Regional Harmonisation through ZAZIBONA and the WHO CRP

1. Key takeaways

South Africa participates in regional harmonisation along two tracks: first, ZAZIBONA, the collaborative registration procedure among member states of the Southern African Development Community (SADC), which has been written into the SAHPRA guidance on reliance for medical devices (SAHPGL-MD-22 v1, dated 25 February 2026); and second, the WHO Collaborative Registration Procedure (CRP), for which the SAHPRA medical device division has expressed its intention to participate, covering IVD new product registrations and post-registration changes. For companies targeting Africa, the value of South Africa lies not only in its domestic market but in its position as a regional reference point and harmonisation hub. A regulatory approval pathway that can be leveraged across several southern African markets changes the economics of market entry, and companies that plan for this early will build evidence packages once and reuse them many times over.

2. Legal basis

3. Expert insights

Insight one: writing ZAZIBONA into SAHPGL-MD-22 is substantive progress in regional harmonisation. The reliance guidance does not only list reference regulatory authorities; it also covers ZAZIBONA, the collaborative procedure of SADC member states. Its significance is that a single review conclusion can, in principle, be recognised across several southern African markets, upgrading South Africa from a single market to a regional gateway. For portfolio planning, this means that the marginal cost of each additional southern African market decreases once the first collaborative review is completed.

Insight two: the WHO CRP delivers the highest value for IVD companies. SAHPRA has expressed its willingness to participate in the WHO Collaborative Registration Procedure for IVD new product registrations and post-registration changes. For diagnostic products for HIV, TB, malaria and hepatitis, the WHO CRP and WHO prequalification (PQ) form a combined advantage — PQ supplies the evidentiary basis, and the CRP supplies the acceleration of registration. Companies in this space should therefore sequence their regulatory work so that PQ and CRP submissions reinforce each other rather than run as disconnected projects.

Insight three: regional harmonisation and reliance pathways support each other. SAHPGL-MD-22 recognises WHO prequalification as a reliance basis for IVDs, while SAHPRA participates in the WHO CRP. Both lines point to the same conclusion: IVD companies should treat WHO PQ as one of the priority qualifications to obtain, because its marginal value across southern Africa is far higher than its value in any single market.

Insight four: regional harmonisation does not change South Africa’s domestic mandatory requirements. Even where recognition is obtained at regional level through ZAZIBONA or the CRP, domestic South African obligations such as the establishment licence, ISO 13485, vigilance and annual submissions continue to exist independently. Regional harmonisation improves the efficiency of product review; it does not cover entity-level compliance. Budgets and project plans must therefore carry both tracks in parallel.

Insight five: the timing of regional harmonisation is linked to the call-up announcement. Since South Africa has not yet issued a call-up notice for product registration, the practical effect of ZAZIBONA and the CRP currently shows mainly on the existing channels for medicines and IVDs. The practical estimate is that device companies should treat regional harmonisation as a medium- to long-term layout while advancing domestic South African compliance on the domestic timetable.

4. Practical recommendations

1. IVD companies should first assess WHO prequalification and the WHO CRP: the combined value is highest.
2. Position South Africa as a regional hub rather than a single market: plan for the long term.
3. Watch the conditions for applying ZAZIBONA in SAHPGL-MD-22: confirm case by case.
4. Regional recognition does not replace domestic South African obligations: licensing and vigilance remain independent.
5. Plan the evidence package against a list of target countries: move from one dossier per country to a shared regional package.
6. Track the progress of SADC and the African Medicines Agency (AMA): they will shape the long-term landscape.

5. Verification checklist

• □ The statements on ZAZIBONA in SAHPGL-MD-22 v1 have been obtained
• □ The applicability of WHO prequalification to the company’s IVD products has been assessed
• □ It is understood that the WHO CRP covers IVD new registrations and post-registration changes
• □ Positioning South Africa as a regional hub is part of the long-term plan
• □ It has been confirmed that regional recognition does not replace South African establishment licence and ISO 13485 obligations
• □ The evidence package has been restructured for regional reuse (not one dossier per country)
• □ SADC and AMA developments are on the monitoring list
• □ The conditions for applying regional harmonisation are confirmed with SAHPRA case by case (a practical estimate)

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 have been updated, the most recently published version prevails.

• Local resources in South Africa: GRZAN assists manufacturers from the Chinese mainland and other markets 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, and the setup of vigilance and adverse event notification mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway argumentation, technical documentation and essential principles conformity argumentation, labelling and instructions for use localisation in English, and support for post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.