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Does my medical device need DS 133 ionizing-generator and radioactive-substance authorisation in Chile?

Describe your device to check whether DS 133 ionizing-generator and radioactive-substance authorisation may apply, why, what facts are missing, and which official source to review.

6 maintained routes7 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 DS 133 ionizing-generator and radioactive-substance authorisation check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.

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

Decreto Supremo N° 133/1984 Art. 2° forbids radioactive installations or equipment that generates ionizing radiation from operating without prior authorisation of the Health Service of the territory (the environmental health service in the Región Metropolitana). Art. 3° requires an individual authorisation for anyone who works in those installations or operates such equipment and is exposed. Art. 4° forbids acquiring, possessing, using, storing, importing, exporting, distributing or selling radioactive substances without the corresponding sanitary authorisation. This is a use-site and substance gate, not an ISP product-registration certificate.

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 Chile routes to check

Check every Chile route →

Electrical safety

ISP NCh-norm documentary verification

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

Product-specific

Product-specific IEC and sterility certificates

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

Wireless / radio

SUBTEL short-range radio certificate or QR marking

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

Adapters / components

SEC protocol certification before commercialisation

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

Environmental / battery

REP producer registration for AEE and batteries

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.

Biblioteca del Congreso Nacional de Chile

Decreto Supremo N° 133/1984 Arts. 2-4 ionizing-generator and radioactive-substance authorisation

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 Chile 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 Chile?: 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.