Nicaragua medical device registration timeline
Source-linked clocksNational Authority for Health Regulation (ANRS/MINSA) review clocks, using the Local MD I–IV and separate IVD I–III rules; clocks depend on procedure classification system. End-to-end planning estimates are unavailable.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| New registration evaluation NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse. Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted. | 60 working days | — | — | Verified |
| Renewal evaluation NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse. Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted. | 40 working days | — | — | Verified |
| Post-registration change evaluation NTON 24001:2023 Annex A, other considerations item 4, physical PDF page 32. Clock begins after pre-evaluation is approved and ends with the evaluation result, which may be adverse. Corrections and responses have separate rules; no unconditional end-to-end approval or project-total estimate is asserted. | 20 working days | — | — | Verified |
Review clocks exclude applicant hold time · end-to-end planning estimates unavailable- Complete ANRS pre-evaluation before these evaluation-result clocks begin.
- For further evaluation after correction, Annex A item 5 specifies 15 working days, subject to chapter 7 rejection and cancellation limits.
- Five-year registration; renew between nine and six months before expiry.
Reviewed 2026-10-28. End-to-end planning estimates are unavailable.