Regulation Agency for Medical and Pharmaceutical Activities (RAMA) · structured requirements

🇬🇪 Georgia medical device regulatory data

Explore the medical device requirements currently available for Georgia, organized by topic and linked to official sources.

31 facts24 dimensions7 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Medical devices are advertising goods under Georgia's general Law on Advertising; there is no device-specific advertising regime

advertising.general-law-on-advertising-covers-goods-without-a-device-specific-regime

Fact-level verified

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 advertisements of commodities (works, services) and of the financial market of Georgia, and an 'advertisement' is information about goods, services and works disseminated by any means and in any form that is intended for an unlimited group of persons and serves to form and maintain interest in goods and to facilitate their sale. 'Improper advertising' is unfair, unreliable, unethical, misleading or other advertising that violates the requirements for content, timing, placement and dissemination established by the legislation of Georgia; 'unreliable advertising' is advertising containing untrue data about the qualities of goods, their ingredients, the place, way and date of production, the purpose, consumer properties, conditions for use, certification marks or compliance with state standards, quantity, availability of products on the market, price, warranty obligations, the results of a product investigation and tests, and the actual demand for the product. The placement and dissemination of improper advertisements is prohibited and entails liability under Georgian legislation; liability falls on the advertising customer, producer and disseminator, and a person whose rights and interests are infringed by improper advertising may claim damages in court and require public refutation of the improper advertising. The Law's special advertising regimes are reserved to named product classes — pharmaceutical products, artificial baby food, weapons, securities, sex-related products, tobacco, alcohol and human organ/tissue/cell matters — and medical devices are not among them, so a device is advertised as an ordinary commodity under the general rules. Two general provisions bite directly on a device: advertising goods whose production and sale is prohibited by Georgian legislation, or which require a special permit (licence) not yet obtained, is inadmissible, as is advertising an economic agent whose activity requires a special permit (licence) not yet obtained; and advertising of goods that require a special certificate must be marked with the word 'certified'.

Conditions

There is no device-specific advertising instrument in Georgia. The Law on Advertising's health-products chapter (Art. 9) is addressed to pharmaceutical products only; 'medical goods' (instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products) are a category distinct from 'pharmaceutical product' under the Law on Medicines, Art. 1(12).
Art. 4(6) bites on a device only through the special permit/licence limb: in Georgia the device-type categories that require a state registration decision are dental material, invasive mechanical means of contraception and means of diagnostics, and those require a marketing authorisation rather than a 'special permit (licence)' in the sense of the Law on Advertising. The provision is quoted as the Law's own rule; it is not asserted here that a general medical device needs a permit before it may be advertised.
Art. 2(8) lists what this Law regulates specially (broadcast advertising, alcoholic beverages, sex-related items, tobacco, human organs/tissues/cells and medical institutions carrying out transplantation and health care personnel, games of chance, pharmaceutical products, artificial baby food, weapons, securities, minors' protection). Medical devices and medical equipment are not named.
Art. 2(1) confines the Law to advertisements of commodity and financial markets; the language requirement for advertisements (Art. 4(2), official language throughout Georgia) is a general advertising requirement and not a device labelling rule — the device labelling rule is in the label dimension and rests on the Law on Medicines.
Art. 21(1) provides liability for advertising customers, producers and disseminators under Georgian legislation; the Law does not itself fix a device-specific penalty.

Language of source: English consolidated text on matsne.gov.ge. Verbatim: Art. 2(1) "This Law shall govern legal relations originated in the course of production, placement and dissemination of advertisements of commodity (works, services) and financial markets (including the securities market) of Georgia." Art. 3(2) "Improper advertising – unfair, unreliable, unethical, misleading or other advertisement that violates the requirements for content, timing, placement and dissemination established by the legislation of Georgia;" Art. 3(4) "Unreliable advertising – advertisement that contains untrue data about an advertising customer, qualities of goods, ingredients, also the place, way and date of production, the purpose, consumer properties, conditions for use, certification marks, compliance with state standards, quantity, availability of products on the market, the possibility of purchasing the stated amount at a specific place and within a specific period of time; and the cost (price) of the product at the time of advertising, additional terms of payment, delivery, return, repair, warranty obligations, and the best before period, the right to use state symbols … official recognition (commendations, prizes, diplomas, and other awards), the results of a product investigation and tests, and the actual demand for the product;" Art. 4(6) "Advertising of goods the production and sales of which is prohibited by the legislation of Georgia or which requires a special permit (licence) but not obtained yet; also advertising of an economic agent whose activities require a special permit (licence) but not obtained yet, shall be inadmissible." Art. 4(7) "Advertising of goods that requires a special certificate must be marked with the word 'certified'." Art. 4(8) "Placement and dissemination of improper advertisements shall be prohibited. They shall entail liability under the legislation of Georgia that is commensurate with the action committed, the degree of public hazard and its nature." Art. 21(1) "Natural and legal persons (advertising customers, producers and disseminators) shall be held liable for violating the advertising legislation of Georgia under the legislation of Georgia." Art. 21(3) "Persons whose rights and interests are infringed by improper advertising may make a claim in court, in a prescribed manner, for compensation of damage to their health and property, name, dignity and business reputation, and require public refutation of improper advertising." ADJUDICATION OF THE CONTRADICTION WITH regulatory-fact:georgia:advertising-claims-promotion:advertising-rules-attach-to-registered-products: that earlier row stated that no medical-device advertising regime was found and applied the Law on Medicines advertising chapter to the registered device-type categories. Both halves are now resolved. (1) No device-specific regime exists — that part is confirmed, and Art. 9 of the Law on Advertising (Advertising of pharmaceutical products) was read in full: it is pharmaceutical-only and does not reach devices. (2) A general advertising regime that reaches devices does exist, and the earlier row did not cite it: the Law on Advertising governs advertisements of commodities generally, its prohibited-claims provisions are framed on 'goods', and medical devices are not named in any of its special regimes. The earlier row is therefore not repealed but is incomplete on the operative prohibition; this row is written under a new key so that the importer does not overwrite that row's pharmaceutical finding, and the two are to be read together.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Five-year circulation period; re-registration documents due two months before expiry; recognition-regime validity capped at five years

validity.five-year-circulation-and-re-registration-window

Fact-level verified

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 of the product. For re-registration, registration documents must be submitted not later than two months before expiry of the registration validity period; otherwise the product is registered under the primary registration regime. Where the product was registered through the recognition regime, the Georgian authorisation period follows the foreign authorisation period but is not more than 5 years.

Conditions

On re-registration the applicant must file the Art. 11^11(19) documents plus at least 4 years of side-effect data from the 5-year authorisation period, publications and bibliography, the current specification and analytical methods, and a fee-payment document (Art. 11^11(7)).
Expiry of the registration validity period revokes the marketing-authorisation document (Art. 11^11(15)).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^11(16): "Circulation of a pharmaceutical product in the territory of Georgia shall be permissible during 5 years after its registration, and after expiry of the registration validity period – until expiry of the shelf life of the pharmaceutical product..." Art. 11^11(6): "For the re-registration of a pharmaceutical product, registration documents shall be submitted not later than two months prior to expiry of the registration validity period. Otherwise, a pharmaceutical product shall be registered under the primary registration regime."

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority — 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

authority.regulation-agency-for-medical-and-pharmaceutical-activities

Fact-level verified

The medical-device authority in Georgia is the LEPL Regulation Agency for Medical and Pharmaceutical Activities (სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო), a public-law legal entity under the state control of the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs. Under the medical-device technical regulation the Agency registers clinical investigations of medical devices, issues the clinical-investigation registration certificate and takes the connected decisions; under the Law on Medicines the Agency grants, refuses, suspends and revokes marketing authorisations, formalises the marketing-authorisation document and keeps the Departmental Registry.

Conditions

The Ministry is 'საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო' (Decree No. 386 of 3 October 2023, Art. 2(ძ)).
The Agency's public website (rama.moh.gov.ge) returns HTTP 403 to every retrieval method available in this session; the authority identity is therefore evidenced from the primary instruments on matsne.gov.ge rather than from the Agency's own site.

Language: Georgian. Verbatim, Decree No. 386 of 3 October 2023, Art. 2: "ძ) სამინისტრო − საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო;" and "წ) სააგენტო − სამინისტროს სახელმწიფო კონტროლს დაქვემდებარებული საჯარო სამართლის იურიდიული პირი – სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო."

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Variations are registered as Type IA, Type IB and Type II, with their own clocks and no extension of the validity period

change.variations-type-ia-ib-and-ii

Fact-level verified

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 are the remainder. A variation is decided within 20 calendar days (Type IA) or 40 calendar days (Type IB); a Type-II variation follows the 3-month primary-registration clock. Registration of a variation does not change the registration validity period, and a product available before a variation may be circulated in Georgia until expiry of its shelf life.

Conditions

For Type-IA variations to the manufacturing licence a renewed manufacturing licence must be submitted; for a change of product name the new name must not cause confusion with an international off-patent name or a registered product name.
Where part of the registration documents changes without being registered or entered in the register under the established procedure, the Agency temporarily suspends the registration until the cause is removed (Art. 11^11(13)(b)).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^11(21) opening: "Type I variations (of less significant importance):" and Art. 11^11(21)(i): "for the registration of contraceptive mechanical devices (except for non-invasive contraceptive mechanical devices):". Art. 11^11(5)(b): "the registration of a variation shall not entail change of the registration validity period." Art. 11^11(17): "In case of variations, a pharmaceutical product available prior to variations introduced may be circulated on the territory of Georgia up to expiry of its shelf life."

Classification rules

What local class follows from which rules and decisive product facts?

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Four risk classes (I, IIa, IIb, III) with EU-style classification rules in Annex No. 1.1 to the device technical regulation

classification.risk-classes-i-iia-iib-iii

Fact-level verified

Medical devices are classified into classes I, IIa, IIb and III under Annex No. 1.1 to the device clinical-investigation technical regulation, which reproduces the EU-style rule set: active devices for administering or removing medicinal products, body liquids or other substances are IIa (IIb where the method is potentially hazardous); active devices for diagnostic or therapeutic radiology, including interventional radiology devices, are IIb; software providing information for diagnostic or therapeutic decisions is IIa, rising to IIb or III on the severity of the decision; devices for contraception or prevention of sexually transmitted disease are IIb, or III if implantable or long-term invasive; devices incorporating a substance that would itself be a pharmaceutical product are III; devices of human or animal tissue origin are III; nanomaterial devices are III, IIb or IIa according to internal-exposure potential. Clinical investigation of class IIa, IIb and III devices is registered only on a positive recommendation of the Coordination Council for Clinical Investigations of Medical Devices.

Conditions

The classification rules are in an annex to the clinical-investigation technical regulation; registration under the Law on Medicines for the three device-type categories does not itself turn on these classes.
The class of the device determines the clinical-investigation registration route (Coordination Council recommendation for IIa/IIb/III).

Language: Georgian. Verbatim, Annex No. 1.1, Art. 7(2): "ყველა მოწყობილობა, რომელიც გამოიყენება კონტრაცეფციისთვის ან სქესობრივი გზით გადამდები დაავადებების პრევენციისთვის, კლასიფიცირდება როგორც IIb კლასი, გარდა იმ შემთხვევისა, როდესაც ეს არის იმპლანტირებული ან გრძელვადიანი ინვაზიური მოწყობილობა, ამ შემთხვევაში ისინი კლასიფიცირდება როგორც III კლასი." Art. 6(6): "აქტიური მოწყობილობები, რომლებიც განკუთვნილია მაიონიზებელი გამოსხივებისთვის და ემსახურება დიაგნოსტიკური ან თერაპიული რადიოლოგიის მიზნებს, მათ შორის, ინტერვენციული რადიოლოგიის მოწყობილობები ... კლასიფიცირდება როგორც IIb კლასი." Class-based clinical-investigation registration: Art. 3(5).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Device clinical investigations are registered with the Agency; class IIa/IIb/III need a positive Coordination Council recommendation

clinical-investigation.registration-and-council-recommendation

Fact-level verified

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 class IIa, IIb and III devices the Agency registers the investigation only on the basis of a positive recommendation of the Coordination Council for Clinical Investigations of Medical Devices; for all other classes the registration certificate is issued by Agency decision. A clinical investigation is conducted for all medical devices and active implantable medical devices, and for class III devices based on technology not previously used or used only rarely, or where the scope of use of the device is being extended. Where available clinical data from the clinical evaluation are insufficient to confirm efficacy and safety, the manufacturer must also carry out a clinical investigation.

Conditions

A clinical investigation involving medical devices may not be carried out on a foreign national (Art. 6(5) of the technical regulation).
Healthy volunteers may take part only in clinical investigations of non-invasive (class I) devices (Art. 6(4)).
The investigation must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020 (Art. 3(2)).

Language: Georgian. Verbatim Art. 3(5): "IIa, IIb და III კლასის სამედიცინო მოწყობილობებზე კლინიკური კვლევის რეგისტრაციას სააგენტო ახორციელებს მხოლოდ სამედიცინო მოწყობილობებზე კლინიკური კვლევების საკოორდინაციო საბჭოს დადებითი რეკომენდაციის საფუძველზე. ამ დადგენილებით განსაზღვრული ყველა სხვა კლასის სამედიცინო მოწყობილობებზე რეგისტრაციის მოწმობა გაიცემა სააგენტოს გადაწყვეტილებით." Art. 3(3): "კლინიკური კვლევა ტარდება ყველა სამედიცინო მოწყობილობისა და აქტიური იმპლანტირებადი სამედიცინო მოწყობილობისთვის, ასევე − III კლასის სამედიცინო მოწყობილობებისთვის, რომელთა ექსპლუატაცია ეფუძნება ტექნოლოგიებს, რომლებიც ადრე არ იყო გამოყენებული ან ნაკლებად გამოიყენებოდა, ან მათთვის, ვინც აფართოებს სამედიცინო მოწყობილობის გამოყენების ფარგლებს."

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition — instruments, apparatus, appliances, software, implants, reagents and materials for stated medical purposes, including in-vitro examination of human samples

scope.medical-device-definition

Fact-level verified

The device clinical-investigation technical regulation defines a medical device as any instrument, apparatus, appliance, computer program (software), implant, reagent, material or other product intended by the manufacturer for human use, alone or in combination, for one or more of: (a) diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation or compensation of injury or disability; (c) investigation, replacement or modification of anatomical, physiological or pathological processes or states; (d) provision of information by in-vitro examination of samples derived from the human body, including organ, blood and tissue donation, whose principal intended action is not achieved by pharmacological, immunological or metabolic means but which may assist such means; (e) devices for contraception or its promotion; (f) products specifically intended for cleaning, disinfecting or sterilising devices.

Conditions

This definition sits in the annex to a technical regulation on clinical investigation; there is no separate Georgian medical-device law, so it is the only statutory device definition found in force.
Sub-paragraph (d) brings in-vitro diagnostic products within the device definition.
The Law on Medicines uses a different term for the wider product group — 'medical goods' (Art. 1^1(12)) — covering instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products.

Language: Georgian. Verbatim: "დ) სამედიცინო მოწყობილობა − ნებისმიერი ინსტრუმენტი, აპარატი, ხელსაწყო, კომპიუტერული პროგრამა (სოფტი), იმპლანტი, რეაგენტი, მასალა ან სხვა პროდუქტი, რომელიც მწარმოებლის მიერ განკუთვნილია ადამიანებისთვის, ცალკე ან კომბინაციით, შემდეგი კონკრეტული სამედიცინო მიზნებიდან ერთისთვის ან მეტისთვის: დ.დ) ინფორმაციის მიწოდება ადამიანის ორგანიზმიდან მიღებული ნიმუშების ინ ვიტრო კვლევის გზით ... დ.ე) მოწყობილობები ჩასახვის კონტროლისთვის ან ხელშეწყობისთვის; დ.ვ) პროდუქტები, რომლებიც სპეციალურად არის განკუთვნილი მოწყობილობების გაწმენდისთვის, დეზინფექციისთვის ან სტერილიზაციისთვის;"

'Medical goods' are a separate statutory category from 'pharmaceutical product' — and non-invasive contraceptive mechanical devices are exempt outright

scope.medical-goods-defined-separately-from-pharmaceutical-product

Fact-level verified

Georgian law defines 'medical goods' — medical goods used in medical practice for disease prevention, diagnostics, treatment and patient care such as instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products — as a category distinct from 'pharmaceutical product', which is a medicine or physiologically active substance whose effect on the human body results from pharmacological, immunological or metabolic action. The state-regulation mechanisms of the Law on Medicines are attached to pharmaceutical products and to voluntarily registered complementary products; non-invasive contraceptive mechanical devices are expressly exempt from the state regulation provided for by that Law.

Conditions

The exemption in Art. 1(4) covers non-invasive contraceptive mechanical devices only; invasive contraceptive mechanical devices remain subject to registration.
This is the scope article that confines the Law's registration regimes, and it is the basis for the finding that general medical goods (instruments, devices, equipment) are outside them.

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 1^1(12): "Medical goods – medical goods used in medical practice for disease prevention, diagnostics, treatment, and patient care such as instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products, etc." Art. 1^1(13): "Pharmaceutical product (therapeutic agent) – a medicine or a physiologically active substance derived naturally or by synthesis or a combination thereof, the effect of which on a human body is a result of the pharmacological, immunological or metabolic action, and which is allowed for medical use..." Art. 1(4): "Non-invasive contraceptive mechanical devices shall be exempt from the state regulation provided for by this Law."

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Clinical-investigation registration dossier — application and fee receipt, notarised mandate, protocol, insurance, ethics opinion, investigator documentation

dossier.clinical-investigation-application

Fact-level verified

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 original, apostilled/legalised and notarised document delegating the sponsor's authority, with a notarised Georgian translation; the clinical investigation plan and protocol drawn up to GCP standards with a notarised Georgian translation; the subject information sheet and written informed-consent form with a notarised Georgian translation; the case report form in English in electronic form; the original risk/responsibility insurance document signed by the sponsor or its authorised person and by an insurance company registered in Georgia; evidence of manufacture to the relevant standard; written consents of the directors and clinical managers of the participating medical institutions; reasoned positive opinions of each institution's local independent ethics committee; and the investigator's CV, licence certificates, GCP training certificate and investigator's brochure.

Conditions

Documentation must be in Georgian or carry a notarised Georgian translation; the case report form is filed in English.
The application form is set by the Agency, not by the decree.

Language: Georgian. Verbatim, Art. 7(1)(ა): "აპლიკაცია, სააგენტოს მიერ დადგენილი ფორმით და რეგისტრაციისათვის დადგენილი საფასურის გადახდის ქვითარი;" Art. 7(1)(ბ): "სპონსორის მიერ მაძიებელზე გაცემული წარმომადგენლობითი უფლებამოსილების დელეგირების/მინდობილობის მინიჭების დამადასტურებელი დოკუმენტის ორიგინალი ... აპოსტილირებული/ლეგალიზებული და ნოტარიულად დამოწმებული უცხო ქვეყნის მიერ (ნოტარიულად დამოწმებული ქართულენოვანი თარგმანით);"

Dossier for the three device-type categories — a short, category-specific list

dossier.device-category-documents

Fact-level verified

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 the quality criteria; and 2 samples accompanied by a certificate of quality. For a dental product: name, composition, component data and designation; a standard determining the quality criteria; a certificate of quality; safety data; and a sample. For diagnostic products — test systems (by nosology), allergens (other than allergens designated for an individual natural person), reagents for clinical biochemistry and chemistry, and sera: designation and method of use, a list with the manufacturing company's catalogue number and/or catalogue; safety and efficacy data for in vivo use; and quality-assessment criteria plus stability data if necessary.

Conditions

These documents sit in the scientific and technical part of registration documents (Art. 11^11(20)(i)–(k)); the administrative part of Art. 11^11(19) (application, CPP or ISO/EC/free-sale certificate, packaging and labelling sample, Georgian-language patient information leaflet, fee receipt) applies in addition.
The list is markedly shorter than the pharmaceutical dossier in Art. 11^11(20)(a)–(b), which is the practical difference for an exporter.

Language of source: English consolidated text on matsne.gov.ge. Verbatim: "i) for the registration of contraceptive mechanical devices (except for non-invasive contraceptive mechanical devices): i.a) the name and address of a manufacturer of a contraceptive device; i.b) a standard determining the quality criteria; i.c) 2 samples of a contraceptive device, accompanied with a respective certificate of quality; j) for the registration and recording of a dental product: j.a) the name, composition, data on the components and designation of a dental product; j.b) a standard determining the quality criteria; j.c) a certificate of quality of the dental product; j.d) data on the safety of the dental product; j.e) a sample of the dental product; k) for the registration and recording of diagnostic products – test systems (according to nosologies), allergens (except for allergens designated for an individual natural person), reagents (for clinical biochemistry and chemistry), and sera: k.a) designation and method of use of diagnostic products (a list with an indication of a manufacturing company's catalogue number and/or a catalogue (if any)); k.b) data on the safety and efficacy of a diagnostic product when used in vivo; k.c) quality assessment criteria and data on the stability of the diagnostic product (if necessary)."

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Who may apply — 'interested person' for registration; sponsor's in-country representative or a Georgian CRO for a clinical investigation

operators.interested-person-and-local-application

Fact-level verified

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 authorisation who is willing to have the product registered under the recognition or the national regime — any person may act as interested person under the recognition regime. For the registration of a medical-device clinical investigation the applicant may be the sponsor's authorised person: its official representation in Georgia or a clinical research organisation (CRO) registered in Georgia; a sponsor-investigator may apply only if it itself finances and carries out the manufacture of medical devices.

Conditions

The Law on Medicines defines the interested person for a 'homogeneity product'; the wording is not device-specific.
The clinical-investigation representation requirement is device-specific (Decree No. 386 of 3 October 2023, Art. 4(7)).

Language: Georgian. Verbatim, Decree No. 386 of 3 October 2023, Art. 4(7): "კვლევის ჩატარებაზე უფლების მისაღებად აპლიკანტი/განმცხადებელი შეიძლება იყოს სპონსორის უფლებამოსილი პირი: საქართველოში მისი ოფიციალური წარმომადგენლობა ან საქართველოში რეგისტრირებული კლინიკური კვლევის ორგანიზაცია (CRO). ასევე სპონსორ-მკვლევარი, მხოლოდ იმ შემთხვევაში, თუ იგი თავად აფინანსებს და აწარმოებს სამედიცინო მოწყობილობებს." Art. 1^1(49) of the Law on Medicines defines 'interested person': "a manufacturer, a trade licence holder, an importer or any other natural or legal person interested in the marketing authorisation of a homogeneity product, who is willing to have the pharmaceutical product registered in accordance with the recognition regime or national regime of state registration of a pharmaceutical product."

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Administrative fines for placing or making available a non-compliant product on the Georgian market

distribution.administrative-liability-for-non-compliant-placement

Fact-level verified

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 human life, health, property or the environment is an administrative offence punishable by a fine of GEL 1 000; the same act committed by the manufacturer, the authorised representative or the importer is punishable by a fine of GEL 1 500. Where the product poses a threat the fines are GEL 2 000 and, for the manufacturer, authorised representative or importer, GEL 3 000; where it poses a serious threat they are GEL 3 000 and GEL 4 000. Failure of an economic operator to provide the Agency with information required by Georgian legislation is punishable by a fine of GEL 500, and a repeat of any of these offences within one calendar year is punishable by double the respective amount. The case is examined by the Market Surveillance Agency, and its resolution — like a resolution on suspension of sale, withdrawal or recall — is appealed in the general courts of Georgia.

Conditions

These are administrative fines for the safety offences themselves, not charges for a regulatory service; they are recorded here because they are the consequence attached to the distribution prohibition, and not as fee data.
The liability attaches to an 'economic operator', which under Article 13²(1)(დ) includes the distributor and the person supplying the product directly to the user, not only the manufacturer.
Chapter III¹ (including Article 13¹¹) was inserted by Law of Georgia No 1447 of 1 April 2026; see the conditions on the operator-obligations fact for the difference between the Georgian and English consolidated renderings.

Language of source: Georgian. Verbatim Georgian: Art. 13^11(1) „ისეთი პროდუქტის ბაზარზე განთავსება ან ისეთი პროდუქტის ბაზარზე ხელმისაწვდომობის უზრუნველყოფა, რომელიც არ შეესაბამება აღნიშნული პროდუქტისთვის საქართველოს კანონმდებლობით დადგენილ მოთხოვნებს და საფრთხეს არ უქმნის ადამიანის სიცოცხლეს, ჯანმრთელობას, საკუთრებას ან/და გარემოს, − გამოიწვევს დაჯარიმებას 1 000 ლარით.“; (2) „იგივე ქმედება, ჩადენილი მწარმოებლის, ავტორიზებული წარმომადგენლის ან იმპორტიორის მიერ, − გამოიწვევს დაჯარიმებას 1 500 ლარით.“; (3) „…საფრთხეს უქმნის… − გამოიწვევს დაჯარიმებას 2 000 ლარით.“; (4) „…გამოიწვევს დაჯარიმებას 3 000 ლარით.“; (5) „…სერიოზულ საფრთხეს უქმნის… − გამოიწვევს დაჯარიმებას 3 000 ლარით.“; (6) „…გამოიწვევს დაჯარიმებას 4 000 ლარით.“; (7) „ეკონომიკური ოპერატორის მიერ ბაზარზე ზედამხედველობის ორგანოსთვის საქართველოს კანონმდებლობით განსაზღვრული ინფორმაციის მიწოდების ვალდებულების შეუსრულებლობა − გამოიწვევს დაჯარიმებას 500 ლარით.“; (8) repeats the offence within 1 calendar year and doubles the fine. English translation: (1) Placing on the market, or ensuring the availability on the market, of a product that does not comply with the requirements established for that product by Georgian legislation and does not pose a threat to human life, health, property and/or the environment shall result in a fine of GEL 1 000. (2) The same act committed by the manufacturer, authorised representative or importer shall result in a fine of GEL 1 500. (3) …poses a threat… GEL 2 000. (4) …GEL 3 000. (5) …poses a serious threat… GEL 3 000. (6) …GEL 4 000. (7) Failure by an economic operator to fulfil the obligation to provide the Agency with the information determined by Georgian legislation shall result in a fine of GEL 500. (8) A repeat within 1 calendar year doubles the amount. The appeal route is Article 13¹²(6): a resolution under Article 13¹¹, and a resolution of the Agency on suspension of sale, withdrawal and recall, are appealed in the general courts of Georgia under the procedure established by Georgian legislation.

Duties of an economic operator for a product placed on the Georgian market

distribution.economic-operator-obligations-and-market-surveillance-cooperation

Fact-level verified

An economic operator — a manufacturer, authorised representative, importer, distributor or the person supplying the product directly to the user, as defined by Article 4 of the Code — must meet the product-safety and placing-on-the-market requirements of Georgian legislation, and in the process of market surveillance must cooperate with the Market Surveillance Agency and give its representative access to the places of production, warehousing, storage and sale of products. When placing a product on the market or ensuring its availability the operator must ensure that the product complies with the requirements of the relevant technical regulation and that the relevant technical documentation has been prepared, and must keep that documentation for the period set by the same technical regulation for the purpose of submitting it to the Agency. The operator must indicate its own name, registered trade name or registered trademark, and contact information including its postal address, on the product, on its packaging or in the accompanying documentation. On the Agency's request it must supply the documents and information relating to the product determined by Georgian legislation, including information about the economic operators in the product's supply chain on the market. If it has information or a well-founded suspicion that a product it has made available on the market does not comply, it must immediately take all necessary corrective action as a voluntary measure; if the product carries a risk it must immediately notify the Agency and provide relevant information including on the non-compliance and on all corrective action taken. A manufacturer must not distribute any product that, to the best of its knowledge and belief, fails to comply with the mandatory safety requirements, and a manufacturer and a distributor must within their competence cooperate with the authorised bodies on the safety of products placed or intended to be placed on the market.

Conditions

Chapter III¹ of the Code (Articles 13¹–13¹³, market surveillance) was inserted by Law of Georgia No 1447 of 1 April 2026 and is rendered in force in the Georgian consolidated text; the consolidated English page still carries the whole chapter in a bracketed block marked '(Shall become effective from 1 June 2026)'. Both texts were read on 2026-09-16; the Georgian text is authoritative and the effective date has passed.
'Economic operator' is defined in Article 13²(1)(დ) by reference to Article 4 as the manufacturer, authorised representative, importer, distributor and the person or persons supplying the product directly to the user who are responsible for the safety of the product.
A distributor under the amended Article 4(5) is expressly a person who is not the manufacturer or the importer, so the distributor's own duties are the cooperation, availability, documentation, identity and notification duties above rather than the manufacturer's design and conformity duties.

Language of source: Georgian. Verbatim Georgian: Art. 13^5(2) „ეკონომიკური ოპერატორი ვალდებულია ბაზარზე ზედამხედველობის განხორციელების პროცესში ითანამშრომლოს ბაზარზე ზედამხედველობის ორგანოსთან და უზრუნველყოს ბაზარზე ზედამხედველობის ორგანოს წარმომადგენლის დაშვება პროდუქტის წარმოების, დასაწყობების, შენახვისა და რეალიზაციის ადგილებში.“; Art. 13^5(3) „ეკონომიკური ოპერატორი ვალდებულია პროდუქტის ბაზარზე განთავსებისას ან/და მისი ხელმისაწვდომობის უზრუნველყოფისას დარწმუნდეს, რომ პროდუქტი შეესაბამება სათანადო ტექნიკური რეგლამენტით დადგენილ მოთხოვნებს და შედგენილია შესაბამისი ტექნიკური დოკუმენტაცია. ეკონომიკურმა ოპერატორმა ასევე უნდა უზრუნველყოს აღნიშნული დოკუმენტაციის იმავე ტექნიკური რეგლამენტით განსაზღვრული ვადით შენახვა ბაზარზე ზედამხედველობის ორგანოსთვის წარსადგენად.“; Art. 13^5(4) „ეკონომიკური ოპერატორი ვალდებულია საკუთარი სახელი, რეგისტრირებული სავაჭრო სახელი ან რეგისტრირებული სავაჭრო ნიშანი, აგრეთვე საკონტაქტო ინფორმაცია, მათ შორის, საფოსტო მისამართი, შესაბამისი ტექნიკური რეგლამენტით დადგენილი მოთხოვნების დაცვით მიუთითოს პროდუქტზე, მის შეფუთვაზე ან თანდართულ დოკუმენტაციაში.“; Art. 13^5(5) „ბაზარზე ზედამხედველობის ორგანოს მოთხოვნის შემთხვევაში ეკონომიკური ოპერატორი ვალდებულია მიაწოდოს მას პროდუქტთან დაკავშირებული, საქართველოს კანონმდებლობით განსაზღვრული დოკუმენტები და ინფორმაცია, მათ შორის, ინფორმაცია პროდუქტის ბაზარზე მიწოდების ჯაჭვში ჩართული ეკონომიკური ოპერატორების შესახებ.“ Art. 9(4) and (6) were read in the English text: "A manufacturer must not distribute any product that, to the best of its knowledge and belief, fails to comply with the mandatory safety requirements." and "A manufacturer and a distributor shall, within their scope of competence, cooperate with the authorised bodies with respect to the safety of products already placed or intended to be placed on the market."

The operator roles through which a device reaches the Georgian market, in the wording in force from 1 June 2026

establishment.operator-roles-and-local-representation

Fact-level verified

A device reaches the Georgian market through the operator roles defined in Article 4 of the Code of Georgia on Product Safety and Free Movement, in the wording substituted by Law of Georgia No 1447 of 1 April 2026 with effect from 1 June 2026. A manufacturer is any natural or legal person that manufactures a product or places it on the market under its own name or its own trademark. A distributor is any natural or legal person in the supply chain that, within the scope of its activity, supplies the market with products and is not a manufacturer or an importer. An authorised representative is a natural or legal person authorised by the manufacturer, acting on the basis of a written power of attorney issued by the manufacturer, in the manufacturer's name, in order to perform the obligations determined by the Code and/or the relevant technical regulation; an authorised person may address the authorised representative instead of the manufacturer in relation to the requirements of the technical regulation. The importer / person responsible for placing the product on the market is the person responsible for placing on the market products manufactured in another country. 'Placing on the market' is the first making available of a product on the territory of Georgia, except for the free industrial zones, including through import, for commercial and/or non-commercial purposes; 'making available on the market' is any supply of a product on the territory of Georgia in the course of a commercial activity, for distribution or use/consumption, for payment or free of charge. Supplying a product to the manufacturer's own representation is expressly not placing on the market.

Conditions

This is the general product-safety operator set; it is not a device-specific establishment regime. The Code creates no establishment licence, importer registration or distributor permit here — see the unresolved entry for D08.
The amended Article 4 no longer contains the earlier Article 4(4)(b)–(c) limb that treated a foreign manufacturer's representative in Georgia, or the person engaged in placing products on the market where a foreign manufacturer had no representative in Georgia, as the manufacturer. The role that remains for a local actor is the authorised representative of Article 4(6).
The consolidated English text of document 1659419 still renders the pre-1-June-2026 paragraphs 4, 5, 6 and 8 as the operative text and carries the substitution in a bracketed block marked '(Shall become effective from 1 June 2026)'. The Georgian consolidated text of the same document carries the substituted wording as operative text with no pending-effective marker, and the effective date (1 June 2026) has passed; the Georgian text is the authoritative language, so the substituted wording is the one stated here. Checked against both texts on 2026-09-16.
Article 4(10)(a)–(f) lists what is not market placement: supply to the manufacturer's own representation; supply for further improvement (assembling, packaging, processing or labelling); a product not within the customs territory of Georgia; a product made in Georgia for export; a product intended for demonstration; and a product warehoused in Georgia and not available to end users.

Language of source: Georgian (authoritative consolidated text). Verbatim Georgian: Art. 4(4) „მწარმოებელი − ნებისმიერი ფიზიკური პირი ან იურიდიული პირი, რომელიც პროდუქტს აწარმოებს ან ბაზარზე განათავსებს საკუთარი სახელით ან საკუთარი სავაჭრო ნიშნით.“; Art. 4(5) „დისტრიბუტორი – მიწოდების ჯაჭვში ჩართული ნებისმიერი ფიზიკური პირი ან იურიდიული პირი, რომელიც თავისი საქმიანობის ფარგლებში პროდუქტით უზრუნველყოფს ბაზარს და არ არის მწარმოებელი ან იმპორტიორი.“; Art. 4(6) „ავტორიზებული წარმომადგენელი − მწარმოებლის მიერ ავტორიზებული ფიზიკური პირი ან იურიდიული პირი, რომელიც მოქმედებს მწარმოებლის მიერვე გაცემული წერილობითი მინდობილობის საფუძველზე, მწარმოებლის სახელით, ამ კოდექსით ან/და შესაბამისი ტექნიკური რეგლამენტით განსაზღვრული გარკვეული ვალდებულებების შესასრულებლად. ავტორიზებულ წარმომადგენელს მწარმოებლის ნაცვლად შეიძლება მიმართოს უფლებამოსილმა პირმა ტექნიკური რეგლამენტის მოთხოვნებთან დაკავშირებით.“; Art. 4(7) „იმპორტიორი/პროდუქტის ბაზარზე განთავსებისათვის პასუხისმგებელი პირი − პირი, რომელიც პასუხისმგებელია სხვა ქვეყანაში წარმოებული პროდუქტის ბაზარზე განთავსებისათვის.“; Art. 4(8) „ბაზარზე განთავსება – საქართველოს ტერიტორიაზე (გარდა თავისუფალი ინდუსტრიული ზონებისა) პროდუქტის პირველადი ხელმისაწვდომობის უზრუნველყოფა, მათ შორის, იმპორტის გზით, კომერციული მიზნით ან/და არაკომერციული მიზნით.“ English translation: (4) 'Manufacturer – any natural or legal person that manufactures a product or places it on the market under its own name or its own trademark.' (5) 'Distributor – any natural or legal person in the supply chain that, within the scope of its activity, supplies the market with products and is not a manufacturer or an importer.' (6) 'Authorised representative – a natural or legal person authorised by the manufacturer, acting on the basis of a written power of attorney issued by the manufacturer, in the manufacturer's name, in order to perform the obligations determined by this Code and/or the relevant technical regulation. An authorised person may address the authorised representative instead of the manufacturer in relation to the requirements of the technical regulation.' (7) 'Importer/person responsible for placing the product on the market – a person who is responsible for placing on the market products manufactured in another country.' (8) 'Placing on the market – the first making available of a product on the territory of Georgia (except for the free industrial zones), including through import, for commercial and/or non-commercial purposes.'

The Revenue Service must prevent the import of a product with a confirmed risk, and must suspend a product on the market surveillance authority's request

import.border-prevention-of-confirmed-risk-products

Fact-level verified

The Revenue Service — the Legal Entity under Public Law within the system of the Ministry of Finance of Georgia — is the border actor in Georgia's product-safety regime. If it has information about a product being brought into Georgian territory in relation to which there is a confirmed risk, it must take every possible measure to prevent that product from being brought into Georgian territory and must immediately notify the Market Surveillance Agency so that market surveillance measures can be carried out. To carry out market surveillance measures, where there is a well-founded suspicion or on the basis of risk analysis, the Agency may ask the Revenue Service to suspend a product; the Revenue Service must suspend the product for the period determined by Georgian legislation for product inspection and must not allow that product to be placed on the Georgian market by way of import. Where it is established that the product does not comply with the Code or the relevant technical regulation, or that there is a confirmed risk associated with it, the Revenue Service must not allow that product to be placed on the Georgian market by way of import.

Conditions

These are the border limbs of the general product-safety regime; they are not an import licence. No importer registration, import permit or prior import authorisation is created by Articles 13⁴(11)–(13) — see the unresolved entry for D08.
The market surveillance procedures may be carried out both within the customs control areas of Georgia and at the places of production, warehousing, storage and sale of products (Art. 13⁴(7)).
Article 13⁴ was inserted by Law of Georgia No 1447 of 1 April 2026; the Georgian consolidated text renders it in force and the English consolidated page still brackets it (see the operator-obligations fact).

Language of source: Georgian. Verbatim Georgian: Art. 13^4(11) „თუ საქართველოს ფინანსთა სამინისტროს მმართველობის სფეროში შემავალ საჯარო სამართლის იურიდიულ პირს − შემოსავლების სამსახურს (შემდგომ − შემოსავლების სამსახური) აქვს ინფორმაცია იმ პროდუქტის საქართველოს ტერიტორიაზე შემოტანის შესახებ, რომელთან დაკავშირებითაც არსებობს დადასტურებული საფრთხე, იგი ვალდებულია მიიღოს ყველა შესაძლო ზომა ამ პროდუქტის საქართველოს ტერიტორიაზე შემოტანის დაუშვებლობისთვის და ამის თაობაზე დაუყოვნებლივ შეატყობინოს ბაზარზე ზედამხედველობის ორგანოს საქართველოს კანონმდებლობით გათვალისწინებული ბაზარზე ზედამხედველობის ღონისძიებების განსახორციელებლად.“; (12) „ბაზარზე ზედამხედველობის ორგანო უფლებამოსილია ბაზარზე ზედამხედველობის ღონისძიებების განსახორციელებლად, საფუძვლიანი ეჭვის არსებობისას ან/და რისკის ანალიზზე დაყრდნობით მიმართოს შემოსავლების სამსახურს პროდუქტის შეჩერების თაობაზე. შემოსავლების სამსახური ვალდებულია შეაჩეროს პროდუქტი პროდუქტის შემოწმებისთვის საქართველოს კანონმდებლობით განსაზღვრული ვადით და არ დაუშვას ასეთი პროდუქტის იმპორტის გზით საქართველოს ბაზარზე განთავსება.“; (13) „თუ დადგინდება, რომ პროდუქტი არ შეესაბამება ამ კოდექსით ან/და შესაბამისი ტექნიკური რეგლამენტით დადგენილ მოთხოვნებს ან/და მასთან დაკავშირებით არსებობს დადასტურებული საფრთხე, შემოსავლების სამსახური ვალდებულია არ დაუშვას ასეთი პროდუქტის იმპორტის გზით საქართველოს ბაზარზე განთავსება.“ English translation: (11) If the Legal Entity under Public Law within the system of the Ministry of Finance of Georgia — the Revenue Service — has information about the bringing into Georgian territory of a product in relation to which there is a confirmed risk, it must take every possible measure to prevent that product from being brought into Georgian territory and must immediately notify the Market Surveillance Agency thereof in order to carry out the market surveillance measures provided for by Georgian legislation. (12) The Market Surveillance Agency is entitled, in order to carry out market surveillance measures, where there is a well-founded suspicion and/or on the basis of risk analysis, to apply to the Revenue Service for suspension of the product; the Revenue Service must suspend the product for the period determined by Georgian legislation for product inspection and must not allow such a product to be placed on the Georgian market by way of import. (13) If it is established that the product does not comply with the requirements established by this Code and/or the relevant technical regulation, and/or there is a confirmed risk associated with it, the Revenue Service must not allow such a product to be placed on the Georgian market by way of import.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Georgian-language patient information leaflet and a standard packaging/labelling sample

label.georgian-language-patient-information-leaflet

Fact-level verified

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 imported product, an authorised (attested) translation of the patient information leaflet into Georgian together with the original leaflet; for a product manufactured in Georgia a Georgian-language patient information leaflet is required. The translated leaflet must cover both personnel with medical and pharmaceutical education and customers where differential versions exist; the procedures are set by the Ministry.

Conditions

The provision is written for a 'pharmaceutical product' (Art. 11^11(19)(e)–(f)); the same article carries the device-type document lists, so the labelling duty is what attaches to the registered categories.
Investigational devices carry a separate duty: the device under investigation must be labelled to indicate that it is intended for investigation (Decree No. 386 of 3 October 2023, Art. 4(6)).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^11(19)(f): "in the case of registration of a pharmaceutical product manufactured in Georgia, a patient information leaflet in the Georgian language, and in the case of registration of an imported pharmaceutical product, an authorised (attested) translation of a patient information leaflet (information, which accompanies the pharmaceutical product, intended for both personnel with medical and pharmaceutical education, and for customers, if there are differential versions of the patient information leaflet) into the Georgian language and an original patient information leaflet, under procedures established by the Ministry;"

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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Binding product requirements in Georgia take the form of technical regulations adopted under law or by Government ordinance, and Georgia recognises EU technical regulations

legal-basis.instruments-for-medical-devices

Fact-level verified

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; technical regulations are adopted only under a law or by an ordinance of the Government of Georgia; and a technical regulation takes effect from the moment of its registration in the registry of technical regulations. Georgia recognises the technical regulations of the European Union in the regulated areas, and the Code's own definition of a 'new approach technical regulation' is a technical regulation adopted by the European Commission on the basis of the related new and global approach directive; products manufactured in compliance with new and global approach directives adopted or approved by the European Commission are stated to meet the basic safety requirements under the Code. The device-specific instrument in Georgia is therefore a technical regulation — the only one registered for medical devices is Government Decree No. 386 of 3 October 2023 on the clinical investigation of medical devices, as amended by Decree No. 334 of 7 October 2024 — and the medicines statute supplies the rules for the three device-type categories it pulls into pharmaceutical registration.

Conditions

Law of Georgia on Medicines and Pharmaceutical Activities (consolidated; matsne.gov.ge document 29836) — the state-regulation regimes, the registration article and the three device-type categories (dental material, invasive contraceptive mechanical devices, diagnostic products).
Government Decree No. 386 of 3 October 2023 approving the Technical Regulation on the clinical investigation of medical devices, as amended by Government Decree No. 334 of 7 October 2024 (matsne.gov.ge documents 5934377 and 6286437) — the only device-specific technical regulation registered in the registry of technical regulations.
Order No. 318/ნ of 10 December 2003 on state registration of medical technical items was repealed by Order No. 01-34/ნ of 12 June 2012 and has no successor technical regulation.
Article 3(1) of the Code places a product within a regulated area that is manufactured in a country with appropriate product safety standards and advanced quality infrastructure on the Georgian market without restriction, on the basis of a list of such countries to be defined by the Government of Georgia. No such list and no reliance route for a foreign device approval is recorded in this fact; it is flagged here because it sits on the same legal base.
The Code's definitions were substituted by Law of Georgia No 1447 of 1 April 2026 with effect from 1 June 2026 (see the D08 fact on operator roles for the wording and for a note on how matsne renders it).

Language of source: English consolidated text on matsne.gov.ge. Verbatim: Art. 56(1) "Any binding acts containing technical standards must be adopted in the form of technical regulations." Art. 56(11) "Georgia recognises the technical regulations of the European Union in the regulated areas." Art. 57(2) "A technical regulation shall take effect from the moment of its registration with the registry of technical regulations." Art. 58(2) "Technical regulations shall be adopted only under law or by an ordinance of the Government of Georgia." Art. 4(18) "New approach technical regulations –technical regulations adopted by the European Commission on the basis of the related new and global approach directive. The names of the new approach technical regulations and the related standards shall be published by the Legal Entity under Public Law (LEPL) – the National Agency for Standards and Metrology of Georgia." Art. 3(3) "Products, manufactured in compliance with new and global approach directives adopted/approved by the European Commission, shall meet the basic safety requirements under this Code." Every quoted sentence is the full text of its paragraph. This row replaces the earlier instrument inventory that stood as the value; the inventory now sits in conditions, so that the verified proposition is exactly the one the cited paragraphs state.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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The manufacturer's post-market duties in Georgia: warning end users, analysing risks and taking preventive measures including recall

pms.manufacturer-post-market-risk-analysis-and-corrective-measures

Fact-level verified

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 product when used as intended and within a predefined period of time, as well as of risks that may not be immediately apparent, and must provide for measures with respect to products that will enable it to analyse the risks the product may cause and to take appropriate measures to prevent risks, including warning end users and recalling products from end users and the market. It must provide a distributor with complete information about product-related risks so that the distributor can pass that information to a third party, and must within the scope of its activity contribute to ensuring the safety of products placed on the market. The manufacturer's post-market duty is therefore a continuing risk-analysis and preventive-action obligation that runs for as long as the product is on the market, and recall from end users and the market is one of the measures it must have provided for.

Conditions

This is the Code's general product-safety post-market duty. Georgia has no device-specific PMS, PMCF or periodic-safety-report regime, because the only registered device technical regulation (Decree No. 386 of 3 October 2023) governs clinical investigations rather than market placement; see the unresolved entry for D21.
The immediate notification duty that accompanies this obligation (Art. 11(5)) is a vigilance/reporting obligation and is recorded in the D18 fact only for its lot-identification and product-tracking limbs; the vigilance dimension is not in this market's list.
The market surveillance chapter adds post-market powers over the operator — the Agency may require suspension of sale, withdrawal, recall and destruction at the operator's expense (Art. 13⁶(1)), with a remedy period not exceeding 30 days for a non-threatening non-compliance (Art. 13⁶(2)). Those are authority powers rather than manufacturer PMS duties and are not written into this fact.

Language of source: English consolidated text on matsne.gov.ge. Verbatim: Art. 11(1) "A manufacturer shall, within its scope of competence, warn end users of any visible or invisible risks contained in a product when used as intended and within a predefined period of time, as well as of risks that may not be immediately apparent." Art. 11(3) "A manufacturer must, within its scope of competence, provide for measures with respect to products that will enable it to: a) analyse the risks that the product may cause; b) take appropriate measures to prevent risks, including, to warn end users and recall products from end users and the market." Art. 11(4) "A manufacturer must provide a distributor with complete information about product-related risks to enable the distributor to communicate this information to a third party." Art. 9(5) "A manufacturer must, within its scope of activity, contribute to ensuring safety of products placed on the market." Article 11 as a whole (paragraphs 1–6) and Article 9 (paragraphs 1–7) were read in full; Article 11 is not inside the pending 1 June 2026 block in the English consolidated text.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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The Departmental Registry is a public electronic document accessible via the internet; application forms are set by the Agency

portals.departmental-registry-public-and-agency-set-forms

Fact-level verified

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 manufacturing country, the brand name, the international off-patent name (if any), the form, the dosage and, where necessary, the concentration, the registration date, the registration validity period and an electronic version of a packaging and labelling sample. It is a public document, kept in electronic form and made accessible through the internet. The application form for a device clinical investigation is set by the Agency rather than by the decree.

Conditions

Under the recognition regime a product may be entered in the Departmental Registry proactively by the Agency, after an administrative review of homology identification documents, or after notification of first-time import in different packaging and labelling.
The Agency's own portal (rama.moh.gov.ge) could not be retrieved in this session (HTTP 403); the Registry's public and internet-accessible character is therefore cited from the Law rather than from the site.

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^6(2): "The Departmental Registry shall specify a registration number, an interested person, a manufacturing country, a brand name, an international off-patent name (if any), a form, a dosage, if necessary – a concentration, a registration date, registration validity period and an electronic version of a packaging and labelling sample." Art. 11^6(3): "The Departmental Registry shall be a public document. For the purpose of unobstructed access of the public to the information, the Departmental Registry shall be kept in an electronic form and shall be made accessible through the internet."

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Inspection of a device clinical investigation, and evidence of manufacture to the relevant standard

inspection.clinical-investigation-inspection-and-manufacturing-evidence

Fact-level verified

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 revokes its consent to a clinical investigation if, on the basis of an inspection of the clinical investigation, it is established that there is a high risk to the health and/or life of the investigation subjects, or that ethical and legal aspects were not observed during the investigation, as a result of which the rights and safety of the clinical investigation subject would be breached. The investigation dossier must also contain a document confirming manufacture of the device to the relevant standard, which may be filed as an original, a copy, an electronic document or another publicly available form with the source of obtaining indicated, accompanied by information confirming the right to manufacture the devices used in the investigation. The Agency may also require the certificate applicant or holder and the institution to submit any additional documentation and/or information connected with the investigation.

Conditions

This is inspection of a clinical investigation, not a manufacturer quality-system audit; no notified-body-style QMS audit is provided for, because no general device market-placement regime exists. See the unresolved entry for D12.
The manufacture document may be filed as a copy or an electronic document with the source indicated — a lower authentication standard than the notarised translations required elsewhere in the same article.
The Agency may also require additional documentation and/or information relating to the investigation (Art. 8(3)).
The Agency may refuse the certificate where the expert examination of the submitted documentation establishes that the clinical investigation is not scientifically substantiated (Art. 8(6)), and suspends the administrative proceedings, notifying the applicant not more than twice, where the documentation contains deficiencies (Art. 8(7)).

Language of source: Georgian (Government Decree No. 386 of 3 October 2023, Annex No. 1, the Technical Regulation). Verbatim Art. 7(1)(ზ): „კვლევაში გამოსაყენებელ სამედიცინო მოწყობილობაზე წარსადგენია შესაბამისი სტანდარტით წარმოების დამადასტურებელი დოკუმენტი, რომელიც შეიძლება წარდგენილ იქნეს როგორც ორიგინალის, ისე ასლის სახით ან ელექტრონული დოკუმენტის ან სხვა საჯაროდ ხელმისაწვდომი ფორმით, მოპოვების წყაროს მითითებით, კვლევაში გამოსაყენებელი სამედიცინო მოწყობილობების წარმოების უფლებამოსილების დამადასტურებელი ინფორმაციის თანხლებით;“ Art. 8(13): „სააგენტო აუქმებს კლინიკური კვლევის თანხმობას: ა) სპონსორის ან კლინიკური კვლევის რეგისტრაციის მფლობელის მოთხოვნით; ბ) თუ კლინიკური კვლევის ინსპექტირების საფუძველზე დადგინდა, რომ: ბ.ა) არსებობს კლინიკური კვლევის სუბიექტების ჯანმრთელობისთვის და/ან სიცოცხლისთვის მაღალი საფრთხე; ბ.ბ) კვლევის მიმდინარეობისას არ არის დაცული ეთიკისა და სამართლებრივი ასპექტები, რის გამოც დაირღვევა კლინიკური კვლევის სუბიექტის უფლებები და უსაფრთხოება.“ Art. 8(3): „სააგენტოს მოთხოვნის შემთხვევაში, რეგისტრაციის მოწმობის მაძიებელი/მოწმობის მფლობელი და დაწესებულება ვალდებულნი არიან, წარადგინონ კვლევასთან დაკავშირებული ნებისმიერი დამატებითი დოკუმენტაცია და/ან ინფორმაცია.“ English translation: Art. 7(1)(ზ) 'for the medical device to be used in the investigation a document confirming manufacture to the relevant standard must be submitted, which may be filed in the form of an original, a copy, an electronic document or another publicly available form, with the source of obtaining indicated, accompanied by information confirming the right to manufacture the medical devices used in the investigation;'; Art. 8(13) 'The Agency revokes its consent to the clinical investigation: a) at the request of the sponsor or the holder of the registration of the clinical investigation; b) if, on the basis of an inspection of the clinical investigation, it is established that: b.a) there is a high risk to the health and/or life of the clinical investigation subjects; b.b) the ethical and legal aspects were not observed during the investigation, as a result of which the rights and safety of the clinical investigation subject would be breached.'; Art. 8(3) 'On the request of the Agency, the applicant for the registration certificate / holder of the certificate and the institution are obliged to submit any additional documentation and/or information connected with the investigation.' CORRECTION TO THE PREVIOUS ROW: the earlier locator read 'Art. 7(13)(ბ)'. Article 7 of this regulation has only paragraphs 1 and 2; the inspection ground is Article 8(13)(ბ), and it has been re-located accordingly. Article 8 as a whole (paragraphs 1–19) was read in full to establish the correct paragraph. The source is the same instrument and the same article set; this row is a refresh in place, not a new claim.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Circulating a product outside the registration regimes — GEL 6,000 fine and seizure of the goods, GEL 12,000 if repeated

enforcement.penalty-for-circulation-outside-the-registration-regimes

Fact-level verified

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 Georgia, is punishable by a fine of GEL 6,000 and seizure of the goods in violation; the same act committed repeatedly carries a fine of GEL 12,000 and seizure (Art. 37^5). Related offences in Article 37^4 of the same chapter cover the sale of substandard, expired or spoilt product (GEL 6,000 and seizure, para. 7), circulation of counterfeit product (GEL 20,000 and seizure, para. 8) and breaches of the procedures for register entry, manufacturing, standardisation, labelling, transport, import/export, re-export, batch registration and destruction (GEL 1,600 and seizure, para. 9; repeated, para. 10).

Conditions

The penalties attach to 'pharmaceutical products' and to the categories registered under the Law on Medicines; there is no equivalent device-specific market-surveillance penalty in the instruments reviewed, because general medical goods are outside the registration regimes.
In the same chapter, a product may be seized by the Agency and destroyed at the owner's expense (Art. 17^1).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 37^5(1): "Circulation of a pharmaceutical product circumventing the regimes for granting marketing authorisation to a pharmaceutical product in Georgia and/or circulation of a pharmaceutical product that has not been granted a marketing authorisation in Georgia shall be subject to a fine in the amount of GEL 6 000 and to seizure of the subject in violation." Art. 37^5(2): "The same act committed repeatedly shall be subject to a fine in the amount of GEL 12 000 and to seizure of the subject in violation."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Two registration regimes — recognition and national — for the categories registered under the Law on Medicines

pathways.two-regimes-recognition-and-national

Fact-level verified

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 registration. The recognition regime applies to a product already authorised for the respective market by a foreign or international pharmaceutical-product regulator on the Government list; the national regime requires the full dossier of Art. 11^11. For the device-type categories this is the only registration pathway, and it is a local application whichever regime is used.

Conditions

The regimes are set out for a 'pharmaceutical product' (Art. 11^1(13)); the device-type categories (dental material, invasive contraceptive mechanical devices, diagnostic products) appear in the same registration article, whose document list is tailored to them in Art. 11^11(20)(i)–(k).
Circulation of a product that circumvents these regimes is an offence with a fine and seizure of the goods (Art. 37^5).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^4(1): "Marketing authorisation shall be granted to a pharmaceutical product under the following regimes: a) the recognition regime of state registration of a pharmaceutical product; b) the national regime of state registration of a pharmaceutical product."

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Georgia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Georgia (7 records)

GeorgiaUS FDA

Prior approval / evidence record

US FDA 510(k)/PMA

Authority: US FDA 510(k)/PMA
Accepted: No
Benefit: No recognition or abridged route for medical goods: the Law on Medicines recognition regime is written for pharmaceutical products and the only state-registration rule for medical technical items was repealed in 2012 without a successor. An FDA clearance is not a route onto the Georgian market; where a device is registered under the Law on Medicines it can serve as origin-country documentation alongside the ISO/EC certificate or free-sale certificate the dossier accepts in place of a certificate of pharmaceutical product.

Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10)Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GeorgiaMDSAP

Prior approval / evidence record

MDSAP

Authority: MDSAP
Accepted: No
Benefit: No MDSAP acceptance was evidenced in any Georgian instrument read this round; the clinical-investigation technical regulation names the Helsinki Declaration, ICH GCP and ISO 14155:2020 as the applicable standards and does not name MDSAP.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GeorgiaEU conformity assessment · ISO

Prior approval / evidence record

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

reliance.iso-ec-or-free-sale-certificate-in-lieu-of-cpp

Fact-level verified

Statement: For the three device-type categories that are registered under the Law on Medicines — dental material, invasive mechanical means of contraception, and means of diagnostics (test systems, allergens, reagents, sera) — the administrative dossier may carry, in place of a WHO-format Certificate of Pharmaceutical Product and in place of the GMP document or manufacturing licence that substitutes for it, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate. This is origin-country documentary evidence: it is required paperwork for the national registration dossier, and the Georgian registration decision is still taken locally.
Source Approval: EU EC certificate of the product manufacturer; ISO certificate of the product manufacturer; or a free sale certificate — accepted in lieu of a WHO-format Certificate of Pharmaceutical Product
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies only to the three categories named in Art. 11^11(19)(d): dental material, an invasive mechanic means of contraception, or means of diagnostics.
These are also the only device-type categories given their own registration document list in Art. 11^11(20)(i)–(k) (contraceptive mechanical devices, dental product, diagnostic products).
The alternative is offered in the same sub-paragraph that requires the CPP, so it displaces the CPP requirement rather than adding to it; the rest of the dossier under Art. 11^11(19)–(20) still applies.

Language of source: English consolidated text on matsne.gov.ge. Verbatim: "d) a (original) CPP in the form recommended by the World Health Organization, and if it is not available – a document certifying that the pharmaceutical product has been manufactured according to the GMP (Good Manufacturing Practices) standard, or a pharmaceutical product manufacturing licence issued by an authorised body of the manufacturing country. In the case of dental material, an invasive mechanic means of contraception, or means of diagnostics, an ISO certificate or an EC certificate of the product manufacturer, or a free sale certificate may be submitted;"

GeorgiaSource authority not specified

Prior approval / evidence record

Recognition regime — Georgia unilaterally recognises a foreign or international pharmaceutical-product marketing authorisation from a Government-compiled regulator list

reliance.recognition-regime-for-foreign-pharmaceutical-authorisation

Fact-level verified

Statement: Georgia's state registration has two regimes: a recognition regime and a national regime. The recognition regime applies to a product that has been granted a marketing authorisation in the respective market by a state body regulating pharmaceutical products in a foreign country or internationally, from a list of such bodies compiled by the Government of Georgia. Georgia unilaterally recognises the foreign safety, efficacy and quality requirements and does not repeat the expertise to determine safety, quality and therapeutic efficacy; the Georgian authorisation period follows the foreign one but is capped at 5 years.
Source Approval: a marketing authorisation for the respective market granted by a state body regulating pharmaceutical products in a foreign country or internationally, from the list compiled by the Government of Georgia under Art. 11^7(2); the Government list is Government Decree No. 188 of 22 October 2009
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The recognition regime is written for a 'pharmaceutical product' (Art. 11^1(13)). Whether it is also available to the three device-type categories registered under the same article (dental material, invasive contraceptive mechanical devices, diagnostic products) is not stated by the Law; their express foreign-evidence provision is Art. 11^11(19)(d).
A foreign authorisation from a body not on the Government list does not open the regime.
The Georgian marketing authorisation period is determined by the foreign authorisation period but may not exceed 5 years (Art. 11^7(8)).
The Government list is compiled under Art. 11^7(2); Decree No. 188 of 22 October 2009 is the instrument that list is made by (named in Decree No. 334 of 7 October 2024).

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^7(1): "The recognition regime of state registration of a pharmaceutical product shall be applicable to a pharmaceutical product that has been granted marketing authorisation in the respective market by a state body regulating pharmaceutical products in a foreign country or internationally." Art. 11^7(2): "The Government of Georgia shall compile a list of state bodies regulating pharmaceutical products in foreign countries or internationally for the purpose of recognising pharmaceutical products registered by them." Art. 11^4(3): "Georgia shall unilaterally recognise safety, efficacy, and quality requirements for granting market authorisation to a pharmaceutical product in markets under the control of this body, set by a state body regulating pharmaceutical products in a foreign country or internationally. Georgia shall not carry out a repeated expertise with regard to the above or similar requirements in order to determine the safety, quality and therapeutic efficacy of a pharmaceutical product." Art. 11^7(8): "The period of a marketing authorisation in Georgia granted to a pharmaceutical product registered through the recognition regime of state registration shall be determined as per the period of marketing authorisation granted in a market subject to the control of a foreign or interstate state authority regulating pharmaceutical products but for not more than 5 years."

GeorgiaSource authority not specified

Prior approval / evidence record

Recognised-country exemption for a next-generation device clinical investigation

reliance.recognised-country-prior-generation-clinical-investigation-exemption

Fact-level verified

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 recognised by Government Decree No. 188 of 22 October 2009 does not apply to a device clinical investigation that satisfies all of: (a) it is an analogue/replacement of a device of the same manufacturer that is already registered and has improved technical characteristics compared with that device; (b) the previous-generation model of the investigating device is in circulation on the market of a country/countries recognised by Decree No. 188; and (c) the manufacturing country/countries of the investigating device are on the list in that Decree. Instead of the recognised-country location, the applicant files an opinion of an authoritative sectoral professional association on the appropriateness (benefit/risk), a recommendation of the Georgian National Bioethics Council, and an informed-consent form stating that the international device clinical investigation is being conducted in Georgia for the first time and has not been conducted or is not under way in another country. The decision is taken by the Minister or by a specialist group formed for that purpose.
Source Approval: market circulation of the previous generation of the device in a country recognised by Government Decree No. 188 of 22 October 2009; manufacturing country/countries on the same list
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

This is an exemption from the location requirement for a clinical investigation, not a market-access approval; it sits upstream of any registration decision.
All three conditions (a), (b) and (c) must be met simultaneously.
The underlying requirement it displaces is Art. 7(2) of the technical regulation: where an international clinical investigation on humans is conducted for the first time, the registration documentation must contain pre-clinical results and the investigation must take place in a country recognised by Government Decree No. 188 of 22 October 2009 (as published on matsne.gov.ge, 04/10/2023, code 470000000.10.003.024219).
Decree No. 188 defines the list of recognised foreign and inter-state pharmaceutical-product regulators; the device provision borrows that list by reference.

Effective from 2024-10-08

Language: Georgian. Verbatim, Decree No. 334 of 7 October 2024, Art. 1: "ამ მუხლის მე-2 პუნქტით გათვალისწინებული მოთხოვნა ადამიანზე საერთაშორისო კლინიკური კვლევის „სხვა ქვეყნების ან სახელმწიფოთაშორისი ფარმაცევტული პროდუქტების მარეგულირებელი სახელმწიფო ორგანოების სიის განსაზღვრის შესახებ“ საქართველოს მთავრობის 2009 წლის 22 ოქტომბრის №188 დადგენილებით აღიარებულ ქვეყანაში მიმდინარეობასთან დაკავშირებით არ ვრცელდება იმ სამედიცინო მოწყობილობის კლინიკურ კვლევაზე, რომელიც აკმაყოფილებს ერთდროულად ქვემოთ ჩამოთვლილ ყველა პირობას: ა) წარმოადგენს იმავე მწარმოებლის მიერ უკვე რეგისტრირებული სამედიცინო მოწყობილობის ანალოგს/შემცვლელს და აქვს ამ სამედიცინო მოწყობილობასთან შედარებით გაუმჯობესებული ტექნიკური მახასიათებლები; ბ) საკვლევი სამედიცინო მოწყობილობის წინა თაობის მოდელი მიმოქცევაშია ... №188 დადგენილებით აღიარებული ქვეყნის/ქვეყნების ბაზარზე; გ) საკვლევი სამედიცინო მოწყობილობის მწარმოებელი ქვეყანა/ქვეყნები შედის/შედიან ამავე დადგენილებით გათვალისწინებული ქვეყნების ჩამონათვალში." Decree No. 334 entered into force on publication (website, 08/10/2024).

GeorgiaEU conformity assessment

Prior approval / evidence record

EU CE marking under MDR/IVDR

Authority: EU CE marking under MDR/IVDR
Accepted: No
Benefit: No recognition route for devices. An EC certificate of the product manufacturer is, however, expressly accepted in the administrative dossier of the three device-type categories registered under the Law on Medicines in place of a certificate of pharmaceutical product (Article 11^11(19)(d)), which is documentary relief rather than an approval. Georgia separately recognises EU technical regulations as such under Article 56(11) of the Product Safety and Free Movement Code.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GeorgiaEurasian Economic Union (EAEU)

Prior approval / evidence record

EAEU marketing authorisation

Authority: EAEU marketing authorisation
Accepted: No
Benefit: Georgia is not a member of the Eurasian Economic Union and recognises no EAEU medical-device marketing authorisation.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Agency decision deadlines — 3 months primary registration and Type-II variation, 2 months re-registration, 20 days Type IA, 40 days Type IB

clocks.agency-decision-deadlines

Fact-level verified

During the registration procedure the Agency must decide to register or refuse within 3 months for primary registration of a product or registration of a Type-II variation, within 2 months for re-registration or for registration and recording of a product, within 20 calendar days for a Type-IA variation and within 40 calendar days for a Type-IB variation, documented as an administrative act. The clock runs from the date of submission of a complete set of registration documents.

Conditions

These are deadlines for the registered categories under the Law on Medicines; no equivalent statutory clock was found for a general device pre-market review, because no such review exists.

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^11(9): "During the registration procedure, the Agency shall make the decision to register or refuse to register a pharmaceutical product or a variation within 3 months in the case of the primary registration of a pharmaceutical product or the registration of a Type-II variation, within 2 months – in the case of the re-registration or the registration and recording of a pharmaceutical product, within 20 calendar days – in the case of registration of a Type-I A variation, and within 40 calendar days – in the case of registration of a Type-I B variation, which shall be documented as an administrative act."

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Exemptions from registration — non-invasive contraceptive mechanical devices and certain pharmaceutical forms; voluntary registration for complementary products

derogation.exempt-products-and-unregistered-categories

Fact-level verified

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 prepared according to a magistral formula prescription and to an officinal prescription, and allergens designated for an individual natural person are not subject to registration. Complementary medicinal products, biologically active additives and paratherapeutic products are pulled into the Law's state-regulation mechanisms only if the interested person voluntarily registers them under the national regime of state registration.

Conditions

The exemption list is drawn from the Law on Medicines; it is the closest Georgian equivalent to a derogation or special-access route and is not a compassionate-use or emergency-use procedure.
The device-type categories the Law does register are dental material, invasive contraceptive mechanical devices and diagnostic products; non-invasive contraceptive mechanical devices fall outside even that.

Language of source: English consolidated text on matsne.gov.ge. Verbatim Art. 11^11(18): "A pharmaceutical substance, bulk and intermediary pharmaceutical products, pharmaceutical products prepared according to magistral formula prescription and officinal prescription, and allergens designated for an individual natural person shall not be subject to registration." Art. 1(4): "Non-invasive contraceptive mechanical devices shall be exempt from the state regulation provided for by this Law."

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Device clinical investigations must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020

standards.helsinki-ich-gcp-and-iso-14155-for-device-investigations

Fact-level verified

Clinical investigations of medical devices, including all measures relating to the protection of investigation subjects, must be conducted in accordance with the provisions of the Helsinki Declaration (adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964) as subsequently amended, and with the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and the International Organization for Standardization guideline 'Clinical investigation of medical devices for human subjects' (ISO 14155:2020) as subsequently amended. The clinical investigation plan and protocol must be drawn up to the GCP standard, and the investigation rules must conform to the ethical principles of the final version of the Helsinki Declaration.

Conditions

ISO 14155:2020 is named with its year, so the standard is fixed by reference rather than left open.
The same article of the technical regulation is the source of the ISO/EC certificate alternative in Art. 11^11(19)(d), which is the only device-specific recognition of a manufacturer's certificate.

Language: Georgian. Verbatim Art. 3(2): "კლინიკური კვლევები, მათ შორის, კვლევის სუბიექტების დაცვასთან დაკავშირებული ყველა ღონისძიება უნდა ჩატარდეს ჰელსინკის დეკლარაციის დებულებების შესაბამისად (მიღებულია მე-18 მსოფლიო სამედიცინო ასამბლეის მიერ ჰელსინკიში, ფინეთი, 1964 წელი), შემდგომში განხორციელებული უახლესი ცვლილებების გათვალისწინებით და ჰარმონიზაციის საერთაშორისო კონფერენციის (ICH) სახელმძღვანელო კარგი კლინიკური პრაქტიკისთვის (GCP) სტანდარტებისა და სტანდარტიზაციის საერთაშორისო ორგანიზაციის სახელმძღვანელო „ადამიანების მონაწილეობით სამედიცინო მოწყობილობების კლინიკური კვლევის“ (ISO 14155:2020) შესაბამისად, შემდგომში განხორციელებული უახლესი ცვლილებების გათვალისწინებით."

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Deemed registration if the Agency does not notify a refusal in time; refusal must be reasoned and in writing

submission.deemed-registration-on-agency-silence

Fact-level verified

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 to register within the statutory period, the product is considered registered and the Agency is obliged to issue the document confirming marketing authorisation in Georgia; that document is formalised within 10 days after the administrative act on registration. The administrative act and the marketing-authorisation document are equivalent documents.

Conditions

The deeming rule is tied to the Art. 11^11(9) clocks (3 months / 2 months / 20 days / 40 days) and to Art. 11^11(1)(d).
The registration decision is an administrative act under Georgian administrative law, so the general administrative appeal routes apply in addition.

Language of source: English consolidated text on matsne.gov.ge. Verbatim: "If the Agency refuses to register a pharmaceutical product, it shall immediately give a written notice of a reasonable refusal to an interested person. If an interested person is not notified about the decision not to register a pharmaceutical product within the time referred to in paragraphs 1(d) and 9 of this article, a pharmaceutical product shall be considered as registered, and the Agency shall be obliged to issue a document confirming marketing authorisation in Georgia. A document certifying marketing authorisation shall be formalised within 10 days after issuing an administrative act regarding the registration. An administrative act and a document certifying the marketing authorisation in Georgia shall be equivalent documents."

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Economic-operator identity marking, technical-document retention and supply-chain information for a product on the Georgian market

traceability.economic-operator-identity-and-supply-chain-information

Fact-level verified

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 information including its postal address, on the product, on its packaging or in the accompanying documentation, in compliance with the requirements of the relevant technical regulation. When placing a product on the market or ensuring its availability it must ensure that the product complies with the technical regulation and that the relevant technical documentation has been prepared, and must keep that documentation for the period set by the same technical regulation for the purpose of submitting it to the Market Surveillance Agency. On the Agency's request it must provide the documents and information relating to the product determined by Georgian legislation, including information about the economic operators involved in the product's supply chain on the market. Separately, a manufacturer must provide a distributor with complete information about product-related risks so that the distributor can communicate that information to a third party, and where a manufacturer or distributor knows or could have known that products it placed on the market carry risks that fail to comply with Georgian safety requirements it must immediately notify the authorised body with data identifying the product or its lot/group, full information on the risks, full information allowing the product to be tracked, and a description of the measures needed to avoid the risk.

Conditions

These are general product-safety duties that attach to devices as products; there is no device-specific traceability regulation in Georgia, because no device market-placement technical regulation has been made.
The Article 13⁵ duties apply to an 'economic operator', which under Article 13²(1)(დ) includes the manufacturer, authorised representative, importer, distributor and the person supplying the product directly to the user.
The Article 11(5)–(6) duty is the general product-safety notification duty and is quoted here because it carries the lot-identification and product-tracking limbs; the device-specific vigilance dimension is not in this market's list and is not assessed here.

Language of source: Georgian for Article 13⁵, English for Article 11 (the matsne English consolidated text; Article 11 is not part of the pending 1 June 2026 block). Verbatim Georgian Art. 13^5(4) „ეკონომიკური ოპერატორი ვალდებულია საკუთარი სახელი, რეგისტრირებული სავაჭრო სახელი ან რეგისტრირებული სავაჭრო ნიშანი, აგრეთვე საკონტაქტო ინფორმაცია, მათ შორის, საფოსტო მისამართი, შესაბამისი ტექნიკური რეგლამენტით დადგენილი მოთხოვნების დაცვით მიუთითოს პროდუქტზე, მის შეფუთვაზე ან თანდართულ დოკუმენტაციაში.“ and Art. 13^5(5) „ბაზარზე ზედამხედველობის ორგანოს მოთხოვნის შემთხვევაში ეკონომიკური ოპერატორი ვალდებულია მიაწოდოს მას პროდუქტთან დაკავშირებული, საქართველოს კანონმდებლობით განსაზღვრული დოკუმენტები და ინფორმაცია, მათ შორის, ინფორმაცია პროდუქტის ბაზარზე მიწოდების ჯაჭვში ჩართული ეკონომიკური ოპერატორების შესახებ.“ Verbatim English Art. 11(4) "A manufacturer must provide a distributor with complete information about product-related risks to enable the distributor to communicate this information to a third party." Art. 11(5) "If a manufacturer and a distributor know or could have known, to the best of their information and professional knowledge, that products they have placed on the market contain risks that fail to comply with safety requirements under the legislation of Georgia, they must immediately notify an appropriate authorised body and provide the following information: a) data to help accurately identify the product or its lot/group; b) full information of the risks contained in the product; c) full information that allows product tracking; d) description of measures required for risk avoidance." English translation of the Georgian: 13⁵(4) 'An economic operator must indicate its own name, registered trade name or registered trademark, and contact information including its postal address, in compliance with the requirements established by the relevant technical regulation, on the product, on its packaging or in the accompanying documentation.' 13⁵(5) 'On the request of the Market Surveillance Agency an economic operator must supply it with the documents and information relating to the product determined by Georgian legislation, including information about the economic operators involved in the supply chain of the product on the market.'

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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SUSAR reporting within 7 / 15 calendar days and an annual safety report during a device clinical investigation

vigilance.susar-and-annual-safety-reporting-in-clinical-investigations

Fact-level verified

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 the agreed investigation that are known to the sponsor and require expedited reporting: within no more than 7 calendar days of the sponsor becoming aware for fatal or life-threatening reactions, and within no more than 15 calendar days for all other SUSARs. For a multi-year clinical investigation a summary safety report is submitted periodically, once a year. The information is submitted to the Agency electronically, on CIOMS or MEDWATCH forms, in Georgian or English. The certificate holder must also file an Annual Progress Report once a year and a Clinical Study Report within 12 months of the end of the investigation (6 months for paediatric investigations).

Conditions

This is investigation-stage safety reporting under the device clinical-investigation technical regulation; no market-stage device vigilance reporting duty was found, because there is no general device market-placement regime.
Failure to file the annual and final reports entails the liability provided by law for the registration holder (Art. 8(19)).

Language: Georgian. Verbatim Art. 7(11): "სამედიცინო მოწყობილობების რეგისტრაციის მოწმობის მფლობელი პირი სააგენტოში წარადგენს ინფორმაციას სააგენტოსთან შეთანხმებული კვლევის ფარგლებში გამოვლენილი (სპონსორისთვის ცნობილი) საეჭვო მოულოდნელი სერიოზული გვერდითი რეაქციების (SUSAR) შესახებ, რომელიც მოითხოვს დაჩქარებულ ანგარიშგებას: ფატალური ან სიცოცხლისათვის საშიში – სპონსორისთვის ცნობიდან არაუგვიანეს 7 კალენდარული დღის, ხოლო ყველა სხვა საეჭვო მოულოდნელი სერიოზული გვერდითი რეაქციის შემთხვევაში – არაუგვიანეს 15 კალენდარული დღის ვადაში. მრავალწლიანი კლინიკური კვლევის შემთხვევაში, უსაფრთხოების შეჯამებული ანგარიშის წარდგენა ხდება პერიოდულად – წელიწადში ერთხელ. ზემოაღნიშნული ინფორმაციები სააგენტოს წარედგინება ელექტრონულად, CIOMS ან MEDWATCH ფორმების სახით, ქართულ ან ინგლისურ ენაზე."

Related structured datasets

Classification systems · 1 record

Open Georgian classes I, IIa, IIb and III →

georgia:medical-device

Jurisdiction Id

georgia

Domains

medical-device

Name

Georgian classes I, IIa, IIb and III

Description

Georgia's only in-force device class axis is Annex No. 1.1 to the medical-device clinical-investigation technical regulation approved by Government Decree No. 386 of 3 October 2023, which classifies medical devices — the definition includes in vitro diagnostic products, reagents included — into classes I, IIa, IIb and III on rules reproduced from the European model, with the usual duration-of-use and invasiveness distinctions. The class decides the clinical-investigation registration route: for classes IIa, IIb and III the Agency registers a clinical investigation only on the positive recommendation of the Coordination Council for clinical investigations of medical devices, while for the other classes the certificate is issued by Agency decision. General medical goods are not registered as devices at all, so the class axis does not gate market placement.

Classes

Id
i
Label
Class I — low risk
Normalized Risk Level
low
Id
iia
Label
Class IIa — medium risk
Normalized Risk Level
medium
Id
iib
Label
Class IIb — increased risk
Normalized Risk Level
high
Id
iii
Label
Class III — high risk
Normalized Risk Level
highest

Regulator

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Official Domains

matsne.gov.ge

Source Status

official-source-verified

Reference Sources

Title
Government Decree No. 386 of 3 October 2023, Article 3(5) — the Coordination Council recommendation for classes IIa, IIb and III
Url
https://matsne.gov.ge/ka/document/view/5934377
Reviewed On
2026-09-16
Supports
The class of the device determines the clinical-investigation registration route: registration for classes IIa, IIb and III is carried out by the Agency only on the basis of a positive recommendation of the Coordination Council for clinical investigations of medical devices, and a registration certificate for every other class is issued by decision of the Agency — the national consequence that makes the class axis operative in Georgia.
Title
Law of Georgia on Medicines and Pharmaceutical Activities, Article 1(1)(12) — 'medical goods' as a separate category
Url
https://matsne.gov.ge/en/document/view/29836
Reviewed On
2026-09-16
Supports
The Law regulates the circulation of pharmaceutical products and defines medical goods (instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products) as a separate category; the only device state-registration rule was repealed in 2012 and no successor device-registration technical regulation exists, which is why the class axis has no market-placement consequence.

Source Title

Government Decree No. 386 of 3 October 2023 approving the technical regulation on clinical investigations of medical devices, Annex No. 1.1 (classification rules) and Article 3(5)

Source Url

https://matsne.gov.ge/ka/document/view/5934377

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Georgia registration →

Country

Georgia

Jurisdiction Id

georgia

Country Code

Flag

🇬🇪

Regulator

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Regulator Abbrev

Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Region

europe

Tier

Risk Classification

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

Classes

Id
clinical-investigation-class-i
Class Name
Class I — clinical-investigation registration
Risk Level
low
Pathway
Application to the Agency; registration certificate issued by decision of the Agency
Official Timeline
Min
20
Max
20
Unit
working-days
Verification Status
official-verified
Official Source
Title
Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10)
Url
https://matsne.gov.ge/ka/document/view/5934377
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
Article 3(7) of the technical regulation: the Agency issues the registration certificate within 20 working days of submission of the application.
Article 3(8) adds 5 working days after a positive decision to enter the investigation in the register, which is public.
Article 3(9) makes registration a precondition of starting the investigation. Documents must be in Georgian or carry a notarised Georgian translation.
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
No
Id
clinical-investigation-classes-iia-iib-iii
Class Name
Classes IIa, IIb and III — clinical-investigation registration on a Council recommendation
Risk Level
highest
Pathway
Application to the Agency; registration only on the positive recommendation of the Coordination Council for clinical investigations of medical devices
Official Timeline
Min
20
Max
20
Unit
working-days
Verification Status
official-verified
Official Source
Title
Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10)
Url
https://matsne.gov.ge/ka/document/view/5934377
Accessed Date
2026-09-16
Realistic Timeline
Min
4
Max
8
Notes
The same 20-working-day clock of Article 3(7) applies, but for these three classes Article 3(5) interposes a prior step the clock does not cover: the Agency registers the investigation only on the positive recommendation of the Coordination Council, which is why the planning range is longer than for class I.
Healthy volunteers may take part only in clinical investigations of non-invasive class I devices (Article 6(4)), and a clinical investigation involving medical devices may not be carried out on a foreign national (Article 6(5)).
Investigations must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020 (Article 3(2)).
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
No
Id
medicines-primary-registration
Class Name
Any class — primary state registration under the Law on Medicines (national regime)
Pathway
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
Official Timeline
Min
3
Max
3
Unit
months
Verification Status
official-verified
Official Source
Title
Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period
Url
https://matsne.gov.ge/en/document/view/29836
Accessed Date
2026-09-16
Realistic Timeline
Min
5
Max
9
Notes
Article 11^11(9): during the registration procedure the Agency decides to register or refuse within 3 months for the primary registration of a product or the registration of a Type-II variation. Article 11^11(8) counts every period from the date a complete set of registration documents is submitted.
Article 11^11(10): if the applicant is not notified of a refusal within the statutory period the product is considered registered, and the marketing-authorisation document must be issued within 10 days of the administrative act.
This clock belongs to the Law on Medicines registration route, which reaches medical goods only through the three device-type categories named in Article 11^11(19)(d) and (20)(i)-(k). General medical goods are outside it, and no equivalent statutory clock exists for them because no general device review exists.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
medicines-re-registration
Class Name
Any class — re-registration and registration-and-recording under the Law on Medicines
Pathway
National regime of state registration, re-registration after expiry of the five-year validity period
Official Timeline
Min
2
Max
2
Unit
months
Verification Status
official-verified
Official Source
Title
Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period
Url
https://matsne.gov.ge/en/document/view/29836
Accessed Date
2026-09-16
Realistic Timeline
Min
4
Max
7
Notes
Article 11^11(9): the Agency decides within 2 months in the case of re-registration or of the registration and recording of a product.
Article 11^11(16): circulation is permissible for 5 years after registration, and after expiry of the registration validity period until expiry of the shelf life of the batches placed on the market; Article 11^11(15) revokes the marketing-authorisation document when the validity period expires.
On re-registration the applicant files the Article 11^11(9) documents plus at least four years of side-effect data from the five-year authorisation period (Article 11^11(7)).
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
US FDA 510(k)/PMA
Accepted
No
Benefit
No recognition or abridged route for medical goods: the Law on Medicines recognition regime is written for pharmaceutical products and the only state-registration rule for medical technical items was repealed in 2012 without a successor. An FDA clearance is not a route onto the Georgian market; where a device is registered under the Law on Medicines it can serve as origin-country documentation alongside the ISO/EC certificate or free-sale certificate the dossier accepts in place of a certificate of pharmaceutical product.
Authority
EU CE marking under MDR/IVDR
Accepted
No
Benefit
No recognition route for devices. An EC certificate of the product manufacturer is, however, expressly accepted in the administrative dossier of the three device-type categories registered under the Law on Medicines in place of a certificate of pharmaceutical product (Article 11^11(19)(d)), which is documentary relief rather than an approval. Georgia separately recognises EU technical regulations as such under Article 56(11) of the Product Safety and Free Movement Code.
Authority
EAEU marketing authorisation
Accepted
No
Benefit
Georgia is not a member of the Eurasian Economic Union and recognises no EAEU medical-device marketing authorisation.
Authority
MDSAP
Accepted
No
Benefit
No MDSAP acceptance was evidenced in any Georgian instrument read this round; the clinical-investigation technical regulation names the Helsinki Declaration, ICH GCP and ISO 14155:2020 as the applicable standards and does not name MDSAP.

Key Requirements

Establish whether the device is regulated at all: general medical goods (instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products) have no general pre-market registration in Georgia, while dental material, invasive mechanical means of contraception and means of diagnostics are registered under the Law on Medicines.
For a device under clinical investigation, file the application with the Agency in the form the Agency sets, with the registration fee receipt, the manufacturer's evidence of conformity with the applicable standard, the labelling indicating that the device is for investigation, and the other Article 7(1) documents, all in Georgian or with a notarised Georgian translation.
Appoint the sponsor's authorised person in Georgia — its official representation in Georgia or a clinical research organisation registered in Georgia — as the applicant for a clinical-investigation registration (Decree No. 386, Article 4(7)).
Register the clinical investigation before it starts; for classes IIa, IIb and III obtain first the positive recommendation of the Coordination Council for clinical investigations of medical devices (Decree No. 386, Articles 3(5), 3(7) and 3(9)).
Report suspected unexpected serious adverse reactions to the Agency within 7 calendar days for fatal or life-threatening cases and 15 calendar days otherwise, and file a summary safety report annually for multi-year investigations (Decree No. 386, Article 7(11)).
Where a Georgian marketing authorisation is required for one of the three registered device-type categories, file the administrative part of the dossier including the application, the certificate of pharmaceutical product or an ISO or EC certificate of the manufacturer or a free sale certificate in its place, the packaging and labelling sample, the Georgian-language patient information leaflet and the registration fee receipt (Law on Medicines, Article 11^11(19)).
Where the device is radio equipment, have it certified by an accredited centre or laboratory under the GNCC certification regulation and carry the CE or GES conformity marking and the responsible body's identification number before placing it on the market (Law on Electronic Communications, Articles 58(2) and 59; GNCC Decree No. 2, Article 16).
Where the equipment uses the radio-frequency spectrum, hold the spectrum-use authorisation, licence or scarce-resource right from the Commission before operating it (Law on Electronic Communications, Article 43(4)).
Where the device is non-infectious, non-implantable electrical or electronic equipment, register in the extended-producer-responsibility electronic registry before placing it on the Georgian market, and obtain Ministry authorisation for an individual compliance scheme (Government Decree No. 326 of 2020, Articles 6(1) and 7(5)).
Where dental, intraoral or osteodensitometry X-ray diagnostic equipment is used, hold the Nuclear and Radiation Safety Agency's authorisation and comply with the radiation-safety technical regulation's dose-monitoring, diagnostic-reference-level and quality-assurance duties (Law No 3284-XIმს-Xმპ, Articles 16(2) and 19(1); Government Decree No. 77 of 17 March 2025, Articles 31(5) and 32-33).

Local Rep Required

Yes

Local Rep Name

For a clinical investigation, the sponsor's authorised person in Georgia — its official representation in Georgia or a clinical research organisation (CRO) registered in Georgia, which is the applicant under Article 4(7) of the clinical-investigation technical regulation; for state registration under the Law on Medicines the applicant is an interested person such as the manufacturer, a trade licence holder or an importer

Mdsap Accepted

Mdsap Benefit

None evidenced. The device clinical-investigation technical regulation fixes the applicable standards as the Helsinki Declaration, ICH GCP and ISO 14155:2020, and the Law on Medicines asks for a manufacturer's quality document or an ISO or EC certificate of the manufacturer rather than a certified quality-management-system audit.

Registration Validity

Clinical-investigation registration certificate — issued for the period requested by the applicant, corresponding to the investigation plan and the insurance period (Decree No. 386, Article 3(10)). Marketing authorisation for a registered product — circulation permissible for 5 years after registration (Law on Medicines, Article 11^11(16)).

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10)
Url
https://matsne.gov.ge/ka/document/view/5934377
Accessed Date
2026-09-16
Title
Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period
Url
https://matsne.gov.ge/en/document/view/29836
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Regulation Agency for Medical and Pharmaceutical Activities (RAMA). Appoint a For a clinical investigation, the sponsor's authorised person in Georgia — its official representation in Georgia or a clinical research organisation (CRO) registered in Georgia, which is the applicant under Article 4(7) of the clinical-investigation technical regulation; for state registration under the Law on Medicines the applicant is an interested person such as the manufacturer, a trade licence holder or an importer.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Regulation Agency for Medical and Pharmaceutical Activities (RAMA) including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Regulation Agency for Medical and Pharmaceutical Activities (RAMA) reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Regulation Agency for Medical and Pharmaceutical Activities (RAMA) may issue questions.
Duration
20 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Regulation Agency for Medical and Pharmaceutical Activities (RAMA) issues Georgia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Georgia fees →

Jurisdiction Id

georgia

Country

Georgia

Country Code

Authority

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)

Low Risk Local

Min: 10000
Max: 10000
Currency: GEL
Per Product: Yes

High Risk Local

Min: 30000
Max: 30000
Currency: GEL
Per Product: Yes

Details

Id
clinical-investigation-application-class-i
Item
Medical-device clinical-investigation application review fee — Class I
Currency
GEL
Amount Local
10000
Amount Local Formatted
GEL 10,000
Frequency
Per application
Notes
Column 26 of the Article 5 table of Decree No. 586 of 2 December 2019, inserted by Decree No. 384 of 3 October 2023.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://matsne.gov.ge/ka/document/view/5934355
Source Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Verified On
2026-09-16
Id
clinical-investigation-application-classes-iia-iib-iii
Item
Medical-device clinical-investigation application review fee — Classes IIa, IIb and III
Currency
GEL
Amount Local
30000
Amount Local Formatted
GEL 30,000
Frequency
Per application
Notes
Column 26.1 of the same table, inserted by Decree No. 384 of 3 October 2023; the tariff is flat across the three higher classes.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://matsne.gov.ge/ka/document/view/5934355
Source Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Verified On
2026-09-16
Id
clinical-investigation-validity-extension-class-i
Item
Extension of the validity of a Class I medical-device clinical-investigation certificate
Currency
GEL
Amount Local
5000
Amount Local Formatted
GEL 5,000
Frequency
Per extension
Notes
Same column of the amended Article 5 table.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://matsne.gov.ge/ka/document/view/5934355
Source Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Verified On
2026-09-16
Id
clinical-investigation-validity-extension-classes-iia-iib-iii
Item
Extension of the validity of a Classes IIa, IIb and III medical-device clinical-investigation certificate
Currency
GEL
Amount Local
15000
Amount Local Formatted
GEL 15,000
Frequency
Per extension
Notes
Same column of the amended Article 5 table.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://matsne.gov.ge/ka/document/view/5934355
Source Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Verified On
2026-09-16
Id
clinical-investigation-certificate-amendment
Item
Amendment of a medical-device clinical-investigation certificate
Currency
GEL
Amount Local
1000
Amount Local Formatted
GEL 1,000
Frequency
Per amendment
Notes
Same column of the amended Article 5 table.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://matsne.gov.ge/ka/document/view/5934355
Source Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Verified On
2026-09-16

Notes

These are the only fees this round could evidence for a medical device in Georgia, and they are charged for a clinical investigation, not for a market-placement registration: Georgia has no general medical-device pre-market registration, so a device that is not the subject of a clinical investigation attracts no RAMA device fee.
The bands above map the tariff's own risk graduation: the Class I rate is the low-risk band and the single flat Classes IIa/IIb/III rate is the high-risk band.
Refusal of a clinical-investigation application refunds 70 per cent of the fee paid, per the same column of the amended Article 5 table.
No amount fixing a medical-device state-registration fee was located. The Law on Medicines requires evidence of payment of a registration fee (Articles 11^11(7) and 11^11(19)(ზ)) and Article 11^11(23) states that the amount of the state-registration fee for a pharmaceutical product under the national regime is fixed by law, but that article governs pharmaceutical products; the category of medical goods has no registration regime or fee attached.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Government Decree No. 586 of 2 December 2019 — types of service provided by the LEPL Regulation Agency for Medical and Pharmaceutical Activities, the amount of the fee and the rules for its payment, refund and exemption, Article 5 table, as amended by Government Decree No. 384 of 3 October 2023
Url
https://matsne.gov.ge/ka/document/view/5934355
Accessed Date
2026-09-16
Title
Government Decree No. 586 of 2 December 2019 — the parent fee schedule whose Article 5 table the 2023 amendment extends
Url
https://matsne.gov.ge/ka/document/view/4719991
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Georgia certifications →

Slug

georgia

Market

Georgia

Confidence

high

Schemes

Id
georgia-radio-equipment-certification
Name
Radio equipment and telecommunications terminal equipment certification
Category
Radio Spectrum
Status
Mandatory Pre Market
Object
Radio Equipment
Note
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.
Source Urls
https://matsne.gov.ge/ka/document/view/29620
https://matsne.gov.ge/ka/document/view/1195888
Source Binding
reviewed
Id
georgia-radio-spectrum-use-authorisation
Name
Radio-frequency spectrum use authorisation
Category
Radio Spectrum
Status
Mandatory For Use Site
Object
Radio Equipment
Note
Article 43(4) of the Law of Georgia on Electronic Communications forbids the use of the radio-frequency spectrum or of numbering resources without the authorisation, licence or right to use a scarce resource obtained in the electronic-communications field. Article 47(4) makes the allocation and regulation of the radio spectrum a competence of the Commission, and Article 47(6) provides that the spectrum-use right is acquired by licence, auction or contest. This is a use-site condition on the operator, distinct from the equipment certification above.
Source Urls
https://matsne.gov.ge/ka/document/view/29620
Source Binding
reviewed
Id
georgia-radio-equipment-emc-requirements
Name
Electromagnetic compatibility essential requirements for radio equipment
Category
emc
Status
Mandatory If Feature
Object
Radio Equipment
Note
Georgia's electromagnetic-compatibility obligation for devices sits inside the radio-equipment regime: Annex 1 to GNCC Decree No. 2 of 24 December 2004 sets out the EMC essential requirements (ელექტრომაგნიტური ხელშეშლისაგან დაცვის ძირითადი მოთხოვნები) against which radio-equipment certification is carried out, and the radio-equipment technical regulation approved by Government Decree No. 161 of 24 April 2023 governs the placing of radio equipment on the market (its technical regulation is published as an attachment to the decree). An EMC obligation therefore attaches to a medical device where the device is radio equipment; no standalone EMC regulation for non-radio medical electrical devices was evidenced from these sources.
Source Urls
https://matsne.gov.ge/ka/document/view/5788697
https://matsne.gov.ge/ka/document/view/1195888
Source Binding
reviewed
Id
georgia-low-voltage-medical-exclusion
Name
Low-voltage equipment technical regulation — medical electrical equipment excluded
Category
Medical Electrical Safety
Status
Evidence Only No Separate Certificate
Object
Finished Device
Note
Georgia does have a low-voltage technical regulation — Government Decree No. 165 of 1 May 2023, registered in the Technical Regulations Registry as No. 305 of 2 May 2023 — which applies to electrical equipment designed for use between 50 and 1000 volts alternating current and 75 and 1500 volts direct current (Article 1(2)). Annex II(1)(ბ) excludes electrical equipment intended for radiological and medical purposes from its scope, so a medical electrical device carries no Georgian low-voltage conformity certificate. The regulation's own conformity route is internal production control (Annex III Module A) with a declaration of conformity under Article 12.
Source Urls
https://matsne.gov.ge/ka/document/view/5793798
Source Binding
reviewed
Id
georgia-legal-metrology-not-applicable
Name
Legal metrology type approval and verification — closed list without healthcare instruments
Category
Legal Metrology
Status
Evidence Only No Separate Certificate
Object
Measuring Instrument
Note
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.
Source Urls
https://matsne.gov.ge/ka/document/view/1659419
https://matsne.gov.ge/ka/document/view/2156383
https://matsne.gov.ge/ka/document/view/6376048
Source Binding
reviewed
Id
georgia-ionizing-radiation-authorisation
Name
Radiation-protection authorisation for the use of X-ray diagnostic equipment
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Radiation Emitting Equipment
Note
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.
Source Urls
https://matsne.gov.ge/ka/document/view/5827850
https://matsne.gov.ge/ka/document/view/6447132
Source Binding
reviewed
Id
georgia-weee-and-batteries-registration
Name
Waste electrical and electronic equipment producer responsibility — importer registration
Category
Environmental And Batteries
Status
Mandatory Pre Market
Object
Finished Device
Note
Government Decree No. 326 of 2020 approves the technical regulation on waste electrical and electronic equipment. Article 2(1) applies it to all electrical and electronic equipment placed on the Georgian market; Article 2(3)(k) excludes only infectable medical devices and in vitro diagnostic devices and active implantable medical devices, so non-infectious, non-implantable medical electrical equipment is in scope. Article 3 defines the manufacturer to include an importer that first places the equipment on the market, Article 6(1) requires registration in the electronic registry of the extended-producer-responsibility system before placing on the market, and Article 7(5) requires Ministry authorisation for an individual compliance scheme. A separate battery and accumulator producer-responsibility regulation is approved by Government Decree No. 324 of 2020. No packaging producer-responsibility instrument was located.
Source Urls
https://matsne.gov.ge/ka/document/view/4877952
https://matsne.gov.ge/ka/document/view/4877915
Source Binding
reviewed
Id
georgia-technical-regulation-framework
Name
Technical regulations as the only binding product requirement, with EU technical regulations recognised
Category
General Electrical Components
Status
Evidence Only No Separate Certificate
Object
Covered Product Or Component
Note
The Product Safety and Free Movement Code fixes how product requirements bind in Georgia. Article 56(1) requires any binding act containing technical standards to be adopted as a technical regulation; Article 58(2) allows technical regulations to be adopted only under a law or by ordinance of the Government; Article 57(2) makes a technical regulation take effect only from its registration in the registry of technical regulations, which Article 61(1) entrusts to the Ministry of Justice; and Article 56(11) states that Georgia recognises the technical regulations of the European Union in the regulated areas. The consequence for a device file is that no Georgian conformity certificate can exist for a product family for which no technical regulation has been registered — and that an EU technical regulation is the recognised benchmark where one exists.
Source Urls
https://matsne.gov.ge/ka/document/view/1659419
Source Binding
reviewed

Official Sources

Authority
LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)
Topic
Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices (reg. code 470000000.10.003.024219)
Url
https://matsne.gov.ge/ka/document/view/5934377
Authority
Parliament of Georgia
Topic
Law of Georgia on Medicines and Pharmaceutical Activities — state registration regimes, clocks and validity
Url
https://matsne.gov.ge/en/document/view/29836
Authority
Georgian National Communications Commission (ComCom)
Topic
Law of Georgia on Electronic Communications — Article 43(4) spectrum use, Article 58(2) and 59 certification of radio equipment
Url
https://matsne.gov.ge/ka/document/view/29620
Authority
Georgian National Communications Commission (ComCom)
Topic
GNCC Decree No. 2 of 24 December 2004 — certification regulation, Annex 1 electromagnetic-compatibility essential requirements
Url
https://matsne.gov.ge/ka/document/view/1195888
Authority
Government of Georgia
Topic
Government Decree No. 161 of 24 April 2023 — radio equipment technical regulation (electrical safety, EMC and spectrum)
Url
https://matsne.gov.ge/ka/document/view/5788697
Authority
Government of Georgia
Topic
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)
Url
https://matsne.gov.ge/ka/document/view/5793798
Authority
Parliament of Georgia
Topic
Code of Georgia on Product Safety and Free Movement — Articles 56, 57, 58, 61 and Article 80 legalised measurement means
Url
https://matsne.gov.ge/ka/document/view/1659419
Authority
Government of Georgia
Topic
Government Decree No. 369 of 24 December 2013 — type approval and verification of measuring instruments
Url
https://matsne.gov.ge/ka/document/view/2156383
Authority
Government of Georgia
Topic
Government Decree No. 480 of 31 December 2024 — measuring instruments regime in force 1 December 2028 (meters, flow, weighing, level gauges, exhaust analysers)
Url
https://matsne.gov.ge/ka/document/view/6376048
Authority
Parliament of Georgia
Topic
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)
Url
https://matsne.gov.ge/ka/document/view/5827850
Authority
Government of Georgia
Topic
Government Decree No. 77 of 17 March 2025 — radiation-safety technical regulation, in force 1 June 2025 (reg. code 300160070.10.003.024968)
Url
https://matsne.gov.ge/ka/document/view/6447132
Authority
Government of Georgia
Topic
Government Decree No. 326 of 2020 — technical regulation on waste electrical and electronic equipment, producer registration and individual compliance schemes
Url
https://matsne.gov.ge/ka/document/view/4877952
Authority
Government of Georgia
Topic
Government Decree No. 324 of 2020 — producer responsibility for batteries and accumulators
Url
https://matsne.gov.ge/ka/document/view/4877915
Authority
LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)
Topic
Government Decree No. 586 of 2 December 2019 — RAMA services, fee amounts, payment, refund and exemption rules
Url
https://matsne.gov.ge/ka/document/view/4719991
Authority
Government of Georgia
Topic
Government Decree No. 384 of 3 October 2023 — amending Decree No. 586, adding the medical-device clinical-investigation fees
Url
https://matsne.gov.ge/ka/document/view/5934355

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Need to apply Georgia's requirements to a product?

Confirm the current Regulation Agency for Medical and Pharmaceutical Activities (RAMA) pathway, evidence, and local-role details for the actual device before filing.

Pricing

Advertising, claims & promotion

Medical devices are advertising goods under Georgia's general Law on Advertising; there is no device-specific advertising regime

Approval validity & renewal

Five-year circulation period; re-registration documents due two months before expiry; recognition-regime validity capped at five years

Authority & regime

Competent authority — 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

Change control

Variations are registered as Type IA, Type IB and Type II, with their own clocks and no extension of the validity period

Classification rules

Four risk classes (I, IIa, IIb, III) with EU-style classification rules in Annex No. 1.1 to the device technical regulation

Clinical investigation & performance

Device clinical investigations are registered with the Agency; class IIa/IIb/III need a positive Coordination Council recommendation

Device definition & scope

Device definition — instruments, apparatus, appliances, software, implants, reagents and materials for stated medical purposes, including in-vitro examination of human samples

'Medical goods' are a separate statutory category from 'pharmaceutical product' — and non-invasive contraceptive mechanical devices are exempt outright

Dossier requirements

Clinical-investigation registration dossier — application and fee receipt, notarised mandate, protocol, insurance, ethics opinion, investigator documentation

Dossier for the three device-type categories — a short, category-specific list

Economic-operator roles

Who may apply — 'interested person' for registration; sponsor's in-country representative or a Georgian CRO for a clinical investigation

Establishment, import & distribution

Administrative fines for placing or making available a non-compliant product on the Georgian market

Duties of an economic operator for a product placed on the Georgian market

The operator roles through which a device reaches the Georgian market, in the wording in force from 1 June 2026

The Revenue Service must prevent the import of a product with a confirmed risk, and must suspend a product on the market surveillance authority's request

Label, IFU & language

Georgian-language patient information leaflet and a standard packaging/labelling sample

Legal basis & guidance

Binding product requirements in Georgia take the form of technical regulations adopted under law or by Government ordinance, and Georgia recognises EU technical regulations

Manufacturer PMS

The manufacturer's post-market duties in Georgia: warning end users, analysing risks and taking preventive measures including recall

Official forms & portals

The Departmental Registry is a public electronic document accessible via the internet; application forms are set by the Agency

QMS, audit & inspection

Inspection of a device clinical investigation, and evidence of manufacture to the relevant standard

Recall, FSCA & market surveillance

Circulating a product outside the registration regimes — GEL 6,000 fine and seizure of the goods, GEL 12,000 if repeated

Registration pathways

Two registration regimes — recognition and national — for the categories registered under the Law on Medicines

Reliance & recognition

Georgia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Georgia (7 records)

US FDA 510(k)/PMA

MDSAP

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

Recognition regime — Georgia unilaterally recognises a foreign or international pharmaceutical-product marketing authorisation from a Government-compiled regulator list

Recognised-country exemption for a next-generation device clinical investigation

EU CE marking under MDR/IVDR

EAEU marketing authorisation

Review clocks

Agency decision deadlines — 3 months primary registration and Type-II variation, 2 months re-registration, 20 days Type IA, 40 days Type IB

Special access & derogation

Exemptions from registration — non-invasive contraceptive mechanical devices and certain pharmaceutical forms; voluntary registration for complementary products

Standards, testing & ancillary approvals

Device clinical investigations must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020

Submission communications & appeal

Deemed registration if the Agency does not notify a refusal in time; refusal must be reasoned and in writing

UDI, listing & traceability

Economic-operator identity marking, technical-document retention and supply-chain information for a product on the Georgian market

Vigilance & incident reporting

SUSAR reporting within 7 / 15 calendar days and an annual safety report during a device clinical investigation

Related structured datasets

More Georgia medical device resources