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Does my medical device need Atomic-energy activity licence and source registration for ionizing-radiation equipment in Armenia?

Describe your device to check whether Atomic-energy activity licence and source registration for ionizing-radiation 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 Atomic-energy activity licence and source registration for ionizing-radiation equipment check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.

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: radiation emitting equipment
Maintained rule status: mandatory for use site
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Article 18(1) of the Law on Safe Use of Atomic Energy for Peaceful Purposes (ՀՕ-285) makes it a licensed activity to use and adjust generating radiation sources (point ե) and to manufacture, use, repair, assemble, adjust, transport or store devices containing radioactive material (point դ). Article 21(1) requires ionizing-radiation sources subject to safety regulation to be state-registered, accounted for and controlled. Section 13 of the licensed-activities table in Article 43(2) of the Law on Licensing (ՀՕ-193 of 30 May 2001), entries 4, 5 and 6, carries the same three activities. The Nuclear Safety Regulatory Committee's own guidance states that X-ray equipment is an ionizing-radiation source, so a hospital imaging installation triggers the licence and the per-source registration. The duty falls on the operator at the use site, not on the device importer.

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

Metrology

Legal metrology type approval and verification

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.

Nuclear Safety Regulatory Committee

Law on Safe Use of Atomic Energy for Peaceful Purposes ՀՕ-285, Articles 18(1) and 21(1) — activity licensing and registration of ionizing-radiation sources

Government of the Republic of Armenia

Law on Licensing ՀՕ-193 of 30 May 2001, Article 43(2) section 13 — atomic-energy activities subject to licence

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.