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 Radiation-protection authorisation for the use of X-ray diagnostic equipment in Georgia?
Describe your device to check whether Radiation-protection authorisation for the use of X-ray diagnostic 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 Radiation-protection authorisation for the use of X-ray diagnostic 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.
The Law of Georgia on Radiation Protection, Nuclear Safety and Security (No 3284-XIმს-Xმპ of 16 June 2023) makes the Nuclear and Radiation Safety Agency within the Ministry system the regulatory body (Article 10(1)) and forbids carrying out nuclear and radiation activity without the authorisation — registration, licence and/or permit — issued by it (Article 16(2)). Article 19(1) subjects to registration, among other activities, the use of dental and intraoral X-ray diagnostic devices, the use of osteodensitometry X-ray diagnostic devices, the use of devices that generate secondary X-rays, and trade in ionizing-radiation sources; Articles 20 and 22 provide the licence and permit routes. The radiation-safety technical regulation approved by Government Decree No. 77 of 17 March 2025 (in force 1 June 2025; its text is an attachment to the decree) then sets the operating duties of the authorised person. The duty falls on whoever operates the equipment, 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.
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
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
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.
Parliament of Georgia
Law of Georgia No 3284-XIმს-Xმპ of 16 June 2023 on Radiation Protection, Nuclear Safety and Security — Article 10(1), 16(2), 19(1)
Government of Georgia
Government Decree No. 77 of 17 March 2025 — radiation-safety technical regulation, in force 1 June 2025 (reg. code 300160070.10.003.024968)
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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