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Does my medical device need Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence in Cuba?

Describe your device to check whether Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence may apply, why, what facts are missing, and which official source to review.

5 maintained routes4 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this Lista Regulatoria de Normas as the route for safety, EMC and metrology evidence check is screening

Checks whether a clinical measuring function needs model approval or initial/periodic verification. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family: Legal metrology
Regulatory object: registration dossier
Maintained rule status: evidence only no separate certificate
Useful product facts: Measured quantity, clinical decision use, units, accuracy claim, and whether the value drives treatment.

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.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Cuba routes to check

Check every Cuba route →

Wireless / radio

MINCOM homologation or acceptance certificate

Applies when the product, feature, component, or use is in scope.

Import CoC / PVoC

MINCOM autorización técnica presented to customs

Handled as an import or shipment-level obligation.

Electrical safety

Medical electrical and standards evidence

Evidence is normally handled inside the medical-device registration route.

Metrology

Metrology model approval and test reports

Applies when the product, feature, component, or use is in scope.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

CECMED

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

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Cuba scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Cuba?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.