🇨🇺 Cuba medical device regulatory data

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.

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.

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).

Regulación E 132-25 'Política del CECMED para la regulación de los dispositivos médicos', approved by Resolución No. 63/2025 of 23/07/2025 and in force from its publication in Boletín Ámbito Regulador No. 00-513, covers all medical devices including IVDs (DMDIV). It renames 'equipo médico' to 'dispositivo médico' and the former 'Registro' process to 'Autorización de Comercialización'; pre-existing regulaciones will be updated progressively.

Resolución CECMED No. 22/2020 (Boletín Ámbito Regulador No. 00-365, 03/04/2020) approved, on a transitory basis, modifications to the requirements of the Reglamento para la Evaluación y el Control Estatal de Equipos Médicos during the COVID-19 pandemic, including keeping in-course inscription audits pending and extending BPM and free-sale certificates to 31/10/2020; it entered into force on the date of signature.

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.

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.

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.

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).

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

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).

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.

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.

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).

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.

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.

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.