Technical Dossier Requirements under SAHPGL-MD-09 and SAHPGL-MD-10 in South Africa

1. Key takeaways

South Africa structures its medical device technical documentation around a dual-guide framework split by product attribute: SAHPGL-MD-09 governs the technical documentation for IVDs, while SAHPGL-MD-10 governs the technical documentation for non-IVD devices, and a separate Assembly and technical guide for technical dossier content uniformly prescribes how the dossier is organised. These documents were designated as the mandatory versions for participants in the May 2024 registration voluntary feasibility study and in Phase 2 of 2026. Note carefully: full product registration in South Africa has not yet been launched, and these two guide sets are currently used mainly in feasibility study and future registration preparation scenarios. For manufacturers, three practical conclusions follow. First, the dossier you compile today must be built on the current versions of the two guides, because a dossier structured against a superseded version will need re-mapping once SAHPRA formally calls for submissions. Second, the assembly guide means that the table of contents and the physical organisation of files are themselves review objects, not packaging preferences. Third, the technical dossier is the evidentiary vehicle for the Essential Principles required by Regulation 8(6), so every claim of conformity should be traceable to a specific document within the dossier rather than left for reviewers to reconstruct. Compilation takes significant time, while the call for registration may allow only a short transition period, so the strongest strategy in the current window is to build the dossier now, on the designated versions, with a documented version ledger.

2. Legal basis

3. Expert insights

Insight 1: The dual-guide structure reflects the difference in evidence types between IVDs and non-IVDs. For IVDs, the core evidence is analytical and clinical performance, covering limit of detection, precision, interference, stability, clinical concordance and clinical performance studies; for non-IVD devices, the core evidence is mechanical, electrical and biocompatibility characteristics together with clinical safety and effectiveness. The two streams cannot share a single template, and this is precisely where companies most often go wrong when they prepare one dossier intended to serve multiple markets. A manufacturer that adapts a CE technical file by pasting IVD performance data into a non-IVD structure, or the reverse, will find that SAHPRA reviewers cannot locate the evidence they expect in the sections where the relevant guide places it.

Insight 2: The dossier assembly guide is a science of the table of contents, not an optional extra. The fact that SAHPRA issues the Assembly and technical guide for technical dossier content separately from the two content guides tells you that the directory structure and the organisation of files are themselves subject to review. A dossier whose content is complete but whose table of contents is disorganised will measurably increase review time, because reviewers must hunt for evidence that should have been indexed for them. The recommended approach is to map every item against the official table of contents and to provide a cross-reference index at the front of the dossier, so that each requirement points to a named section, file and page.

Insight 3: The technical dossier is the core asset for future registration and can be completed before the call. Because product registration has not yet been called for, companies can already compile their technical documentation in accordance with SAHPGL-MD-09 and SAHPGL-MD-10, both as the basis for participating in the feasibility study and as preparation for future registration. This is the most worthwhile investment available in the current window: dossier compilation has a long cycle, while the call for registration announcements may give applicants only a very short transition period in which to respond. Manufacturers who wait for the call will be compressing years of evidentiary work into weeks.

Insight 4: The feasibility study designates the guide versions that must be used. Phase 2 of 2026 explicitly requires participants to use the versions of the guides and templates published together with the call for expressions of interest, rather than the legacy versions used in Phase 1. This tells you two things at once: the guides are still iterating quickly, and version management is itself part of dossier compliance. A company that tracks which version of each guide and template it used, when it was downloaded, and what changed between versions will be able to respond to a version change without rebuilding its index from scratch.

Insight 5: The technical dossier and the Essential Principles stand in an evidence-to-conclusion relationship. Regulation 8(6) requires that devices conform with the Essential Principles for safety and performance; the technical dossier is the evidentiary vehicle that proves that conformity. Companies should build an evidence index principle by principle, so that each Essential Principle maps to specific test reports, risk files and clinical documents, instead of stacking documents into the dossier and expecting reviewers to assemble the picture themselves. This mapping also serves the Declaration of Conformity required by Regulation 8(7), which is signed on the strength of the dossier.

4. Practical recommendations

1. Determine whether the product is an IVD or a non-IVD before selecting the guide: the two systems cannot be mixed, and the choice drives every downstream template.
2. Organise the dossier table of contents per the official assembly guide, and provide an item-by-item cross-reference index at the front of the submission.
3. Build an evidence matrix keyed to the Essential Principles: each principle should correspond to named evidence files within the dossier.
4. Start dossier compilation now: completing it before the registration call is the optimal strategy for the current window.
5. Maintain a guide version ledger: SAHPGL-MD-09 and SAHPGL-MD-10 are still iterating, and version changes should be logged.
6. Feasibility study participants must use the designated versions published with the call for expressions of interest, not legacy Phase 1 templates.

5. Verification checklist

• □ It has been determined whether the product falls under the IVD guide (MD-09) or the non-IVD guide (MD-10)
• □ The current versions of both guide sets have been obtained
• □ The dossier table of contents has been organised per the assembly guide with a cross-reference index attached
• □ An evidence matrix keyed to the Essential Principles, principle by principle, has been established
• □ The dossier version and the guide versions have been recorded in the version ledger
• □ Feasibility study participants have confirmed use of the designated versions
• □ The language and format of the technical documentation meet submission requirements (English)
• □ An annual dossier update mechanism has been planned

Regulatory information verified as of 29 October 2026. The regulations, guidance documents and effective dates described in this article are limited to the official sources listed under Legal basis 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 dossier preparation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence applications and renewals, reliance pathway justification, technical dossier and Essential Principles conformity argumentation, labelling and IFU localisation in English, and support for post-market vigilance and annual compliance information submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.