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 TR TS 004/2011 low-voltage equipment safety — medical devices excluded in Armenia?
Describe your device to check whether TR TS 004/2011 low-voltage equipment safety — medical devices excluded may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 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 TR TS 004/2011 low-voltage equipment safety — medical devices excluded check is screening
Checks whether electrical safety is dossier evidence or a separate national product certificate. Evidence may be required, but the matrix does not identify a generic separate certificate.
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
- Medical electrical safety
- Regulatory object
- finished device
- Maintained rule status
- evidence only no separate certificate
- Useful product facts
- Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.
TR TS 004/2011 (Customs Union Commission Decision No. 768 of 16 August 2011, in force 15 February 2013) does not apply to medical devices: Article 1(2) excludes «изделия медицинского назначения» from the regulation's scope outright. A medical electrical device therefore carries no separate EAEU low-voltage certificate. Electrical safety is examined as part of the device's own registration and import-conformity files, not as a standalone pre-market approval.
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 Armenia routes to check
Import CoC / PVoC
Medical-device import (conformity) certificate
Handled as an import or shipment-level obligation.
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
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 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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