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Regulation Agency for Medical and Pharmaceutical Activities (RAMA) Β· Europe

Georgia medical device regulatory resources

Every Georgia dataset, comparison, and AI workpaper we maintain β€” one entry point for the whole market.

5 free resources24/25 topics with records6 regulations trackedSep 2026 fees reviewed
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AI medical device classifier

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Additional certification and licence checker

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Government registration fees

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Registration timeline

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Medical device regulations

Browse Georgia's official medical-device instruments β€” government decrees, ministerial orders and the medicines and product-safety laws β€” with citeable Georgian and English passages.

Structured regulatory requirements

Explore all 31 source-linked facts β†’

24 of 25 research dimensions currently covered Β· 18 official sources Β· latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
Competent authority β€” LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA), under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs
The medical device authority in Georgia is the LEPL Regulation Agency for Medical and Pharmaceutical Activities (αƒ‘αƒαƒ›αƒ”αƒ“αƒ˜αƒͺαƒ˜αƒœαƒ და Ⴠარმაαƒͺαƒ”αƒ•αƒ’αƒ£αƒšαƒ˜ ბაαƒ₯αƒ›αƒ˜αƒαƒœαƒαƒ‘αƒ˜αƒ‘ αƒ αƒ”αƒ’αƒ£αƒšαƒ˜αƒ αƒ”αƒ‘αƒ˜αƒ‘ αƒ‘αƒαƒαƒ’αƒ”αƒœαƒ’αƒ), a public law l…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Binding product requirements in Georgia take the form of technical regulations adopted under law or by Government ordinance, and Georgia recognises EU technical regulations
In Georgia the binding form of a product requirement is the technical regulation. Any binding act containing technical standards must be adopted in the form of a technical regulation; techn…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Verified
Device definition β€” instruments, apparatus, appliances, software, implants, reagents and materials for stated medical purposes, including in-vitro examination of human samples
The device clinical investigation technical regulation defines a medical device as any instrument, apparatus, appliance, computer program (software), implant, reagent, material or other pro…
'Medical goods' are a separate statutory category from 'pharmaceutical product' β€” and non-invasive contraceptive mechanical devices are exempt outright
Georgian law defines 'medical goods' β€” medical goods used in medical practice for disease prevention, diagnostics, treatment and patient care such as instruments, devices, appliances, medic…
2 source-linked facts
Checked 2026-09-16
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D04

Classification rules

Verified
Georgian classes I, IIa, IIb and III
Class I β€” low risk, Class IIa β€” medium risk, Class IIb β€” increased risk, Class III β€” high risk
1 maintained scheme Β· 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
Two registration regimes β€” recognition and national β€” for the categories registered under the Law on Medicines
Where a Georgian marketing authorisation is required, the Law on Medicines provides exactly two regimes: the recognition regime of state registration and the national regime of state regist…
1 source-linked fact
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Dental material, invasive contraceptive mechanical devices and diagnostic products: an ISO certificate, an EC certificate or a free sale certificate stands in for the CPP
statement: For the three device type categories that are registered under the Law on Medicines β€” dental material, invasive mechanical means of contraception, and means of diagnostics (test…
Recognised-country exemption for a next-generation device clinical investigation
statement: Under the medical device clinical investigation technical regulation, the requirement that a first time international clinical investigation on humans take place in a country rec…
3 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Who may apply β€” 'interested person' for registration; sponsor's in-country representative or a Georgian CRO for a clinical investigation
For state registration the applicant is an 'interested person': a manufacturer, a trade licence holder, an importer or any other natural or legal person interested in the marketing authoris…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Administrative fines for placing or making available a non-compliant product on the Georgian market
Placing on the market, or making available on the market, a product that does not comply with the requirements established for it by Georgian legislation and that does not pose a threat to…
Duties of an economic operator for a product placed on the Georgian market
An economic operator β€” a manufacturer, authorised representative, importer, distributor or the person supplying the product directly to the user, as defined by Article 4 of the Code β€” must…
4 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Clinical-investigation registration dossier β€” application and fee receipt, notarised mandate, protocol, insurance, ethics opinion, investigator documentation
To register a medical device clinical investigation the applicant files with the Agency: an application in the form set by the Agency together with a receipt for the registration fee; the o…
Dossier for the three device-type categories β€” a short, category-specific list
For a contraceptive mechanical device (other than a non invasive one) the scientific and technical part of the dossier is: the name and address of the manufacturer; a standard determining t…
2 source-linked facts
Checked 2026-09-16
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D10

Official forms & portals

Verified
The Departmental Registry is a public electronic document accessible via the internet; application forms are set by the Agency
Entry of a product into the Departmental Registry means that marketing authorisation in Georgia has been granted. The Registry records a registration number, the interested person, the manu…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Georgian-language patient information leaflet and a standard packaging/labelling sample
The administrative part of the registration dossier must include a standard packaging with standard labelling (or an electronic version) of the product to be registered, and, for an importe…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Inspection of a device clinical investigation, and evidence of manufacture to the relevant standard
The device clinical investigation technical regulation makes an inspection of the clinical investigation a ground on which the Agency revokes its consent to that investigation: the Agency r…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
Radio equipment and telecommunications terminal equipment certification
Wireless / radio
Radio-frequency spectrum use authorisation
Wireless / radio
Electromagnetic compatibility essential requirements for radio equipment
EMC
8 maintained overlays Β· 1 related fact
Checked 2026-09-16
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D14

Fees

Verified
Medical-device clinical-investigation application review fee β€” Class I
GEL 10,000
Medical-device clinical-investigation application review fee β€” Classes IIa, IIb and III
GEL 30,000
5 maintained fee lines
Checked 2026-09-16
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D15

Review clocks

Verified
Class I β€” clinical-investigation registration Β· Application to the Agency; registration certificate issued by decision of the Agency
20 working days
Classes IIa, IIb and III β€” clinical-investigation registration on a Council recommendation Β· Application to the Agency; registration only on the positive recommendation of the Coordination Council for clinical investigations of medical devices
20 working days
Any class β€” primary state registration under the Law on Medicines (national regime) Β· National regime of state registration, for the device-type categories the Law on Medicines registers: dental material, invasive mechanical means of contraception, and means of diagnostics
3 months
4 maintained pathways Β· 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Five-year circulation period; re-registration documents due two months before expiry; recognition-regime validity capped at five years
Circulation of a registered product on Georgian territory is permissible for 5 years after registration, and after expiry of the registration validity period until expiry of the shelf life…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Variations are registered as Type IA, Type IB and Type II, with their own clocks and no extension of the validity period
Changes to a registered product are made by registering a variation. Type I variations are those 'of less significant importance' and are split into Type IA and Type IB; Type II variations…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Economic-operator identity marking, technical-document retention and supply-chain information for a product on the Georgian market
Georgia's product traceability layer runs through the economic operator. An economic operator must indicate its own name, registered trade name or registered trademark, and contact informat…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Device clinical investigations are registered with the Agency; class IIa/IIb/III need a positive Coordination Council recommendation
Clinical investigations of medical devices are conducted under the technical regulation approved by Government Decree No. 386 of 3 October 2023 and must be registered with the Agency. For c…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Exemptions from registration β€” non-invasive contraceptive mechanical devices and certain pharmaceutical forms; voluntary registration for complementary products
Non invasive contraceptive mechanical devices are exempt from the state regulation provided for by the Law on Medicines. Pharmaceutical substances, bulk and intermediary products, products…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
The manufacturer's post-market duties in Georgia: warning end users, analysing risks and taking preventive measures including recall
Under the Code of Georgia on Product Safety and Free Movement a manufacturer must, within the scope of its competence, warn end users of any visible or invisible risks contained in a produc…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
SUSAR reporting within 7 / 15 calendar days and an annual safety report during a device clinical investigation
The holder of a medical device clinical investigation registration certificate must submit to the Agency information on suspected unexpected serious adverse reactions (SUSARs) arising in th…
1 source-linked fact
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Circulating a product outside the registration regimes β€” GEL 6,000 fine and seizure of the goods, GEL 12,000 if repeated
Circulation of a product circumventing the regimes for granting a Georgian marketing authorisation, and/or circulation of a product that has not been granted a marketing authorisation in Ge…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Medical devices are advertising goods under Georgia's general Law on Advertising; there is no device-specific advertising regime
Georgia's advertising regime is the general Law of Georgia on Advertising. The Law governs legal relations arising in the course of the production, placement and dissemination of advertisem…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Deemed registration if the Agency does not notify a refusal in time; refusal must be reasoned and in writing
If the Agency refuses to register a product it must immediately give the interested person written notice of a reasoned refusal. If the interested person is not notified of a decision not t…
1 source-linked fact
Checked 2026-09-16
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Government fees

Full fee schedule (5 lines) β†’

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) registration fees in GEL Β· reviewed 2026-09-16

Fee lineAmountProvenance
Medical-device clinical-investigation application review fee β€” Class IGEL 10,000Verified
Medical-device clinical-investigation application review fee β€” Classes IIa, IIb and IIIGEL 30,000Verified
Extension of the validity of a Class I medical-device clinical-investigation certificateGEL 5,000Verified
Extension of the validity of a Classes IIa, IIb and III medical-device clinical-investigation certificateGEL 15,000Verified
1 more fee lines on the full schedule Β· 5 of 5 rows source-verified

Registration timeline

Full registration timeline β†’

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) (Regulation Agency for Medical and Pharmaceutical Activities (RAMA)) review clocks and planning ranges Β· Four-class axis (I, IIa, IIb, III) set by Annex No. 1.1 to the medical-device clinical-investigation technical regulation, Government Decree No. 386 of 3 October 2023 classification

Class / pathwayReview clockPlanning totalProvenance
Class I β€” clinical-investigation registration(Application to the Agency; registration certificate issued by decision of the Agency)20 working days2-4 monthsVerified
Classes IIa, IIb and III β€” clinical-investigation registration on a Council recommendation(Application to the Agency; registration only on the positive recommendation of the Coordination Council for clinical investigations of medical devices)20 working days4-8 monthsVerified
Any class β€” primary state registration under the Law on Medicines (national regime)(National regime of state registration, for the device-type categories the Law on Medicines registers: dental material, invasive mechanical means of contraception, and means of diagnostics)3 months5-9 monthsVerified
Any class β€” re-registration and registration-and-recording under the Law on Medicines(National regime of state registration, re-registration after expiry of the five-year validity period)2 months4-7 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(20 working days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 6 Georgia regulations β†’

Official Regulation Agency for Medical and Pharmaceutical Activities (RAMA) rules and guidance Β· 6 of 6 documents linked to official sources

Government Decree No. 334 of 7 October 2024Amendment to Decree No. 386 β€” Clinical Investigation of Registered-Device Analogues
Clinical TrialsVerified
Government Decree No. 386 of 3 October 2023Technical Regulation on Clinical Investigation of Medical Devices
Clinical TrialsVerified
Document No. 659, 17/04/1997Law of Georgia on Medicines and Pharmaceutical Activities
GeneralVerified
Order No. 01-34/αƒœ of 12 June 2012Repeal of Certain Normative Acts of the Minister of Labour, Health and Social Affairs
GeneralVerified
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