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Does my medical device need INDOCAL legal-metrology model approval, batch examination and verification in Dominican Republic?

Describe your device to check whether INDOCAL legal-metrology model approval, batch examination and verification 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 INDOCAL legal-metrology model approval, batch examination and verification 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.

Art. 39 of the Ley No. 166-12 (SIDOCAL) makes INDOCAL the national authority responsible for the technical operations of legal or regulatory metrology; Art. 60 gives it the powers of verification and certification of the instruments and equipment used to weigh or measure throughout the national territory and Art. 61 sets out its legal-metrology competence, including the approval of models and the verification that determines whether an instrument's error is within the permitted limits; Art. 110 assigns market inspection in legal metrology to Pro Consumidor, which checks that instruments carry INDOCAL's approval and verification, and Art. 112 makes the sale of unverified instruments a sanctionable breach. INDOCAL's Tarifa de Servicios (Resolución CD-01-2022, adopted 12 July 2022) prices the device-relevant operations: approval of a model of measuring instrument subject to metrological control (RTM-001) at RD$15,000.00, examination of a clinical-thermometer model at RD$27,000.00, batch examination of glass liquid-in-glass clinical thermometers at RD$15.00 per unit up to 500 units (RD$10.00 up to 35,000, RD$7.00 above) and of digital and radiation thermometers at RD$25.00 per unit up to 500 (RD$15.00 up to 35,000, RD$10.00 above), and the sale of a repair seal at RD$450.00. Clinical thermometers are therefore a medical device expressly inside the legal-metrology regime.

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 Dominican Republic routes to check

Check every Dominican Republic route →

Electrical safety

Medical electrical safety and EMC evidence inside the sanitary registration

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

Source association reviewed

Radiation

CNE import permit for radioactive sources and ionizing-radiation-emitting devices

Handled as an import or shipment-level obligation.

Source association reviewed

Radiation

CNE institutional operating licence and radiological protection officer licence

Applies to the facility, operator, or installation rather than only the product.

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.

INDOCAL

Ley No. 166-12 (SIDOCAL) — INDOCAL as legal-metrology authority

INDOCAL

Tarifa de Servicios, Resolución CD-01-2022 — metrology and conformity-assessment tariffs

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 Dominican Republic 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 Dominican Republic?: 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.