Essential Principles for Safety and Performance under SAHPGL-MD-01 in South Africa

1. Key takeaways

Notice 1515 Regulation 8(6) provides that a medical device or IVD submitted for registration must conform with the Essential Principles for Safety and Performance of Medical Devices, which contain requirements covering quality, safety and performance, as determined by SAHPRA and set out in SAHPGL-MD-01, the Essential Principles for Safety and Performance of Medical Devices and IVDs. The Essential Principles are not a checklist that gets submitted; they are a conformity obligation that must be demonstrated item by item, and the burden of proof sits on the manufacturer side. This has several immediate consequences. Every registration dossier must contain evidence addressing each principle, not merely a signed assertion that the device complies. The demonstration is organised in two layers, general principles and design and construction principles, and the risk management method of ISO 14971 runs through the entire system as the shared methodology. Under the reliance pathway, approvals from reference regulatory authorities can serve as indirect evidence for part of the demonstration, but SAHPRA retains the right to request additional information. Finally, because Regulation 8(7) requires the Declaration of Conformity to be made by the authorised representative, the conformity conclusion that the dossier supports is formally adopted by a natural person in South Africa, which makes the quality of the underlying evidence a matter of personal legal exposure as well as corporate compliance.

2. Legal basis

3. Expert insights

Insight 1: The Essential Principles are the substantive standard of South African review and the interface point for the reliance pathway. Regulation 8(6) writes the Essential Principles into the registration application as a statutory requirement. Under the reliance pathway, approvals by reference regulatory authorities can serve as indirect evidence; under the South African assessment pathway, the conformity must be argued item by item on the manufacturer’s own evidence. Understanding this explains why SAHPRA attaches so much weight to FDA and CE evidence, because those approvals in substance substitute for part of the Essential Principles demonstration. It also explains why reliance never waives the whole obligation: the declaration under Regulation 8(7) still has to be made in South Africa, by the authorised representative, on the strength of whatever evidence the dossier contains.

Insight 2: The Essential Principles are structured in two layers, general and design and construction. The South African system follows the internationally common structure: one layer consists of general principles applicable to all devices, such as acceptable risk, performance consistent with intended use, and design conforming to safety principles; the other layer contains specific requirements for design and construction, covering chemical, physical and biological properties, infection and microbial contamination, manufacturing and cleaning, compatibility with the use environment, and related topics. Arguments should be organised layer by layer, so that general claims are supported at the system level and construction claims at the design level, rather than mixing all evidence in one undifferentiated pile that reviewers must sort through themselves.

Insight 3: The risk management method is the methodological thread running through all principles. The Essential Principles system uses the risk management approach of ISO 14971 as its connecting method. This means the risk documentation is not a standalone file but a common body of method evidence supporting multiple principles. Companies should therefore build a three-layer mapping of principle, risk and evidence, in which each Essential Principle is linked to the specific risk analysis sections that underpin it. A risk file that exists but is not traceable to the principles it serves delivers only a fraction of its value in review, and forces reviewers to reconstruct connections that the manufacturer should have documented.

Insight 4: The Declaration of Conformity is the legal landing point of the Essential Principles demonstration. Regulation 8(7) requires the registration application to be accompanied by a Declaration of Conformity made by the authorised representative. By signing the DoC, the AR formally assumes responsibility for conformity with all of the Essential Principles, which explains why South Africa requires the AR to be a natural person, and signals to manufacturers that they must equip the AR with complete supporting documentation. A declaration signed without underlying records is not a formality; it is an unbacked legal assertion by an identified individual.

Insight 5: Essential Principles conformity is continuous, not a one-off exercise. Post-market design changes, process changes and vigilance events can all affect existing conformity conclusions. Practical estimate: incorporate the Essential Principles matrix into the change management process, so that any change with a potential impact on safety or performance automatically triggers a review of the affected principle entries. This keeps the dossier, the DoC and the actual device aligned across the product lifecycle, and prevents the common failure mode in which conformity evidence quietly drifts out of date while the marketed product evolves.

4. Practical recommendations

1. Organise the demonstration in two layers, general principles and design and construction principles, and keep the evidence for each layer in its corresponding sections.
2. Build a three-layer mapping matrix of principle, risk and evidence: every principle must be traceable to specific documents.
3. Under the reliance pathway, clearly annotate which principles are covered by foreign approvals, and which remain demonstrated on local evidence.
4. Prepare complete supporting documentation before the AR signs the DoC: the declaration is not a formality.
5. Bring the Essential Principles matrix into change management: any relevant change triggers a matrix review.
6. Retain the current version of SAHPGL-MD-01 and keep a version ledger, recording which version the demonstration was built against.

5. Verification checklist

• □ The current version of SAHPGL-MD-01 has been obtained and its version recorded
• □ It has been confirmed under Regulation 8(6) that the Essential Principles are a statutory requirement
• □ The demonstration has been organised in the two layers of general and design and construction principles
• □ A three-layer mapping matrix of principle, risk and evidence has been established
• □ Under the reliance pathway, the principle entries covered by foreign approvals have been annotated
• □ Complete supporting documentation has been prepared for the AR to sign the DoC (Regulation 8(7))
• □ The Essential Principles matrix has been included among change management triggers
• □ It has been clarified which principles are jointly supported by the ISO 14971 risk documentation

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.