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 Low-voltage equipment technical regulation — medical electrical equipment excluded in Georgia?
Describe your device to check whether Low-voltage equipment technical regulation — medical electrical equipment 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 Low-voltage equipment technical regulation — medical electrical equipment 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.
Georgia does have a low-voltage technical regulation — Government Decree No. 165 of 1 May 2023, registered in the Technical Regulations Registry as No. 305 of 2 May 2023 — which applies to electrical equipment designed for use between 50 and 1000 volts alternating current and 75 and 1500 volts direct current (Article 1(2)). Annex II(1)(ბ) excludes electrical equipment intended for radiological and medical purposes from its scope, so a medical electrical device carries no Georgian low-voltage conformity certificate. The regulation's own conformity route is internal production control (Annex III Module A) with a declaration of conformity under Article 12.
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 Georgia routes to check
Wireless / radio
Radio equipment and telecommunications terminal equipment certification
Maintained as a mandatory pre-market route.
Source association reviewed
Wireless / radio
Radio-frequency spectrum use authorisation
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
EMC
Electromagnetic compatibility essential requirements for radio equipment
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Metrology
Legal metrology type approval and verification — closed list without healthcare instruments
Evidence may be required, but the matrix does not identify a generic separate certificate.
Source association reviewed
Radiation
Radiation-protection authorisation for the use of X-ray diagnostic equipment
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Environmental / battery
Waste electrical and electronic equipment producer responsibility — importer registration
Maintained as a mandatory pre-market route.
Source association reviewed
Adapters / components
Technical regulations as the only binding product requirement, with EU technical regulations recognised
Evidence may be required, but the matrix does not identify a generic separate certificate.
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 Georgia 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 Georgia?
- 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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