Mozambique medical device registration timeline
Source-linked clocksAutoridade Nacional Reguladora de Medicamento (ANARME) review clocks, using the Separate MD/IVD A–D axes; registration also depends on priority-list membership classification system. End-to-end planning estimates are unavailable.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Device/IVD notification Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 30 days | — | — | Verified |
| Normal AIM Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 120 days | — | — | Verified |
| Recognition or collaborative AIM Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 90 days | — | — | Verified |
| Alteration Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 90 days | — | — | Verified |
| AIM renewal Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 90 days | — | — | Verified |
| AIM ownership transfer Manual section 8.2, physical PDF page 28. Applies to properly instructed dossiers; requests for information suspend the clock. The original table says days without specifying calendar versus working days. These procedure clocks are not risk-class bands or end-to-end project estimates. | 30 days | — | — | Verified |
Review clocks exclude applicant hold time · end-to-end planning estimates unavailable- Use notification for Class A and non-priority B-D products; use registration for priority B-D products.
- Recognized and WHO collaborative routes require their own qualifying authorization and dossier evidence.
- Renewal is filed 90 days before expiry.
Reviewed 2026-10-28. End-to-end planning estimates are unavailable.