CECMED · structured requirements

🇨🇺 Cuba IVD regulatory data

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

1 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Cuba

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Reliance & recognition

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

Compare countries

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 (3 records)

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 appeal CECMED Regulación E 86-16, Evaluación Estatal de Equipos y Dispositivos Médicos (in force 29/07/2016) — procederes A to D by risk class, §4.2 outcomes, §4.3 registration validity CECMED 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 appeal CECMED Regulación E 86-16, Evaluación Estatal de Equipos y Dispositivos Médicos (in force 29/07/2016) — procederes A to D by risk class, §4.2 outcomes, §4.3 registration validity CECMED 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

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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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