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 IBMETRO legal metrology — periodic verification of weighing instruments used in health establishments in Bolivia?
Describe your device to check whether IBMETRO legal metrology — periodic verification of weighing instruments used in health establishments 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 IBMETRO legal metrology — periodic verification of weighing instruments used in health establishments check is screening
Checks whether a clinical measuring function needs model approval or initial/periodic verification. 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
- Legal metrology
- Regulatory object
- regulated measuring instrument
- Maintained rule status
- mandatory if feature
- Useful product facts
- Measured quantity, clinical decision use, units, accuracy claim, and whether the value drives treatment.
IBMETRO's Dirección de Metrología Legal verifies the measuring instruments, equipment and products whose use can affect commercial transactions, health, the economy, security or the environment, under Decreto Ley N° 15380 (Ley Nacional de Metrología). Its published verification pages name weighing instruments (balanzas and básculas) used in commercial transactions, custody transfer and health as subject to periodic verification, and list hospitals and diagnostic centres among the rubros in which those instruments must be verified; the same directorate verifies net content, service stations and volumetric meters. Clinical and laboratory weighing equipment used in a health establishment therefore carries a periodic IBMETRO verification separate from the AGEMED registration.
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 Bolivia routes to check
Electrical safety
AGEMED device registration dossier — quality-system certificate and technical documentation
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Import CoC / PVoC
AGEMED imported-device dossier — consularised certificate of free sale from the origin authority
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
ATT homologation — telecommunications and ICT equipment using the radioelectric spectrum
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Telecom terminal
ATT homologation — terminal equipment connected to public telecommunications networks
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 Bolivia 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 Bolivia?
- 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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