Collaborative Medicines Registration Initiative in Southern Africa (ZAZIBONA/SAHPRA) – Med.Device & IVD
Simplified Roadmap
QMS-SR-ZAZIBONA-SAHPRA-Med.Dev.&IVD
Version: 07/20/2025
Prepared by: Dr. Vlad Reznikov
Date: July 20, 2025
Executive Summary
This blueprint outlines the unified regulatory workflow for medical devices and in‑vitro diagnostics (IVDs) marketed in the ZAZIBONA. All member states recognise approvals granted under the union framework, although local import permits may still apply.
Scope & Members
Botswana, Namibia, South Africa, Zimbabwe, Zambia
Lead regulatory authority: ZAZIBONA work‑sharing / SAHPRA lead
Key Regulations & Guidance
Medical Devices: Country MD/IVD regulations (SAHPRA MD/IVD), mutual review reports
IVDs: SAHPRA MDIVD guidance
Estimated Timeline
Total project duration varies by class. Refer to the chart.
Risk Classification
Classes A, B, C, D (IMDRF)
Phases & Timelines
Phase 0 – Classification & Strategy (4 wks)
- Determine risk class and select regulatory pathway (notification vs registration).
- Verify language, labeling, and UDI/GTIN requirements.
Phase 1 – QMS Alignment & Technical Documentation (8–12 wks)
- Implement ISO 13485‑equivalent QMS; compile technical file per union format.
- Include risk management (ISO 14971) and clinical evidence (when required).
Phase 2 – Pre‑Submission / Dossier Validation (4–6 wks)
- Optional advice meeting with lead authority or reference country.
- Administrative completeness and fee payment.
Phase 3 – Submission & Review (12–24 wks)
- Submit electronic dossier via union portal or national hub.
- Respond to queries; provide additional data or samples.
Phase 4 – Certification / Listing & Import License (4 wks)
- Receive registration certificate or listing number.
- Apply for import permits and customs tariff codes.
Phase 5 – Post‑Market Obligations (ongoing)
- Vigilance reporting, periodic safety update, annual retention fees.
- Prepare for GMP/QMS audits by appointed bodies.