Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksArmenia medical device certification and licence checker
Check Armenia requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
8 maintained routes12 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.
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
Medical device certification routes in Armenia
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
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
Official starting points
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.
Ministry of Health of the Republic of Armenia
Procedure and document list for the medical-device import (conformity) certificate — Government Decree No. 429-Ն of 30 March 2023
Eurasian Economic Commission
TR TS 004/2011 low-voltage equipment safety — Article 1(2) excludes medical products
Eurasian Economic Commission
TR TS 020/2011 electromagnetic compatibility of technical means — Article 1(2) exclusions carry no medical line
Eurasian Economic Commission
TR EAEU 037/2016 on restriction of hazardous substances — Article 3 excludes measuring instruments and medical devices
Government of the Republic of Armenia
Government Decision No. 1728-Ն of 21 October 2021 invalidating all protocol decisions from 1 January 2022 — no extended-producer-responsibility regime in force
Government of the Republic of Armenia
Technical regulation of radio equipment and telecommunications terminal equipment — Government Decree No. 2228-Ն of 15 December 2005
Public Services Regulatory Commission
Law on Electronic Communications ՀՕ-176-Ն of 8 July 2005, Article 17 — radio-frequency use permits
Public Services Regulatory Commission
Decision No. 169-Ն of 13 April 2011 — procedure for granting radio-frequency use permits and the exempt categories
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
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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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