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Does my medical device need Decree 24037-S ionising-radiation construction, import and operation authorisation in Costa Rica?

Describe your device to check whether Decree 24037-S ionising-radiation construction, import and operation authorisation may apply, why, what facts are missing, and which official source to review.

3 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 Decree 24037-S ionising-radiation construction, import and operation authorisation check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: ionizing source or generator
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Decreto Ejecutivo 24037-S (Reglamento sobre protección contra las radiaciones ionizantes), SCIJ nValor2=15464. Art. 8 classifies medical therapy installations and medical diagnostic X-ray whose design operating potential exceeds 70 kV as Tipo I, and dental radiography as Tipo III. Art. 10 requires prior competent-authority authorisation for construction, operation and, where applicable, closure of Tipo I installations (mobile radioactive equipment needs operation and closure only). Art. 43 requires an import authorisation before any ionising source or generator enters the country. Art. 93 requires quality-control programmes for every source or generator used in medical practice, at the periodicity set in the sanitary operating permit. RTCR 505:2022 numerales 10.12 and 11.6 still require that authorisation to sit in the EMB registration file.

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 Costa Rica routes to check

Check every Costa Rica route →

Electrical safety

Medical electrical evidence

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

Wireless / radio

SUTEL mobile-terminal or free-band homologation

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.

Procuraduría General de la República (SCIJ)

Decreto Ejecutivo 24037-S Arts. 8, 10, 43 and 93

Ministerio de Salud

RTCR 505:2022 registration dossier radiation and IVD requirements

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 Costa Rica 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 Costa Rica?: 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.