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Georgia medical device certification and licence checker

Check Georgia requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.

8 maintained routes15 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.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

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 Georgia

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

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

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.

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices (reg. code 470000000.10.003.024219)

Parliament of Georgia

Law of Georgia on Medicines and Pharmaceutical Activities — state registration regimes, clocks and validity

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

Government of Georgia

Government Decree No. 161 of 24 April 2023 — radio equipment technical regulation (electrical safety, EMC and spectrum)

Government of Georgia

Government Decree No. 165 of 1 May 2023 — low-voltage electrical equipment technical regulation, Annex II(1)(ბ) medical-purpose exclusion (TR registry No. 305 of 02.05.2023)

Parliament of Georgia

Code of Georgia on Product Safety and Free Movement — Articles 56, 57, 58, 61 and Article 80 legalised measurement means

Government of Georgia

Government Decree No. 369 of 24 December 2013 — type approval and verification of measuring instruments

Government of Georgia

Government Decree No. 480 of 31 December 2024 — measuring instruments regime in force 1 December 2028 (meters, flow, weighing, level gauges, exhaust analysers)

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)

Government of Georgia

Government Decree No. 326 of 2020 — technical regulation on waste electrical and electronic equipment, producer registration and individual compliance schemes

Government of Georgia

Government Decree No. 324 of 2020 — producer responsibility for batteries and accumulators

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Government Decree No. 586 of 2 December 2019 — RAMA services, fee amounts, payment, refund and exemption rules

Government of Georgia

Government Decree No. 384 of 3 October 2023 — amending Decree No. 586, adding the medical-device clinical-investigation fees

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.