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Does my medical device need Legal metrology type approval and verification in Armenia?

Describe your device to check whether Legal metrology type approval 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 Legal metrology type approval 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: 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.

Article 9.1(1) of the Law on Ensuring Uniformity of Measurements (ՀՕ-22-Ն of 8 February 2012) subjects measuring instruments listed for legal metrological control to type approval, and Article 9.2(1) subjects them to verification, which is recurring. Article 6(3) forbids the use of an instrument whose type is not approved and which has not passed verification. The list annexed to Government Decree No. 113-Ն of 11 February 2016 names ninety instrument types including thermometers, electrocardiographs, electromyographs, pulse oximeters, dosimeters, cardiac monitors and haemodialysis machines, so a device that measures is in scope independent of its medical registration. The authorised body is the Ministry of Economy and the national metrology body is the National Body for Standardisation and Metrology.

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 Armenia routes to check

Check every Armenia route →

Import CoC / PVoC

Medical-device import (conformity) certificate

Handled as an import or shipment-level obligation.

Source association reviewed

Electrical safety

TR TS 004/2011 low-voltage equipment safety — medical devices excluded

Evidence may be required, but the matrix does not identify a generic separate certificate.

Source association reviewed

EMC

TR TS 020/2011 electromagnetic compatibility of technical means

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

Source association reviewed

Environmental / battery

TR EAEU 037/2016 hazardous-substance restriction — medical devices and measuring instruments excluded

Evidence may be required, but the matrix does not identify a generic separate certificate.

Source association reviewed

Wireless / radio

Radio equipment and terminal equipment conformity certificate

Maintained as a mandatory pre-market route.

Source association reviewed

Wireless / radio

Public Services Regulatory Commission radio-frequency use permit

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

Source association reviewed

Radiation

Atomic-energy activity licence and source registration for ionizing-radiation equipment

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.

National Body for Standardisation and Metrology / Ministry of Economy

Law on Ensuring Uniformity of Measurements ՀՕ-22-Ն of 8 February 2012, Articles 6(3), 9.1 and 9.2 — type approval and verification

Government of the Republic of Armenia

Government Decree No. 113-Ն of 11 February 2016 — list of measuring instruments subject to legal metrological control

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 Armenia 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 Armenia?: 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.