Declaration of Conformity under Regulation 8(7) in South Africa

1. Key takeaways

Notice 1515 Regulation 8(7) provides that the registration application for a medical device or IVD must be accompanied by a Declaration of Conformity (DoC) made by the authorised representative (AR), in a form determined by SAHPRA. For the registration feasibility study SAHPRA published two DoC templates, a Manufacturer DoC and a Distributor DoC (Manufacturer/Distributor DoC template), together with a Declaration of Conformity guidance explaining how the DoC corresponds to the Essential Principles. The DoC is signed by the AR rather than by the company, which is the key difference between the South African system and most other markets. The practical consequences are significant. Because the AR named in Notice 1515 is a natural person resident in South Africa, the signature on the DoC belongs to an identifiable individual who, by definition, is responsible for the performance, quality and safety of the device and for compliance with registration conditions. Choosing the wrong template creates a mismatch between the content of the declaration and the actual role of the declarant, and constitutes a deficiency in review. The DoC also serves as the common endpoint of both the reliance pathway and the local assessment pathway, so its content should point to conformity with the Essential Principles item by item, backed by the dossier, rather than to a management system certificate.

2. Legal basis

3. Expert insights

Insight 1: The signatory of the DoC is a natural person AR, not a legal entity. The wording of Regulation 8(7) is a Declaration of Conformity made by the authorised representative, and the AR defined in Notice 1515 is a natural person resident in South Africa. This means the DoC carries the name of a specific individual, who under the definition must answer for the performance, quality and safety of the device and for compliance with registration conditions. Companies must, in their internal management, provide the AR with sufficient supporting documentation; otherwise the legal risk of the signature is borne entirely by the individual. In practice this means assembling a signed-evidence package for the AR before signing, covering the technical dossier, conformity assessment records and any foreign approvals relied upon.

Insight 2: The two templates correspond to two different sources of responsibility. The Manufacturer DoC declares conformity of the design and manufacturing process with the Essential Principles; the Distributor DoC declares conformity of the products distributed and the inheritance of the original manufacturer’s evidence. Selecting the wrong template produces a declaration whose content does not match the actual capability of the declarant, which constitutes a deficiency directly in review. Companies should therefore classify their South African role first, manufacturer, distributor or both, and hold both templates on file if they operate in more than one capacity, so that each application uses the form that matches the declared role.

Insight 3: The object of the DoC is the Essential Principles, not a particular standard. Regulation 8(6) and 8(7) form a closed loop: (6) requires conformity with the Essential Principles, and (7) requires a declaration to that effect. The content of the DoC should therefore point to conformity with the Essential Principles item by item, rather than stating generically that the device conforms with ISO 13485. A quality management system certificate and a product conformity declaration are two different things. Conflating them is a recurring error: the certificate attests to the management system, while the DoC attests to the device, and reviewers treat references to the wrong object as evidence that the declarant has not understood the obligation.

Insight 4: The DoC is the common endpoint of the reliance pathway and the local assessment pathway. Whichever pathway an application takes, it ultimately lands on this declaration signed by the AR. The difference lies only in the source of the supporting evidence: under the reliance pathway, approvals of reference regulatory authorities may be cited; under the local assessment pathway, conformity assessment and self-declaration evidence must be cited. Companies should treat the DoC as the master table of contents of the evidence chain, not as a signature on the last page. Read this way, preparing the DoC becomes a planning exercise that tells you, in advance, which evidence files must exist before signing.

Insight 5: The DoC must be updated in step with the product and the evidence. Design changes, process changes and changes to foreign registration conditions can all render an existing DoC stale. Practical estimate: include the DoC in the change management list, so that a significant change triggers re-signing and archiving of the new version with its signing date. This keeps the signed declaration aligned with the device actually placed on the market and preserves an auditable trail of which version was in force at any given time.

4. Practical recommendations

1. Confirm that the signatory is a natural-person AR resident in South Africa: do not substitute a company seal for the personal signature.
2. Select the template according to the actual role of the declarant: manufacturer or distributor, without mixing the two.
3. Point the DoC content to conformity with the Essential Principles item by item: do not cite the management system standard generically.
4. Prepare complete supporting documentation for the AR: technical dossier, conformity assessment records, foreign approvals.
5. Bring the DoC into change management: significant changes require re-signing.
6. Keep records of DoC versions and signing dates for inspection and renewal verification.

5. Verification checklist

• □ It has been confirmed that the DoC must be signed by a natural-person AR in South Africa (Regulation 8(7))
• □ The correct template has been selected according to the role of the declarant (manufacturer or distributor)
• □ The DoC content points to conformity with the Essential Principles of SAHPGL-MD-01 item by item
• □ Complete supporting documentation has been prepared for the AR
• □ The distinction between the management system certificate and the product conformity declaration has been made
• □ The DoC has been brought into change management, with significant changes triggering re-signing
• □ DoC versions and signing dates have been recorded and archived
• □ The current SAHPRA DoC templates and guidance have been obtained

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.