SAHPRA Reliance Pathway under SAHPGL-MD-22: Reference Authorities and Scope

1. Key takeaways

On 25 February 2026, SAHPRA published the Medical Devices Reliance Guideline (document number SAHPGL-MD-22, version 1), establishing the principles and procedures for regulatory reliance. The guideline applies to pre-market and post-market regulatory activities, including establishment licensing, product registration, clinical trial approval, ISO 13485 audits, post-market and market surveillance, as well as imports for donation, exhibition and evaluation purposes. The recognised reference regulatory authorities are: the US FDA, the European Union, Australia’s TGA, Japan’s PMDA/MHLW, Canada’s Health Canada, and Brazil’s ANVISA; for IVDs, WHO Prequalification (PQ) is additionally included.

The essential message of the guideline is that reliance reduces duplicated review work but never removes the filing obligation: SAHPRA expressly retains the right to request additional information. For companies holding approvals from reference authorities, the guideline converts those approvals into a procedural asset; for companies without them, the separate South African assessment pathway remains the route, and the evidence interface in Regulation 8 becomes decisive.

2. Legal basis

The table below lists the official sources relied upon.

3. Expert insights

Insight 1: Reliance is not automatic recognition; it is qualified acceptance with the right to ask questions retained. SAHPGL-MD-22 makes clear that SAHPRA reserves the right to request additional information based on the knowledge available at the time of assessment in order to confirm the safety, quality and performance of a device. Holding an FDA or CE approval therefore does not mean exemption from review — the value of reliance lies in reducing duplicated assessment workload, not in waiving the application obligation. Companies should present reference approvals as supporting evidence within a complete file, not as a substitute for one, and should expect targeted questions on any element the reference authority did not itself evaluate.

Insight 2: Reliance spans the full lifecycle, not only registration. The activities listed in the guideline include establishment licensing, product registration, clinical trial approval, ISO 13485 audits, post-market and market surveillance, and imports for donation, exhibition and evaluation purposes. This is the most underestimated aspect of the reliance mechanism: because it extends to post-market activities, foreign inspection reports and vigilance conclusions may also be accepted by SAHPRA. A foreign authority’s adverse finding can therefore travel into the South African record, which raises the stakes of post-market compliance in reference jurisdictions.

Insight 3: Regulation 8 long ago reserved the documentary interface for reliance. Item 8(5)(b)(iii) requires the application form to state the device’s classification and registration status with recognised authorities outside South Africa; item 8(9) provides that where a device is already registered abroad, the application must be accompanied by certified copies of the registration certificate or pre-market approval, the instructions for use, the conditions of registration, and any other information SAHPRA requires. These two provisions are precisely the documentary foundation of the reliance pathway — the 2026 guideline proceduralises what the existing provisions already anticipated.

Insight 4: WHO Prequalification is a separate seventh channel for IVDs. The guideline lists WHO PQ separately for IVDs. For Chinese IVD companies focused on infectious disease testing for HIV, TB, malaria and similar targets, WHO PQ may be a more realistic route than CE marking — and this channel carries radiating value across most African markets, making it worth early evaluation. Companies should weigh the PQ timeline and scope against the specific product categories and decide whether PQ evidence or a reference authority approval will anchor the reliance file.

Insight 5: Reliance is connected to regional collaboration. The guideline also touches on ZAZIBONA, the collaborative review procedure among member states of the Southern African Development Community. This means South African reliance decisions have a regional spillover effect — companies using South Africa as their base can expect the collaborative mechanisms to extend coverage across the wider southern African region. Positioning the South African file with ZAZIBONA-compatible documentation multiplies the return on the same preparation effort.

4. Practical recommendations

The following actions convert the guideline into a workable filing strategy.

1. Inventory the reference authority approvals already held: list FDA, CE, TGA, PMDA, Health Canada, ANVISA and WHO PQ approvals item by item.
2. IVD companies should evaluate WHO PQ first: it is especially suitable for infectious disease testing categories.
3. Prepare the four items required by Regulation 8(9): certified copies of registration certificates, instructions for use, conditions of registration, and other information.
4. Do not slim the dossier because of reliance: SAHPRA retains the right to ask questions, so the file must remain complete.
5. Bring foreign inspections and vigilance conclusions into the evidence package: reliance extends to post-market activities.
6. Assess South Africa as a regional node: combine the filing with ZAZIBONA for a southern African footprint.

5. Verification checklist

Confirm every item below before assembling the reliance file.

• □ The current text of SAHPGL-MD-22 v1 (2026-02-25) has been obtained
• □ The reference regulatory authority approvals available for the product have been inventoried
• □ The four categories of foreign registration materials required by Regulation 8(9) have been prepared
• □ The foreign classification and registration status has been completed per Regulation 8(5)(b)(iii)
• □ It has been confirmed that reliance does not waive the complete dossier obligation
• □ Foreign inspection and vigilance conclusions have been compiled as supplementary evidence
• □ The applicability of WHO Prequalification has been evaluated for IVD products
• □ The feasibility of South Africa as a southern African regional node has been assessed

Regulatory information verified as of 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the official sources listed in the legal basis section above, as published on that date. Where official documents are subsequently updated, the latest published version prevails.

• South Africa local resources: GRZAN assists manufacturers from the Chinese mainland and overseas with SAHPRA medical device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) scheme design, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification determination, technical documentation preparation, and the establishment of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence application and renewal, reliance pathway justification, technical documentation and Essential Principles conformity argumentation, labelling and instructions-for-use localisation (English), and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.