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 Legal metrology type approval and verification — closed list without healthcare instruments in Georgia?
Describe your device to check whether Legal metrology type approval and verification — closed list without healthcare instruments may apply, why, what facts are missing, and which official source to review.
1 maintained routes3 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 Legal metrology type approval and verification — closed list without healthcare instruments check is screening
Checks whether a clinical measuring function needs model approval or initial/periodic verification. 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
- Legal metrology
- Regulatory object
- measuring instrument
- Maintained rule status
- evidence only no separate certificate
- Useful product facts
- Measured quantity, clinical decision use, units, accuracy claim, and whether the value drives treatment.
Type approval and verification do exist in Georgia: the Product Safety and Free Movement Code Article 80(1) defines legalised measurement means, and Government Decree No. 369 of 24 December 2013 provides for entry of a type approval or recognition in the state registry and for verification. But Article 80(2) of the Code fixes a closed list of legalised measurement means — those used for the purposes of the Tax Code, the Customs Code or forensic examination, and those whose results impose an administrative fine — and healthcare instruments are not on it. Government Decree No. 480 of 31 December 2024, which transposes the measuring-instruments regime and enters into force on 1 December 2028, is likewise confined to water, gas, electricity and thermal meters, non-water liquid flow, automatic weighing, level gauges and exhaust analysers. No metrology requirement applicable to a medical device was evidenced; the 1996 law on ensuring the uniformity of measurements was repealed on 25 May 2012 and must not be cited.
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
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.
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)
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?
Keep researching this market
More Georgia medical device resources
Continue with this market