Cuba medical device registration timeline
Source-linked clocksState Center for the Control of Medicines and Medical Devices (CECMED) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — Regulación E 117-23 risk-classification rules classification system.
2 pathways2 of 2 clocks verifiedvalidity 5 years maximum — Resolución Ministerial 184/2008 Art. 59, renewable for a further five years, and the CECMED may fix a shorter period in a reasoned caseMDSAP not acceptedreviewed 2026-08-30gacetaoficial.gob.cu
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| All classes — sanitary registration (registro sanitario)(CECMED state evaluation, then certificate issued by the direction on the Certification Commission result) Art. 57: conformity assessment ends with a technical report put before the Certification Commission within 90 working days; Art. 52 puts the documentary-review notification at 10 working days from receipt | 90 working days | 6-12 months | — | Verified |
| All classes — renewal (prórroga del registro)(CECMED re-evaluation before the five-year certificate expires) Art. 57 gives the renewal technical report 60 working days rather than 90 | 60 working days | 4-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesCuba Medical Device Registration Process
Step-by-step CECMED registration process. Total estimated timeline: 6-12 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by CECMED. Appoint a Suministrador inscribed with CECMED (need not be resident in Cuba).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to CECMED including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksCECMED reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
90 working daysIn-depth technical assessment of device safety and performance. CECMED may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, CECMED issues Cuba market authorization certificate.
Summary: The Cuba medical device registration process through State Center for the Control of Medicines and Medical Devices (CECMED) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
CE Mark (EU MDR)Registration in a country with an essential-principles programme opens proceder B and waives some test reports
FDA 510(k)/PMASame route: recognised origin-country registration evidence rather than a separate reliance pathway
Key requirements
- Only inscribed manufacturers may apply: Art. 41 bars a registration application from anyone not yet inscribed, and E 86-16 will not start the evaluation until the inscription has finished
- Inscription clocks (E 129-25): 130 natural days for the CECMED decision, one request for further documentation with 120 natural days to answer, a regulatory audit held within 180 natural days of the paid request and decided within 30 natural days of the approved report, and reinscription filed in the 45 natural days before expiry
- Importers get a separate constancia de inscripción within 10 working days of the application, valid two years (Art. 97)
- Clinical investigation authorisation: 60 working days from receipt of the information (Art. 63)
- A prior registration certificate from the country of origin, or from a country whose device programme rests on the same essential principles, waives part of the test-report package
- Appeal against a CECMED measure lies to the BRPS within 20 working days, and its decision is final (Art. 113)
- A refused device cannot be re-filed for six months (E 86-16 §4.2.3)
Primary regulator sources
gacetaoficial.gob.cu · Resolución Ministerial No. 184/2008, Reglamento para la Evaluación y el Control Estatal de Equipos Médicos (Gaceta Oficial Ordinaria No. 64 de 22/12/2008) — Art. 52 ten-working-day documentary review, Art. 56 thirty-working-day applicant response, Art. 57 ninety/sixty-working-day technical report, Art. 59 five-year certificate, Art. 63 clinical investigation, Art. 97 importer inscription, Art. 113 appeal cecmed.cu · CECMED Regulación E 86-16, Evaluación Estatal de Equipos y Dispositivos Médicos (in force 29/07/2016) — procederes A to D by risk class, §4.2 outcomes, §4.3 registration validity cecmed.cu · CECMED Regulación E 129-25, inscripción de fabricantes, suministradores e importadores de dispositivos médicos (Resolución No. 43) — §3.8 audit scheduling, §6.1 130-natural-day inscription decision, §6.2 120-natural-day applicant window
Reviewed 2026-08-30. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against CECMED publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:cuba:registro-sanitario