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 DINAVISA device registration dossier — quality and finished-product conformity evidence in Paraguay?
Describe your device to check whether DINAVISA device registration dossier — quality and finished-product conformity evidence may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 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 DINAVISA device registration dossier — quality and finished-product conformity evidence check is screening
Checks whether electrical safety is dossier evidence or a separate national product certificate. Evidence is normally handled inside the medical-device registration route.
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
- Medical electrical safety
- Regulatory object
- finished device
- Maintained rule status
- included in medical registration
- Useful product facts
- Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.
There is no separate Paraguayan electrical-safety or EMC certificate for a medical device: the evidence is filed inside the sanitary-registration dossier. Resolución DINAVISA N° 226/2024 Art. 6(a) requires the manufacturer's Good Manufacturing Practice certificate or its equivalent — an ISO 13485, CE, UL or FDA-issued quality certificate — and Art. 6(e) requires a quality-control certificate for the finished product covering every test that guarantees the device's functionality, quality and safety under the applicable standards, or a product conformity certificate. The dossier runs through the DINAVISAPy platform, and DINAVISA retains in-situ inspection and cancellation powers.
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
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
Radiation
ARRN prior authorisation for ionizing-radiation sources and generating equipment
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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