Market Authorisation History Declaration and Foreign Registration Evidence in South Africa

1. Key takeaways

Notice 1515 Regulation 8(9) provides that where a device submitted for registration has already been registered with a regulatory authority outside South Africa, the application must be accompanied by the following information: (a) a certified copy of the registration certificate or pre-market authorisation (where applicable); (b) the instructions for use (where applicable); (c) the conditions of registration; and (d) any other information determined by SAHPRA. SAHPRA has also issued a Market Authorisation History Declaration template for applicants to complete. These four categories of material are the evidentiary core of the reliance pathway, and their completeness directly determines whether SAHPRA can accept the foreign conclusions. In practice, the first two items, the certified certificate copy and the instructions for use, are usually straightforward to obtain, while the conditions of registration are often the hardest, because many jurisdictions do not publish them as a single document and they may be scattered across approval letters, annexes and subsequent correspondence. The certification requirement also raises procedural questions about notarisation and legalisation chains that should be resolved before documents are commissioned. Finally, the word History in the template name signals that the declaration must cover the device’s authorisation record across markets, including refusals, withdrawals and restrictions, since SAHPRA makes clear that the regulatory conditions attached to the foreign approval declared to it must continue to be met.

2. Legal basis

3. Expert insights

Insight 1: Regulation 8(9) is a reliance interface written into the rules back in 2016. The provision required certified copies of foreign registration certificates and the conditions of registration a full ten years before the reliance guidance was issued. This shows that reliance is not an invention of 2026 but the institutionalisation of an existing provision, and companies preparing foreign approval documents should align directly against these four items. The practical benefit is predictability: because the statutory list is fixed, the evidence-gathering plan can be built item by item, with an owner and a date for each, long before the South African submission is drafted.

Insight 2: The conditions of registration are often the hardest item to obtain. The first two items, the certified copy of the certificate and the instructions for use, are usually easy to acquire, but the conditions of registration are in many jurisdictions not public documents, or are scattered across approval letters, annexes and subsequent correspondence. Practical estimate: request the complete approval letter and conditions list from the foreign licence holder early, and reserve time for notarisation and legalisation. Where the foreign authority communicates conditions by incremental letters, assemble them into a single indexed set, because a reviewer who receives an unordered bundle must reconstruct the condition history unaided.

Insight 3: The certified copy requirement involves a notarisation and legalisation chain. The provision requires a certified copy. Practical estimate: the specific form, whether notarisation, consular legalisation or an apostille, depends on the country of origin of the document and SAHPRA’s case-specific requirements, and should be confirmed at the preparation stage to avoid producing unusable documents. Because certification chains can take weeks in some jurisdictions, and re-certification is needed if the underlying certificate is reissued, the form should be fixed before the document leaves the issuing authority rather than discovered after it arrives in South Africa.

Insight 4: The market authorisation history declaration must cover all markets, not only the most favourable one. The word History in the template name indicates coverage of the device’s authorisation history across markets. Where a product has been refused, withdrawn or restricted in any market, that information is part of the history. The risk of concealing an unfavourable history is far higher than disclosing it truthfully. SAHPRA can verify foreign status through its own channels, and an undisclosed refusal discovered later converts a manageable disclosure into a credibility problem that colours the whole application.

Insight 5: Changes to foreign conditions continue to affect South African compliance. SAHPRA makes clear that the regulatory conditions attached to the foreign market approval declared to SAHPRA must continue to be met. This means that once a foreign registration is suspended, withdrawn or amended, the compliance basis on the South African side is correspondingly shaken, and companies should establish a mechanism for monitoring foreign registration status. The monitoring should have a defined owner, defined sources and a defined escalation step, so that a foreign status change triggers a South African-side assessment within a bounded time rather than surfacing at renewal or inspection.

4. Practical recommendations

1. Gather evidence aligned to the four items of Regulation 8(9): certified copy, instructions for use, conditions of registration, other information.
2. Request the complete approval letter and conditions list early: this is the hardest item to obtain.
3. Confirm the specific form of certification: notarisation, legalisation or apostille.
4. Declare the market authorisation history truthfully across all markets: including unfavourable history.
5. Establish a monitoring mechanism for foreign registration status: changes trigger a South African-side assessment.
6. Reserve the evidence-gathering and certification period in the project schedule: foreign evidence gathering is often the bottleneck of the dossier.

5. Verification checklist

• □ A certified copy of the foreign registration certificate or pre-market authorisation has been obtained (Regulation 8(9)(a))
• □ The foreign instructions for use have been obtained (Regulation 8(9)(b))
• □ Complete documentation of the conditions of registration has been obtained (Regulation 8(9)(c))
• □ The specific form of certification for the certified copy has been confirmed and completed
• □ The market authorisation history declaration truthfully covers the authorisation history across all markets
• □ A monitoring mechanism for changes in foreign registration status has been established
• □ The commitment to continued satisfaction of foreign conditions has been brought into internal management
• □ The evidence-gathering and certification period has been reserved in the project schedule

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.