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 Radio equipment and telecommunications terminal equipment certification in Georgia?
Describe your device to check whether Radio equipment and telecommunications terminal equipment certification 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 Radio equipment and telecommunications terminal equipment certification check is screening
Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Maintained as a mandatory pre-market route.
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
- Radio and spectrum approval
- Regulatory object
- radio equipment
- Maintained rule status
- mandatory pre market
- Useful product facts
- Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.
Article 58(2) of the Law of Georgia on Electronic Communications requires radio installations and telecommunications terminal equipment to comply with the essential requirements laid down by the certification regulation, and Article 59(1)-(2) requires certification by accredited centres and laboratories under a regulation approved by the Commission. The regulation is the Georgian National Communications Commission's Decree No. 2 of 24 December 2004, whose Article 16(1)(ბ) requires the CE or GES conformity marking and Article 16(3) the responsible body's identification number; Annex 1 of the same decree carries the electromagnetic-compatibility essential requirements. Certification is a condition of placing the equipment on the market, and breach is sanctioned under Article 171(4) of the Code of Administrative Offences.
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-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
Electrical safety
Low-voltage equipment technical regulation — medical electrical equipment excluded
Evidence may be required, but the matrix does not identify a generic separate certificate.
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.
Georgian National Communications Commission (ComCom)
Law of Georgia on Electronic Communications — Article 43(4) spectrum use, Article 58(2) and 59 certification of radio equipment
Georgian National Communications Commission (ComCom)
GNCC Decree No. 2 of 24 December 2004 — certification regulation, Annex 1 electromagnetic-compatibility essential requirements
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
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