Georgia Medical Device Labelling: Georgian Language Requirements and Inspection Exposure

1. Key takeaways

Medical devices circulating in the Georgian market must carry Georgian content on the label and instructions for use of the smallest sales unit. English may run in parallel but cannot substitute. The legal basis is the consumer information obligation of Chapters II and III of the Product Safety and Free Movement Code, Law No. 6157-Iს of 8 May 2012, applied through Article 3(2), together with the language policy reflected in the notarised Georgian translation requirement of Government Decree No. 386 of 3 October 2023.

An important structural point: the language obligation does not sit in the registration provisions. It flows from the general consumer information requirements of the Code. That position in the legal hierarchy means labelling is an independent and continuing obligation, and a product that enters the market through the classification confirmation letter pathway is not exempt from it.

Enforcement exposure is concrete. Government Decree No. 278 of 1 August 2023 allows inspections without prior notice, covering both documents and physical goods. Label language is the violation that is easiest to detect and easiest to evidence during such an inspection, because the label sits on the shelf. Technical file imperfections are hard to discover on the spot; a missing Georgian label is in plain view. Labelling should therefore be treated as a high-frequency inspection item and prepared accordingly.

Under Article 3(2), the information duties of Chapters II and III attach to the smallest sales unit placed on the market. That means the Georgian text must appear on the packaging the end user actually receives, not only on a leaflet distributed separately or on a website. A single label line in Georgian is also not enough; the obligations cover the information necessary for safe use, which in practice means the warning text, the usage instructions and the identification of the manufacturer and the batch. Because the specific element list is a practical estimate rather than a written enumeration, the conservative approach is to exceed it: covering more elements than the market minimum costs little in artwork and removes any argument about which elements are mandatory.

Practically, correct labelling also protects distributors. A distributor cannot verify an English label against local expectations, and distributors selling products with non-conforming labelling share enforcement exposure. Providing correct Georgian labels at the manufacturing stage removes that risk for the entire supply chain, and it costs a fraction of what a relabeling campaign after a market withdrawal would cost.

2. Legal basis

1. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012: Article 3(2) (Chapters II and III apply where no dedicated technical regulation exists) and Article 2(1) (basic principles of the Code).
2. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009, Article 11³ (Article 113): restrictions on advertising and claims.
3. Article 1¹: the definitions of medical supplies and of an interested party.
4. Government Decree No. 386 of 3 October 2023 of Georgia, Article 4: documents must be accompanied by notarised Georgian translations.
5. Government Decree No. 278 of 1 August 2023 of Georgia: the authority may conduct inspections without prior notice, covering documents and physical goods.
6. Practical estimate statement: the specific list of label elements and the side-by-side bilingual rules are not prescribed in any official legal text; they derive from prevailing industry practice.

3. Expert insights

Insight one: the language requirement attaches to the consumer information obligation, not to the registration clause.

Georgia does not state the label language in its registration provisions; the obligation comes from the general requirements of Chapters II and III of the Code. This position matters in practice. Because the duty is independent of the registration act, it persists for as long as the product is on the market, and it cannot be argued away by pointing to the registration pathway used. Companies that treat labelling language as a one-time registration task, rather than as a continuing obligation, accumulate compliance debt that surfaces at the first inspection.

Insight two: the notarised translation standard of Government Decree No. 386 of 3 October 2023 reveals the compliance level expected of translation.

For the documents it enumerates, Georgia requires translations at notarisation level. Labels and instructions for use are not explicitly listed objects of the decree, but preparing them to the same standard removes disputes during review and inspection. It is a low-cost, high-certainty practice: the marginal expense of notarised-quality translation work is small compared with the cost of a labelling violation found during an unannounced inspection.

The same logic applies to the instructions for use. Errors in translated warnings are the classic failure mode of device labelling, and a notarisation-level workflow with independent review and retained records is the established countermeasure. It also shortens the artwork cycle, because a translation that passes a documented verification process the first time does not come back for rework.

Insight three: Government Decree No. 278 of 1 August 2023 makes labelling a high-frequency inspection item.

Inspections without prior notice look directly at physical goods and documents. Among all possible violations, label language is the easiest to discover and the easiest to evidence, because the product stands on the shelf with its label attached. Technical documentation flaws are rarely detected on the spot; the label is exposed evidence. This asymmetry should drive the priority of the labelling workstream above many formally heavier tasks.

The asymmetry also shapes internal audit planning. Labelling should be checked at every artwork revision, because artwork changes are frequent and each one can silently drop a Georgian element from the layout. A one-page artwork checklist covering the Georgian elements catches such drops at proof stage, when correction is free.

4. Practical recommendations

1. Cover at minimum the following label elements: product name, manufacturer name and address, country of origin, expiry date or service life, batch or serial number, storage conditions, and warnings and precautions.
2. Run a back-translation check after translation, having an independent translator render the Georgian text back into English and compare it with the source.
3. Retain the translated files and the translator’s qualification documents before printing, so they can be produced as evidence during inspections.
4. Handle label changes through the change notification process; never swap the packaging first and file the notification afterwards.

5. Verification checklist

• □ The label of the smallest sales unit carries complete Georgian content
• □ The instructions for use are available in a Georgian version
• □ Back-translation verification has been completed and archived
• □ Translated files and translator qualification documents have been retained
• □ Label changes are routed through the change notification process

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Georgian market, from Georgian labelling and back-translation verification to inspection-ready translation archives. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.