Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need ARRN prior authorisation for ionizing-radiation sources and generating equipment in Paraguay?
Describe your device to check whether ARRN prior authorisation for ionizing-radiation sources and generating equipment may apply, why, what facts are missing, and which official source to review.
1 maintained routes2 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 ARRN prior authorisation for ionizing-radiation sources and generating 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.
Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.
- Requirement family
- Ionizing radiation and radioactive sources
- Regulatory object
- ionizing radiation generating equipment
- Maintained rule status
- mandatory if feature
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
Ley N° 5169/2014 Art. 7 provides that without the prior authorisation of the Autoridad Reguladora Radiológica y Nuclear no source may, as applicable, be designed, manufactured, acquired, imported or exported, distributed, sold, possessed, installed, used or operated, and Art. 8(d) gives the ARRN the power to authorise, suspend or revoke authorisations for all the activities of Art. 5 in respect of radioactive sources or ionizing-radiation generating equipment. The ARRN publishes the corresponding procedures and forms, including an inscription certificate for import and export and a specific procedure for importing ionizing-radiation sources. X-ray, CT and radiotherapy equipment therefore needs an ARRN authorisation on top of DINAVISA registration, and IVD radioassay kits carry the same label warning under Resolución DINAVISA N° 266/2022.
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.
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 Paraguay routes to check
Electrical safety
DINAVISA device registration dossier — quality and finished-product conformity evidence
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
CONATEL homologation — equipment that makes use of the radioelectric spectrum
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Telecom terminal
CONATEL homologation — equipment connectable to the public telecommunications network
Applies when the product, feature, component, or use is in scope.
Source association reviewed
EMC
CONATEL radiofrequency-emissions limits — declaration instead of homologation
Evidence may be required, but the matrix does not identify a generic separate certificate.
Source association reviewed
Metrology
INTN Organismo Nacional de Metrología — model approval, importer registration and periodic verification of regulated measuring instruments
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Reviewed source associations
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.
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 Paraguay scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
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 Paraguay?
- 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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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