sameness assessments, regulatory strategy, local classification and preparation for SAHPRA requirements.

Where reliance forms part of a future product-registration strategy, Verion Medical also provides medical device registration support and technical documentation and labelling support.

For companies establishing a local regulatory structure, our services also include SAHPRA establishment licensing, ISO 13485 and Quality Management Systems and import and export support.

For international manufacturers, the objective is not simply to determine whether a foreign approval exists. It is to establish whether the available regulatory evidence can support the appropriate South African pathway while addressing the local requirements that remain SAHPRA’s responsibility.

If your organisation has international medical-device approvals and is assessing how those approvals may support South African market entry, contact Verion Medical to discuss the applicable reliance and regulatory pathway.