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CECMED · Americas

Cuba medical device regulatory resources

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1,560 registration records7 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device registration database

Search official CECMED device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

AI medical device classifier

Describe your device and get a preliminary CECMED risk class with an explanation and source links.

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.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Cuba. Each question separates published rules from details still awaiting verification.

Structured regulatory requirements

Explore all 42 source-linked facts →

23 of 25 research dimensions currently covered · 21 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
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…
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…
3 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
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…
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…
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…
Origin-triggered regulatory audit (Proceder E)
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…
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…
3 source-linked facts
Checked 2026-09-15
Open details →
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
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…
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…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Clinical evaluation report required for Class IIb/III
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 devi…
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…
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
Open details →
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
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…
Renewal application window: 90 days before expiry
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, cancella…
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
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…
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…
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
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…
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…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (14 lines) →

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

Fee lineAmountProvenance
Registration - Class I, high complexityCUP 26,370Verified
Registration - Class I, low complexityCUP 21,340Verified
Registration - Class IIa, high complexityCUP 32,910Verified
Registration - Class IIa, low complexityCUP 28,885Verified
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 / pathwayReview clockPlanning totalProvenance
All classes — sanitary registration (registro sanitario)(CECMED state evaluation, then certificate issued by the direction on the Certification Commission result)

Art. 57: conformity assessment ends with a technical report put before the Certification Commission within 90 working days; Art. 52 puts the documentary-review notification at 10 working days from receipt

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

90 working days6-12 monthsVerified
All classes — renewal (prórroga del registro)(CECMED re-evaluation before the five-year certificate expires)

Art. 57 gives the renewal technical report 60 working days rather than 90

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)

60 working days4-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(90 working days)
  5. 5Registration Approval(1-2 weeks)

Registry insights

Full registry statistics →

Computed from 1,560 official CECMED registration records · data as of 2025-01-30

New registrations by year
2019202020212022202320242025
VerifiedCECMED registry · as of 2025-01-30
1,560
Registrations
536
Manufacturers
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