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CECMED · structured requirements

🇨🇺 Cuba medical device regulatory data

Explore the medical device requirements currently available for Cuba, organized by topic and linked to official sources.

42 facts23 dimensions16 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Promotion/advertising control and reporting form

promotion.control
Fact-level verified

CECMED establishes control of the promotion, marketing and advertising of medical devices to avoid communication of false or misleading information (E 132-25, epígrafe 3.53). CECMED additionally publishes a (pilot) reporting form for suspected falsified and illicit devices and for inappropriate promotion or advertising, enabling third-party reporting.

Conditions
  • Applies to device promotion, marketing and advertising in Cuba.

E 132-25 epígrafe 3.53: 'El CECMED establece el control de la promoción, la comercialización y la publicidad de dispositivos médicos para evitar la comunicación de información falsa o engañosa.'

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Renewal adds 5 years; total registration+renewal capped at 10 years

validity.prorroga-10-year-cap
Fact-level verified

Per Article 59 of the Reglamento, the registration of a device may be extended (prórroga) for a five-year period from the expiry date of the first registration; the total validity of registration plus prórroga may not exceed ten years, after which a new registration application must be filed. E 84-16 (Resolución CECMED 48/2016, in force 27/07/2016) governs the renewal/modification process; during prórroga the manufacturer must demonstrate continued compliance with the essential requirements and effectiveness in use during the approved validity period.

Conditions
  • Applies to national and imported devices continuing in the SNS without significant design/manufacturing variations.

Effective from 2016-07-27

PDF text is OCR-extracted; excerpt spacing reflects the extraction.

Renewal application window: 90 days before expiry

validity.prorroga-90-day-window
Fact-level verified

The prórroga of the Registro Sanitario must be requested by the manufacturer or its representing suministrador during the 90 days before the registration expiry date. If not filed, cancellation takes effect from the expiry date.

Conditions
  • Window applies to device registrations; operator reinscription instead uses a 45-day window under E 129-25.

Effective from 2016-07-27

PDF text is OCR-extracted; excerpt spacing reflects the extraction.

Registration valid up to 5 years; cancelled if no renewal request

validity.registration-5-years
Fact-level verified

The Registro Sanitario is valid for the period stated in the Registration Certificate, not exceeding five years. At the manufacturer's request the registration may be extended (prórroga) for periods not exceeding five years, subject to new evaluation under the renewal regulation (E 84-16). If by the expiry date the manufacturer has not filed the prórroga application, CECMED proceeds to cancel the registration.

Conditions
  • Applies to all device registrations under E 86-16.

Effective from 2016-07-29

Denial of registration bars a new application for the same device for 6 months (acápite 4.2.3).

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Base regulation (Reglamento, RM 184/2008)

authority.base-reglamento-184-2008
Fact-level verified

The binding base regime is the Reglamento para la Evaluación y el Control Estatal de Equipos Médicos, approved by MINSAP Resolución No. 184 of 2008, published in Gaceta Oficial No. 64 Ordinaria de 2008 (norm identifier GOC-2008-1472-O64). It derogated Resolución 110 de 1992 and Resolución 165 de 1997 of MINSAP.

Conditions
  • Applies to all equipos médicos; complemented by CECMED regulaciones (E-series).

Official sources conflict on the approval date: Boletín AR 00-365 (2020) states 'Resolución No. 184 de fecha 22 de diciembre de 2008'; Resolución 28/2023 (E 117-23) and Res. 43/2025 (E 129-25) state '22 de septiembre del año 2008'. The Gaceta record lists only year 2008.

Competent authority

authority.competent-authority
Fact-level verified

CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos) is the national regulatory authority for medical devices/equipment and IVDs (diagnosticadores). It was created by MINSAP Resolución No. 153 of 27 June 2011 (fusion of BRPS, CECM and CCEEM under Ministerio de Economía y Planificación Resolución 263/2011) and operates under the mission and functions approved by MINSAP Resolución No. 165 of 14 April 2014, subordinate to the Ministry of Public Health.

Conditions
  • Applies to all device classes and to IVDs.

Identical recitals appear in Regulación E 129-25 (Res. 43/2025) and Boletín Ámbito Regulador 00-365 (2020).

New public-health framework (Decreto 133/2025)

authority.health-law-decree-133-2025
Fact-level verified

Decreto No. 133/2025 of the Council of Ministers, Reglamento de la Ley 165 'Ley de la Salud Pública', was published in Gaceta Oficial GOC-2026-123-O9 of 23/12/2025, enters into force 90 days after publication, and derogates Decreto 139 of 4 February 1988 (the previous Reglamento of the health law).

Conditions
  • General health-law framework; sector rules (Reglamento RM 184/2008 and CECMED regulaciones) continue to govern devices specifically.

90 days after 23/12/2025 publication computes to 23/03/2026 (as noted in the catalog row); the source states the 90-day rule.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Significant modifications require new registration; others classified by CECMED

change.significant-new-registration
Fact-level verified

Modifications to a device are classified as significant or non-significant: if significant (per Article 11 of the Reglamento, Chapter I), a new registration process - not a prórroga - is required. For renewal and modification the manufacturer must declare the modifications suffered during the registration's validity with evidence they do not affect safety, efficacy and effectiveness; CECMED specialists classify them. E 132-25 epígrafe 3.26 additionally allows CECMED to warn a manufacturer to start reclassification of a device on the market when new evidence changes its risk. Modification of a registered device is a priced trámite (fee rows A54-14 to A60-14).

Conditions
  • Applies to changes arising during the exploitation phase of registered devices.

Effective from 2016-07-27

PDF text is OCR-extracted; excerpt spacing reflects the extraction.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evidence regulation E 79-15 (Res. 138/2015)

clinical.e79-15-evidence-regulation
Fact-level verified

Resolución CECMED No. 138/2015 (approved 31/08/2015, in force 31/10/2015) approved Regulación E 79-15 Edición 3, 'Presentación de evidencias clínicas para el Registro Sanitario de equipos y dispositivos médicos', which governs the clinical evidence presented with registration applications; it derogated Regulación ER-6 (requirements for clinical trials of medical equipment) and Guía GT-4a (protocols and final reports). CECMED grants the authorizations for executing clinical investigations involving devices (E 132-25, epígrafe 3.44).

Conditions
  • Applies to the clinical-evidence component of registration dossiers, notably Class IIb/III.

Effective from 2015-10-31

ER-16 for exceptional-use permits references NC ISO 14155-1 y 2:2005 for clinical investigation of devices in human subjects.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Medical device definition (E 132-25, 2.13)

device-definition.dm
Fact-level verified

Dispositivo médico (DM) is defined as any instrument, apparatus, implement, machine, artifact, implant, in-vitro reagent, software, material or other similar or related article intended by the manufacturer for use in humans for medical purposes such as diagnosis, prevention, control, treatment or alleviation of disease, or investigation, replacement or support of anatomy or a physiological process.

Conditions
  • Definition aligned with the WHO Global Model Regulatory Framework 2023; software is expressly included.

Effective from 2025-07-23

Replaces the older term 'equipo médico' without changing the substantive scope.

IVD definition (DMDIV) and diagnosticador terminology

device-definition.dmdiv-diagnosticador
Fact-level verified

IVD medical devices are 'Dispositivo médico para diagnóstico in vitro (DMDIV)': devices intended by the manufacturer for in-vitro analysis of samples derived from the human body to supply information for diagnosis, monitoring or compatibility. In Cuba they were previously identified as 'diagnosticadores'; in the DMDIV sense the term excludes software, sample containers and laboratory equipment, and covers reagents, calibrators and control materials.

Conditions
  • DMDIV follow the IVD-specific regime (LSOD licences) rather than the equipment/device inscription system.

Effective from 2025-07-23

Nota 2: 'En Cuba se identificaban anteriormente como diagnosticadores. Este término excluye el software, los recipientes para muestras y los equipos de laboratorio.'

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Clinical evaluation report required for Class IIb/III

dossier.clinical-evaluation-iib-iii
Fact-level verified

For Class IIb and III devices, the dossier must include a clinical evaluation report prepared from clinical data collected by the manufacturer to demonstrate safety and efficacy of the device for the requested application and medical specialty, per the regulation on presentation of clinical evidence for registration (Regulación E 79-15). Class IIb, III and novel devices require clinical evidence per the Proceso de Registro page.

Conditions
  • Class IIb and III devices; novel devices also require clinical evidence regardless of reliance.

Effective from 2016-07-29

Anexo 2 evidence 21 similarly requires the clinical evaluation report for Class IIb/III.

Origin-country registration certificate (first requirement for imports)

dossier.origin-registration-certificate
Fact-level verified

For imported devices, the first requirement is presentation of the Certificate of Registration in the country of origin, or in a country whose regulatory program is based on the same essential requirements. Where the device is not subject to registration in the origin country, a manufacturer declaration to that effect plus evidence of circulation in that or another regulated market is accepted.

Conditions
  • Applies to imported devices; the certificate exempts the listed evidence per acápite 3.2.4 of E 86-16.

E 86-16 Anexo 2 evidence 1 requires 'Certificado(s) del Registro Sanitario del equipo o dispositivo médico en el país de origen, o declaración del fabricante'.

Technical dossier: risk management, biological, safety and metrology evidence

dossier.technical-evidence-bundle
Fact-level verified

The registration dossier (acápite 3.2.2 and Anexo 2 of E 86-16) includes: a risk-management report with an appropriately implemented risk-management plan, acceptable overall residual risk and production/post-production information methods (per ISO 14971); biological pre-clinical evidence per ISO 10993 for implants, dental, reusable and single-use devices and devices derived from biological substances; safety, environmental, parametric and metrological test reports for listed equipment categories; sterilization validation and sterilizer certificate where relevant; description of specifications and lot key; and label artwork/sample.

Conditions
  • Scope of specific items varies by device category and class; sample evaluation applies where required under the sample-evaluation regulation (E 80-15; mandatory-sample list per Resolución 46/2018 per the Proceso de Registro page).

Effective from 2016-07-29

Sample evaluation results are considered in procedures A and B (acápites 4.1.1-4.1.2).

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Manufacturer types OEM/OBL/ODM and matching QMS evidence

roles.manufacturer-oem-obl-odm
Fact-level verified

For inscription, legal manufacturers are classified as OEM (original manufacturers), OBL (owners of the name/brand) or ODM (owners of the design). Evidence scales by type: an OEM presents only its own QMS evidence; an OBL presents its QMS plus the OEM's QMS and the contractual OEM-OBL relations; an ODM presents its QMS plus that of the subcontracted production site. The inscription form (Anexo I) identifies the manufacturer type for each device in scope.

Conditions
  • Applies to device manufacturers seeking inscription under E 129-25; DMDIV operators are excluded from this regulation's scope.

Effective from 2025-05-26

If the application is filed by a suministrador, a letter from the manufacturer appointing it, signed and stamped by the manufacturer's top officer, is required (acápite 3.3.1).

Suministrador = authorized representative (may reside outside Cuba)

roles.suministrador-authorized-rep
Fact-level verified

The 'suministrador' is a natural or legal person, established in Cuba or abroad, holding a written mandate from the manufacturer (or another suministrador) to act on its behalf in tasks related to the manufacturer's obligations under Cuban legislation. E 132-25 Nota 1 states this is the authorized representative for the regulation and need not reside in Cuba.

Conditions
  • Must be inscribed with CECMED and hold a CECMED client contract to file registration applications.

Effective from 2025-07-23

E 129-25 requires inscribed suministradores to declare procedures for post-market duties (see vigilance/recall facts).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Importer accreditation (Cámara de Comercio de Cuba)

establishment.importer-accreditation
Fact-level verified

For inscription as a device importer, the applicant files the Anexo III form at CECMED's reception department together with, among other items, the document accrediting it as an importer issued by the Cámara de Comercio de Cuba, the nomenclature of products authorized to import, third-party QMS certifications if held, and declarations of procedures for import activities.

Conditions
  • Importers must additionally operate under the sanitary import/export control regime (Resolución CECMED No. 131/2015, Reglamento para el control sanitario de la importación y exportación de medicamentos, diagnosticadores, equipos, dispositivos).

Effective from 2025-05-26

Resolución 131/2015 row verified in the CECMED catalog (approved 31/07/2015, in force 28/10/2015, category Importación y Exportación).

Operator inscription prerequisite with 2-year validity and annex forms

establishment.inscription-prerequisite-2yr
Fact-level verified

Manufacturers, suministradores and importadores intending to introduce devices into the Sistema Nacional de Salud must be inscribed with CECMED; this is an indispensable prerequisite prior to any device registration application, and the inscription is valid for up to two years. Reinscription applications must be filed during the 45 natural days before expiry, and CECMED re-evaluates the same requirements. Forms: Anexo I (fabricantes), Anexo II (suministradores), Anexo III (importadores).

Conditions
  • Applies to non-IVD device operators under E 129-25 (Res. 43/2025, in force 26/05/2025, replacing E 88-18 and E 89-18).

Effective from 2025-05-26

IVD (DMDIV) operators are excluded from E 129-25 and remain under the LSOD licence system (see IVD fact).

Fees

What regulator fee applies to this class, route, event, and date?

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Fee currency: CUP for national entities, CUC for foreign entities

fees.currency-split
Fact-level verified

CECMED services are charged in Cuban Pesos (CUP) for national entities operating in that currency and in Cuban Convertible Pesos (CUC) for foreign entities and Cuban entities operating in CUC. Payment abroad is by bank transfer in any freely convertible currency (except USD) equivalent to CUC at the day's rate; payment is due only after the service application has been accepted, and all services pay 100% of the tariff upon acceptance of the application.

Conditions
  • Tariffs are per service; exchange-rate and banking costs are borne by the applicant (Art. 7).

Effective from 2017-07-31

Fee amounts in Anexo No. 1 of this 2017 edition (see typed findings for device rows).

Donation-related procedures are free of charge

fees.donation-exemption
Fact-level verified

Procedures relating to donations are not subject to CECMED service charges (Art. 3(f) of the fee Reglamento). This aligns with E 132-25 epígrafe 3.58, under which CECMED establishes regulatory requirements for device donations and controls compliance.

Conditions
  • Applies to trámites relativos a donaciones; the underlying regulatory requirements for donations still apply.

Effective from 2017-07-31

Art. 3 also exempts services not identified in the annexes and certain classification/printed-text evaluations included in other filings.

Late renewal extension: max 6 months at 20% of fee per month

fees.late-extension-penalty
Fact-level verified

In exceptional cases with sufficient justification, CECMED may authorize, at the holder's request, extension of a product or operations licence that reached expiry without renewal for reasons attributable to the client, for a limited period of up to six months. The penalty for the procedure-extension service is 20% of the procedure value for each month of extension requested. If the delay is attributable to CECMED, the validity is extended at no cost to the client.

Conditions
  • Extension of expired licences attributable to the client; separate from the standard 90-day prórroga window before expiry.

Effective from 2017-07-31

Article also allows extension of response deadlines in all trámites under the same service.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Label language: Spanish or English

label.language-spanish-english
Fact-level verified

Registration evidence must include final artwork or a photo/sample of the primary-container label, in Spanish or English, complying with the requirements of the regulations in force; Anexo 2 evidence 17 and the acápite 3.2.2 evidence list state the same for the primary packaging label.

Conditions
  • Applies to all registered devices; no other language option is provided for in E 86-16.

Effective from 2016-07-29

E 132-25 epígrafe 3.39 confirms CECMED establishes specific regulatory controls for device labelling.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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PMS: renewal requires proof of effectiveness in use; suministrador must track devices in SNS

pms.renewal-effectiveness-proof
Fact-level verified

During prórroga the manufacturer must demonstrate compliance with the same essential safety/efficacy requirements approved in the registration and additionally prove the effectiveness of the device in use during the approved validity period, taking into account the Cuban use phase. Inscribed suministradores must declare documented procedures for following devices in use in the SNS and for customer feedback, supplier evaluation and installation/maintenance support (E 129-25 acápites 4.2.4.2, 4.2.4.5, 4.2.4.6).

Conditions
  • Effectiveness proof applies at renewal; follow-up procedures are an inscription condition for suministradores.

Effective from 2016-07-27

E 86-16 Anexo B evidence 22 also requires 'Evidencia del sistema de vigilancia para el reporte de eventos adversos' at registration.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Registration forms: Anexo 1 vs Anexo 2

forms.registration-annexes
Fact-level verified

Registration applications use the Formulario de Solicitud de Registro in Anexo 1 of E 86-16 for Class I non-sterile devices that need no Cuban measuring-instrument model approval and are neither electromedanical/mechanical nor novel, and the Anexo 2 form for all other devices. Supporting evidences follow the corresponding Anexo A (with origin certificate) or Anexo B lists.

Conditions
  • Form selection is driven by class and device characteristics; Anexo 1 corresponds to Proceder A.

Effective from 2016-07-29

Submissions are received at CECMED's Departamento de Recepción y Preevaluación de Trámites; payment of the fee follows acceptance per the fee Reglamento.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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QMS audits conducted against ISO 13485

qms.iso13485-audit
Fact-level verified

In the Proceder E registration route and in the inscription process, CECMED performs the regulatory audit of the manufacturer's quality-management system against the requirements of the current ISO 13485 standard and the CECMED requirements for quality-management systems for medical device manufacturing. E 129-25 applies the terms and definitions of ISO 13485:2016 and NC ISO 13485:2018 and bases inscription on systematic evaluation of QMS compliance.

Conditions
  • Audits apply in Proceder E, in inscription/reinscription, and when the declared evidence is insufficient to identify the production site.

Effective from 2016-07-29

E 129-25 acápite 2: 'son aplicables los términos y definiciones contenidos en las normas ISO 13485:2016, NC ISO 13485:2018'.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recalls: suministradores communicate withdrawals; CECMED can cancel/seize

recall.communication-and-powers
Fact-level verified

Inscribed suministradores must have procedures to communicate to the market the field-safety notes (notas de aviso) issued by the manufacturer and the market withdrawals (retiros del mercado) carried out by the manufacturer. CECMED may cancel a marketing authorization where there are complaints about safety or performance problems, or for devices with quality problems or falsified devices, which may be retained, withdrawn, destroyed or dismantled; it also applies sanitary safety measures for non-compliance (E 132-25 epígrafes 3.52, 3.61).

Conditions
  • Cancellation/retention powers apply to devices with safety, performance, quality or falsification problems.

Effective from 2025-05-26

Communication of manufacturer notes and recalls is a declared inscription condition for suministradores.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Only inscribed manufacturers (or their inscribed suministrador) may apply

registration.applicant-inscribed-only
Fact-level verified

Per Article 41 of the Reglamento, a sanitary registration application may only be filed by manufacturers inscribed with the national regulatory authority, either directly (if they hold a CECMED client contract) or through a duly authorized suministrador representing them, which must also be inscribed and hold a CECMED client contract.

Conditions
  • Applies to all registration applications (Regulación E 86-16, in force 29/07/2016); E 129-25 (Res. 43/2025, in force 26/05/2025) now governs the underlying inscription and replaced E 88-18/E 89-18 (Resoluciones 73 y 74/2018).

Effective from 2016-07-29

The resulting registration cannot be used by a different client; a new application is required (acápite 3.1.2).

Origin-triggered regulatory audit (Proceder E)

registration.proceder-e-origin-audit
Fact-level verified

Proceder E (Complete Evaluation with Regulatory Audit) applies to sensitive devices (Anexo 4 list: infusion/transfusion sets, condoms, thermometers, sutures, intraocular lenses, X-ray tubes, orthopedic implants, gloves) of Class IIb/III from China, India, Pakistan, Russia, Latin America and new markets that are new manufacturers or new devices of an already-inscribed manufacturer; to devices from any market of a manufacturer with prior quality difficulties; and to other devices subject to import control. The audit covers the QMS and gathers registration evidence.

Conditions
  • Origin-based differential treatment applies only to sensitive Class IIb/III devices and to manufacturers with quality history.

Effective from 2016-07-29

Devices may also be grouped for registration as sets (kits), families and systems (acápite 3.1.3).

Five differentiated evaluation procedures (Procederes A-E)

registration.procedures-a-e
Fact-level verified

Registration applications are processed through one of five differentiated evaluation procedures: A - Simplified (all Class I unless sterile, measuring instruments, sensitive, electromedanical/mechanical or novel); B - Basic (Class I sterile/measuring and Class I-IIa of listed categories with valid origin-country registration); C - Complete (Class IIb, III, novel devices, devices without origin-country registration, national production); D - Simplified Update (significant updates of already-registered Class IIb/III devices of the same manufacturer); E - Complete with regulatory audit (adds QMS audit).

Conditions
  • Procedure assignment depends on class, category, sensitivity, novelty and origin; procedure determines the applicable fee level.

Effective from 2016-07-29

Anexo 5 summarizes the procedures; the CECMED 'Proceso de Registro' page maps them identically.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Cuba approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Cuba (5 records)

CubaNMPA

Prior approval / evidence record

China NMPA registration: IMDRF-member prior registration exempts evidence items (E 86-16 3.2.4)

reliance.china-nmpa-reliance-route
Pending verification
Statement

The retained official E 86-16 text, section 3.2.4, permits a current prior registration certificate from the origin country or a qualifying comparable regulatory programme (including IMDRF members) in place of specified software, biological, safety, raw-material and stability evidence. This is evidence reduction, not automatic Cuban approval. Section 4.1.2 restricts ordinary Proceder B eligibility to specified devices; China Class III does not itself establish eligibility. The regulation expressly excludes in vitro diagnostics. Current applicability still requires confirmation because the live official PDF could not be retrieved in this review.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

Current country-of-origin product registration certificate, including a qualifying NMPA Class II/III certificate for a China-made device

Target Jurisdiction Id

cuba

China Classes In Scope

General medical devices only; excludes IVDs; Cuban risk class, novelty and sensitive-device rules must be checked separately

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Current foreign product registration is required; a Class I filing is not assumed equivalent.
  • E 86-16 expressly excludes IVDs.
  • Proceder B covers its listed categories; selected IIb/III cases require CECMED case-by-case assessment. Sensitive and novel devices have separate procedures.
  • Primary text independently read from the 2026-08-26 official-source capture; currentness remains unconfirmed after live retrieval failure.
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2016-07-29

Retained official PDF SHA-256 ac391e2e881c7d576da7568b9618b658354d486bc845eda92e96cacd6cf0a8a3. Independent passage review completed 2026-09-15; live currentness not confirmed, so source-backed-partial is retained.

CubaIMDRF member authorities

Regulatory reference

Prior registration in origin/IMDRF country exempts listed evidence

reliance.imdrf-evidence-exemption
Fact-level verified

Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.

Conditions
  • Foreign registration must be current at the time of the Cuban application (Proceder B requirement).

Effective from 2016-07-29

Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.

CubaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Same route: recognised origin-country registration evidence rather than a separate reliance pathway

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 appealCECMED 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 validityCECMED 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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

CubaNMPA

Regulatory reference

CECMED reliance policy: NMPA eligibility under the WHO route remains unconfirmed

reliance.china-nmpa-not-reference
Pending verification
Statement

The cited 2023 policy refers to PAHO reference authorities, WHO-listed authorities and authorities covered by CECMED agreements. WHO subsequently included NMPA on its transitional medical-device list on 1 July 2026. Whether CECMED treats that transitional device listing as qualifying under its policy has not been established. Do not infer exclusion from the permanent medicines-authority list or from an incomplete list of cooperation instruments.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

cuba

China Classes In Scope

all regulatory functions incl. device registration (reliance practice)

Edge Type

Eligibility Unresolved

Market Access Strength

undetermined

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Requires CECMED confirmation of applicable authority-list scope and agreement coverage.
  • Distinct from the device-only E 86-16 evidence provision.
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2023-10-09

List of transitional WHO Listed Authorities for medical devices (tWLAs-MD) as of 1 July 2026

Source passage: SEGUNDO: El CECMED aplicará la Confianza Reguladora a las decisiones y procesos de las Autoridades Nacionales Reguladoras de Referencia Regional certificadas por la Organización Panamericana de la Salud, las Autoridades Listadas por la OMS, así como aquellas Autoridades Reguladoras Nacionales con las que [...]

CubaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

Registration in a country with an essential-principles programme opens proceder B and waives some test reports

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 appealCECMED 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 validityCECMED 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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Applications deemed abandoned if applicant misses deadlines

clocks.abandonment
Fact-level verified

If during a service procedure the applicant fails to meet the deadlines established in the fee Reglamento without prior agreement with CECMED, CECMED considers the procedure abandoned, cancels it and notifies in writing; to pursue it again the applicant must restart it and pay the corresponding tariff anew.

Conditions
  • Applicant-side stop rule; applies to all CECMED paid services, including device registrations.

Effective from 2017-07-31

See typed findings for the inscription review clocks under E 129-25 (60/180/30-day and 130-day clocks).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Crisis/emergency powers: depart from routine processes; fee exemptions; unregistered devices at fairs

special.crisis-flexibilities
Fact-level verified

Under E 132-25 epígrafe 3.55, in crisis or emergency situations, supply shortages or other public-health-relevant situations, CECMED may decide not to follow the regulatory processes or routine investigation procedures, and may authorize reduction or exemption of fees, taxes or tariffs. Epígrafe 3.59 allows CECMED to authorize unregistered devices for trade fairs and exhibitions. Resolución CECMED No. 119/2025 establishes rapid-response protocols for epidemics, natural disasters, energy crises and shortages of medicines, equipment and devices, derogating Circular CECMED 1/2020 and 2/2020.

Conditions
  • Extraordinary situations only; ordinary procedures apply otherwise.

Effective from 2025-07-23

Resolución 119/2025 row verified in the CECMED catalog.

Permiso de Uso Excepcional (investigators/designers; 60 working days; 2 years)

special.exceptional-use-permit
Fact-level verified

ER-16 (CECMED, 18/12/2012), based on Article 103 of the Reglamento (RM 184/2008), governs the Permiso de Uso Excepcional en Seres Humanos for investigators/designers of medical equipment linked to the SNS or priority health programs. The dossier includes the application form, justification, pilot-study plan (per NC ISO 14155), safety/efficacy evidence with risk analysis, operation/maintenance manual draft, scientific-council aval signed by at least 90% of members, and host-institution acceptance with ethics-committee aval. CECMED decides within 60 working days and the permit is valid up to two years.

Conditions
  • Route for domestically developed devices not yet registered; distinct from the priced Autorización de Uso para Propósitos Especiales for registered-import contexts (fee row A63-14).

Certificate is issued with institution, denomination, model, expediente, application, specialty and validity dates.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

After registration denial, no new application for 6 months

appeal.denial-6-month-bar
Fact-level verified

If the conformity-assessment process ends in denial of the Registro Sanitario, the manufacturer is notified with the evaluation report stating the grounds; the manufacturer may not file a new registration application for the device in question until 6 months have passed.

Conditions
  • Applies to denied device registration applications (E 86-16, acápite 4.2.3).

Effective from 2016-07-29

Reconsideration/appeal remedies are available per the fee Reglamento Art. 15-16.

Appeals: reconsideration before Director General, appeal before Minister

appeal.reconsideration-then-appeal
Fact-level verified

An interested party aggrieved by a final decision or sanction applied by CECMED may request Reconsideración of the measure before the Director General of CECMED, under the CECMED regulation 'Quejas, Reclamaciones y Reconsideración de Decisiones Reguladoras'; if the disagreement persists after CECMED's response, the party may file a Recurso de Apelación before the Minister of Public Health within the term set by that authority's rule.

Conditions
  • Two-stage administrative remedy; applies to CECMED final decisions and sanctions, including device registration decisions.

Effective from 2017-07-31

Deficiency handling operates through the priced completamiento de documentación (CD) and información adicional (IA) services (fee rows A64-14, A65-14).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

GMDN nomenclature used; UDI favored for traceability

udi.nomenclature-gmdn-udi
Fact-level verified

In exercising its functions CECMED uses the Global Medical Devices Nomenclature (GMDN) as the internationally recognized device nomenclature system, and favors the Unique Device Identification (UDI) system, as approved in national legislation, as a means to improve device traceability.

Conditions
  • Policy-level rule (E 132-25, epígrafes 3.31-3.32); no mandatory UDI deadline is stated in the sources opened.

Effective from 2025-07-23

Epígrafe 3.31: 'El CECMED, en el ejercicio de sus funciones utiliza la Nomenclatura Global de Dispositivos Médicos como sistema internacional de nomenclatura de dispositivos médicos, reconocido por la OMS.'

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Adverse events monitored via Programa de Reporte Usuario (REM)

vigilance.rem-program
Fact-level verified

CECMED, through the Programa de Reporte Usuario REM, monitors adverse events related to medical equipment and devices; upon an adverse event it must be notified using the adverse-event reporting form (Modelo de Reportes de Eventos Adversos). Reports reach the equipment vigilance unit at centinelaeqm@cecmed.cu (phones +53 7 2164364/2164365). CECMED publishes alerts typed as Alerta de Seguridad, Comunicación de Riesgo and Comunicación del Fabricante.

Conditions
  • User/health-institution reporting program; manufacturer/suministrador duties are additional.

Statutory reporting deadlines were not stated on the pages opened; E 132-25 epígrafe 3.51 makes adverse-event reporting and a post-market vigilance system mandatory under the regulations in force.

Suministradores must declare adverse-event reporting procedures

vigilance.suministrador-reporting-duty
Fact-level verified

As an inscription requirement, suministradores must present a declaration of documented procedures (with code and title) to carry out in Cuba: reporting of adverse events per CECMED regulations; follow-up of devices in use in the SNS; communication of field-safety notices (notas de aviso) issued by the manufacturer; communication of market withdrawals (retiros) carried out by the manufacturer; customer feedback; and supplier evaluation.

Conditions
  • Applies to all inscribed suministradores under E 129-25 acápite 4.2.4.

Effective from 2025-05-26

Official reporting forms are published on the CECMED modelos-reportes page (devices and IVD forms, pilot stage).

Related structured datasets

Classification systems · 1 record
Open EU-style risk classes I, IIa, IIb and III (Regulación E 117-23, Resolución No. 28/2023). →
Id

cuba:medical-device

Jurisdiction Id

cuba

Domains
  • medical-device
  • ivd
Name

EU-style risk classes I, IIa, IIb and III (Regulación E 117-23, Resolución No. 28/2023).

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

CECMED

Official Domains
  • cecmed.cu
Source Status

official-source-verified

Source Title

Regulación E 117-23 — Reglas de clasificación por riesgo para equipos y dispositivos médicos (Resolución No. 28/2023), secciones 3-4

Source Url

https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Res.No_.28.Regulaci%C3%B3n%20E%20117-23%20Reglas%20de%20clasificaci%C3%B3n%20por%20riesgo%20para%20equipos%20y%20dispositivos%20m%C3%A9dicos_0.pdf

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
  • ivd-class-axis
Notes
  • E 117-23 corresponds to EU MDR Annex VIII classification rules and GHTF/SG1/N77:2012; manufacturers classify their devices and the regulatory authority acts as judge on interpretation. It derogated Resolución BRPS No. 17/08.
  • 22 rules structured on invasiveness, active nature, duration of use and affected body areas; Rule 11: software for therapeutic/diagnostic decisions Class IIa, Class III where decisions can cause death or irreversible deterioration, Class IIb for serious deterioration or surgery; physiologically-monitoring software IIa (IIb if immediate danger); all other software Class I.
  • IVDs (diagnosticadores) are expressly excluded from E 117-23 and are registered in their own classes A, B, C and D (fee schedule rows A8-14 to A11-14).
  • Registration evaluation rigor and fees scale by risk class crossed with complexity (Procederes A-E, Regulación E 86-16 acápite 3.1.4).
Registration pathways, prior approvals and planning · 1 record
Open Cuba registration →
Country

Cuba

Jurisdiction Id

cuba

Country Code

CU

Flag

🇨🇺

Regulator

State Center for the Control of Medicines and Medical Devices

Regulator Abbrev

CECMED

Region

americas

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — Regulación E 117-23 risk-classification rules

Classes
  • Id

    registro-sanitario

    Class Name

    All classes — sanitary registration (registro sanitario)

    Pathway

    CECMED state evaluation, then certificate issued by the direction on the Certification Commission result

    Official Timeline
    Min

    90

    Max

    90

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    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

    Url

    https://www.gacetaoficial.gob.cu/sites/default/files/go_o_064_2008.pdf

    Effective Date

    2008-12-22

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    6

    Max

    12

    Unit

    months

    Notes
    • 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
    • The 90 working days stop at the Commission, and neither Art. 57 nor Art. 59 puts a period on the Commission or on the direction that signs the certificate, so it is the review clock rather than a decision date
    • Art. 56: a notification of evaluation stops the file, and no answer within 30 working days denies it of office
    • Rigour rises with risk class through the procederes A to D of Regulación E 86-16, but the periods do not: A covers most Class I, B adds sterile, dental, electromedical and IVD devices and repeat suppliers, C and D cover Class IIb, III and novel devices
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    prorroga

    Class Name

    All classes — renewal (prórroga del registro)

    Pathway

    CECMED re-evaluation before the five-year certificate expires

    Official Timeline
    Min

    60

    Max

    60

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    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

    Url

    https://www.gacetaoficial.gob.cu/sites/default/files/go_o_064_2008.pdf

    Effective Date

    2008-12-22

    Accessed Date

    2026-08-30

    Realistic Timeline
    Min

    4

    Max

    9

    Unit

    months

    Notes
    • Art. 57 gives the renewal technical report 60 working days rather than 90
    • Art. 58 bases the renewal on continued conformity with the essential requirements as shown by the device in use
    • If no renewal application is filed by the expiry date the CECMED cancels the registration outright (E 86-16 §4.3)
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

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)
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    Registration in a country with an essential-principles programme opens proceder B and waives some test reports

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Same route: recognised origin-country registration evidence rather than a separate reliance pathway

Local Rep Required

Yes

Local Rep Name

Suministrador inscribed with CECMED (need not be resident in Cuba)

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

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 case

Last Updated

2026-08-30

Verification Status

partially-verified

Official Sources
  • Title

    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

    Url

    https://www.gacetaoficial.gob.cu/sites/default/files/go_o_064_2008.pdf

    Effective Date

    2008-12-22

    Accessed Date

    2026-08-30

  • Title

    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

    Url

    https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/regulacion_e_86-16.pdf

    Effective Date

    2016-07-29

    Accessed Date

    2026-08-30

  • Title

    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

    Url

    https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Res.No_.%2043.Aprobar%20y%20poner%20en%20vigor%20E%20129-25_0.pdf

    Accessed Date

    2026-08-30

Reviewed On

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather 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).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to CECMED including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    CECMED reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. CECMED may issue questions.

    Duration

    90 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, CECMED issues Cuba market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Cuba fees →
Jurisdiction Id

cuba

Country

Cuba

Country Code

CU

Authority

CECMED

Low Risk Local
Min

21340

Max

26370

Currency

CUP

Per Product

Yes

High Risk Local
Min

33405

Max

38945

Currency

CUP

Per Product

Yes

Details
  • Id

    registration-class-i-high-complexity

    Item

    Registration - Class I, high complexity

    Currency

    CUP

    Amount Local

    26370

    Amount Local Formatted

    CUP 26,370

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-i-low-complexity

    Item

    Registration - Class I, low complexity

    Currency

    CUP

    Amount Local

    21340

    Amount Local Formatted

    CUP 21,340

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-iia-high-complexity

    Item

    Registration - Class IIa, high complexity

    Currency

    CUP

    Amount Local

    32910

    Amount Local Formatted

    CUP 32,910

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-iia-low-complexity

    Item

    Registration - Class IIa, low complexity

    Currency

    CUP

    Amount Local

    28885

    Amount Local Formatted

    CUP 28,885

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-iib-high-complexity

    Item

    Registration - Class IIb, high complexity

    Currency

    CUP

    Amount Local

    34920

    Amount Local Formatted

    CUP 34,920

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-iib-low-complexity

    Item

    Registration - Class IIb, low complexity

    Currency

    CUP

    Amount Local

    33405

    Amount Local Formatted

    CUP 33,405

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    registration-class-iii-high-complexity

    Item

    Registration - Class III, high complexity

    Currency

    CUP

    Amount Local

    38945

    Amount Local Formatted

    CUP 38,945

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-i-high-complexity

    Item

    Renewal - Class I, high complexity

    Currency

    CUP

    Amount Local

    15220

    Amount Local Formatted

    CUP 15,220

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-i-low-complexity

    Item

    Renewal - Class I, low complexity

    Currency

    CUP

    Amount Local

    12805

    Amount Local Formatted

    CUP 12,805

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-iia-high-complexity

    Item

    Renewal - Class IIa, high complexity

    Currency

    CUP

    Amount Local

    19745

    Amount Local Formatted

    CUP 19,745

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-iia-low-complexity

    Item

    Renewal - Class IIa, low complexity

    Currency

    CUP

    Amount Local

    17330

    Amount Local Formatted

    CUP 17,330

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-iib-high-complexity

    Item

    Renewal - Class IIb, high complexity

    Currency

    CUP

    Amount Local

    20950

    Amount Local Formatted

    CUP 20,950

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-iib-low-complexity

    Item

    Renewal - Class IIb, low complexity

    Currency

    CUP

    Amount Local

    20045

    Amount Local Formatted

    CUP 20,045

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

  • Id

    renewal-class-iii-high-complexity

    Item

    Renewal - Class III, high complexity

    Currency

    CUP

    Amount Local

    23365

    Amount Local Formatted

    CUP 23,365

    Frequency

    Per device renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Source Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Source Effective Date

    2024-09-18

    Verified On

    2026-08-25

Notes
  • CECMED Resolution 98/2024 publishes the exact AC-Q registration and renewal rows and states the tariff unit is CUP.
  • Kit, family, system, modification, and dossier-completion add-ons are separate rows in the linked official schedule.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    CECMED Resolution 98/2024: medical-device registration and renewal tariff rows

    Url

    https://www.cecmed.cu/file/13252/download?token=qiiUc35B

    Effective Date

    2024-09-18

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Cuba certifications →
Slug

cuba

Market

Cuba

Confidence

low

Schemes
  • Id

    mincom-homologation-or-acceptance-certificate

    Name

    MINCOM homologation or acceptance certificate

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Telecommunications Or Ict Equipment

    Note

    Resolución 2 de 2026 of the Ministry of Communications, published in Gaceta Oficial No. 66 Extraordinaria of 21 May 2026 and in force sixty days later, replaced Resoluciones 132/2019 and 110/2020. Article 19 subjects telecommunications and ICT equipment imported commercially by legal persons that connects to public networks or uses radio spectrum to homologation, with a certificate issued by the Dirección General de Comunicaciones; article 11.2 gives equipment outside that scope a certificado de aceptación instead. EMC is folded in rather than separate: article 23(c) requires compliance with the technical standards guaranteeing electromagnetic compatibility. Foreign certificates may be accepted at the Dirección General's discretion under article 42(c) to (e), certificates last at most five years under article 48, and the fee is 1,200 CUP or USD 50 under article 40.1.

    Source Urls
    • https://www.gacetaoficial.gob.cu/sites/default/files/goc-2026-ex66.pdf
    Source Binding

    reviewed

  • Id

    mincom-autorizacion-tecnica-for-import

    Name

    MINCOM autorización técnica presented to customs

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Commercial Importer

    Note

    Article 3 of Resolución 2 de 2026 requires a MINCOM autorización técnica, presented to the customs authority, for commercial import of the equipment listed in Anexo I, and article 7 requires the application at least thirty days before arrival. Article 21 makes the homologation or acceptance certificate a precondition of that authorisation, and article 24 confirms neither certificate authorises the provision of telecommunications services. There is an unresolved tension on the face of the instrument that is worth putting to the authority in writing: Anexo I and Anexo II are driven by tariff subheadings and cover headings 8517, 8518, 8525 to 8529, 8531 and others, with Chapter 90 — where 9018, 9019, 9021 and 9022 medical devices sit — appearing nowhere, while article 19's homologation duty is drafted functionally by reference to network connection and spectrum use. Article 18 separately makes a guaranteed after-sales service capability an indispensable condition of the authorisation for some equipment types.

    Source Urls
    • https://www.gacetaoficial.gob.cu/sites/default/files/goc-2026-ex66.pdf
    Source Binding

    reviewed

  • Id

    lrn-recognised-standards-including-oiml

    Name

    Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence

    Category

    Legal Metrology

    Status

    Evidence Only No Separate Certificate

    Object

    Registration Dossier

    Note

    Resolución CECMED 111/2025 of 22 December 2025 approved Regulación DM 102-25, edition 20 of the Lista Regulatoria de Normas, replacing Resolución 124/2024. The list is the set of standards CECMED recognises for demonstrating conformity with the essential principles of safety and performance, used in the processes leading to the marketing authorisation. IEC 60601-1 and its particular standards, IEC 60601-1-2 for EMC, IEC 60825-1 for laser safety and a set of OIML recommendations including R 148 for non-invasive non-automated sphygmomanometers all sit inside it, so electrical safety, EMC, laser safety and measuring-instrument requirements are dossier evidence in the CECMED registration rather than separate Cuban certificates. This does not rule out a separate national legal-metrology regime under ONN or INIMET, whose sites could not be reached.

    Source Urls
    • https://www.cecmed.cu/file/185/download?token=g4MeeZwu
    Source Binding

    candidate

  • Id

    medical-electrical-and-standards-evidence

    Name

    Medical electrical and standards evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Standards are voluntary (ER-9-2012 §4: observance not obligatory); the Lista Regulatoria de Normas has priority for evaluating conformity with the essential requirements, is updated annually (current edition DM 102-25 Edición 20 per Resolución CECMED 111/2025) and alternatives are accepted if justified. E 86-16 dossier evidence includes ISO 10993 biological pre-clinical reports for listed categories (implants, dental, reusable instruments, single-use, biological-substance devices), sterilization-method validation, ISO 14971 risk management and QMS audits per ISO 13485 / NC ISO 13485:2018.

    Source Binding

    unresolved

  • Id

    metrology-model-approval-and-test-reports

    Name

    Metrology model approval and test reports

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Measuring Instrument Or Listed Device Category

    Note

    Measuring instruments require Cuban Aprobación de Modelo (model approval); class I devices needing such approval are excluded from the simplified Anexo 1 route (E 86-16 acápite 3.1.4). Anexo 2 evidence 13 requires safety, environmental, parametric and metrological test reports per applicable standards for listed categories (implants, anesthesia/ventilation, dental, electromedical, hospital hardware, active diagnostic, optical, radiation equipment).

    Source Urls
    • https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/regulacion_e_86-16.pdf
    Source Binding

    candidate

Official Sources
  • Authority

    Gaceta Oficial de la República de Cuba

    Topic

    Resolución 2 de 2026 MINCOM (GOC-2026-325-EX66) — homologation, acceptance and autorización técnica

    Url

    https://www.gacetaoficial.gob.cu/sites/default/files/goc-2026-ex66.pdf

  • Authority

    CECMED

    Topic

    Resolución 111/2025 — Regulación DM 102-25 Lista Regulatoria de Normas, edición 20

    Url

    https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Res.No_.111%20Regulacion%20DM%20102-25_compressed.pdf

  • Authority

    CECMED

    Topic

    ER-9-2012 essential requirements and Lista Regulatoria de Normas

    Url

    https://www.cecmed.cu/file/185/download?token=g4MeeZwu

  • Authority

    CECMED

    Topic

    E 86-16 registration evidence including metrological test reports

    Url

    https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/regulacion_e_86-16.pdf

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