CECMED market access

Cuba medical device registration resources

Research CECMED registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Cuba medical device resource.

1,560 registration records7 free resources23/25 requirements coveredAug 2026 fees reviewed

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Medical device registration database

Search official CECMED device registration records.

Medical device registry insights

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AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Cuba requirements.

AI similar registered product finder

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Government registration fees

Review current CECMED medical-device fee evidence and official tariff availability.

Registration timeline

The working-day periods Cuba's 2008 device reglamento puts on CECMED review, and where they stop.

Structured regulatory requirements

Explore all 40 source-linked facts →

23 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: 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 wa…
Base regulation (Reglamento, RM 184/2008): 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 Ordin…

3 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Umbrella device policy E 132-25 (2025) and terminology transition: 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 Ámbit…
COVID-19 transitory modification of Reglamento requirements (Res. 22/2020): 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…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition (E 132-25, 2.13): 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…
IVD definition (DMDIV) and diagnosticador terminology: 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 i…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Only inscribed manufacturers (or their inscribed suministrador) may apply: 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 CE…
Five differentiated evaluation procedures (Procederes A-E): Registration applications are processed through one of five differentiated evaluation procedures: A Simplified (all Class I unless sterile, measuring instruments, sensitive, electromedanica…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Prior registration in origin/IMDRF country exempts listed 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 essenti…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Manufacturer types OEM/OBL/ODM and matching QMS evidence: 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 o…
Suministrador = authorized representative (may reside outside Cuba): 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 rel…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Operator inscription prerequisite with 2-year validity and annex forms: 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…
Importer accreditation (Cámara de Comercio de Cuba): 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 is…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Origin-country registration certificate (first requirement for imports): 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 essent…
Technical dossier: risk management, biological, safety and metrology evidence: 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 a…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Registration forms: Anexo 1 vs Anexo 2: 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 ne…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Label language: Spanish or English: 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…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS audits conducted against ISO 13485: 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 cur…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

MINCOM homologation or acceptance certificate: Wireless / radio
MINCOM autorización técnica presented to customs: Import CoC / PVoC
Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence: Metrology

5 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Registration - Class I, high complexity: CUP 26,370
Registration - Class I, low complexity: CUP 21,340

14 maintained fee lines · 3 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

All classes — sanitary registration (registro sanitario) · CECMED state evaluation, then certificate issued by the direction on the Certification Commission result: 90 working days
All classes — renewal (prórroga del registro) · CECMED re-evaluation before the five-year certificate expires: 60 working days

2 maintained pathways · 1 related fact

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Registration valid up to 5 years; cancelled if no renewal request: 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) fo…
Renewal adds 5 years; total registration+renewal capped at 10 years: 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 regist…

3 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Significant modifications require new registration; others classified by CECMED: 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 requir…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

GMDN nomenclature used; UDI favored for traceability: In exercising its functions CECMED uses the Global Medical Devices Nomenclature (GMDN) as the internationally recognized device nomenclature system, and favors the Unique Device Identificat…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

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

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

Permiso de Uso Excepcional (investigators/designers; 60 working days; 2 years): 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 li…
Crisis/emergency powers: depart from routine processes; fee exemptions; unregistered devices at fairs: 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 rou…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

PMS: renewal requires proof of effectiveness in use; suministrador must track devices in SNS: During prórroga the manufacturer must demonstrate compliance with the same essential safety/efficacy requirements approved in the registration and additionally prove the effectiveness of th…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Adverse events monitored via Programa de Reporte Usuario (REM): 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 repo…
Suministradores must declare adverse-event reporting procedures: 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 regulat…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Recalls: suministradores communicate withdrawals; CECMED can cancel/seize: 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 mercad…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Promotion/advertising control and reporting form: 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 additio…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeals: reconsideration before Director General, appeal before Minister: 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…
After registration denial, no new application for 6 months: 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 n…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (14 lines) →

CECMED registration fees in CUP · reviewed 2026-08-25

Fee line	Amount	Provenance
Registration - Class I, high complexity	CUP 26,370	Verified
Registration - Class I, low complexity	CUP 21,340	Verified
Registration - Class IIa, high complexity	CUP 32,910	Verified
Registration - Class IIa, low complexity	CUP 28,885	Verified

10 more fee lines on the full schedule · 14 of 14 rows source-verified

Registration timeline

Full registration timeline →

State Center for the Control of Medicines and Medical Devices (CECMED) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — Regulación E 117-23 risk-classification rules classification

Class / pathway	Review clock	Planning total	Provenance
All classes — sanitary registration (registro sanitario)(CECMED state evaluation, then certificate issued by the direction on the Certification Commission result)	90 working days	6-12 months	Verified
All classes — renewal (prórroga del registro)(CECMED re-evaluation before the five-year certificate expires)	60 working days	4-9 months	Verified