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Does my medical device need Radiation-authority authorisation for controlled biomedical equipment in Colombia?

Describe your device to check whether Radiation-authority authorisation for controlled biomedical equipment may apply, why, what facts are missing, and which official source to review.

4 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 Radiation-authority authorisation for controlled biomedical equipment 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: radiation emitting controlled biomedical equipment
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Decreto 4725 de 2005 Art. 23: equipos biomédicos de tecnología controlada that use radiation must hold an authorisation issued by the competent radiation authority for the handling of that equipment, in addition to the INVIMA commercialisation permit. Legal metrology was not opened in this pass.

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 Colombia routes to check

Check every Colombia route →

Electrical safety

INVIMA electrical/EMC evidence

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

Telecom terminal

CRC mobile-terminal homologation

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

Environmental / battery

RAEE producer collection system for electromedical AEE

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.

Función Pública (Gestor Normativo)

Decreto 4725 de 2005 Art. 23 radiation authorisation for controlled biomedical equipment

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 Colombia 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 Colombia?: 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.