Georgia Classification Letter for Non-Mandatory Medical Devices

1. Key takeaways

A medical device that does not fall into the categories subject to mandatory registration enters Georgia by first obtaining a classification confirmation letter from the competent authority, establishing that the product is not a medicinal product and does not require registration. The legal space for this practice comes from Article 3 paragraph 2 of the Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012: where a specific technical regulation prescribes no detailed safety requirements, the general requirements of the code apply. The confirmation-letter procedure itself is a practical estimate — a matter of industry practice with no explicit statutory basis — so its availability, form, and turnaround must be confirmed with the authority for each project.

The critical message for market-entry planning is that the confirmation letter settles a legal characterisation, not a compliance burden. After the letter is issued, the product remains subject to the general safety obligations of Chapters II and III of the code and to Georgian-language labelling. Reading the letter as an all-clear that removes every obligation is the single most common misunderstanding in Georgian device projects, and it tends to surface as a problem at customs or in distributor negotiations rather than at the authority.

For exporters already holding CE documentation, the confirmation letter is best understood as the entry ticket to a lighter compliance track, not as the whole track itself. The letter answers the characterisation question once; the general safety obligations of the code apply continuously thereafter, and Georgian-language labelling remains a standing duty. Budgeting for the letter alone, without the continuing obligations, produces a market position that looks clean on paper and fails on first inspection.

2. Legal basis

The classification-confirmation practice rests on the following legal materials.

1. Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012: Article 3 paragraph 2 (Chapters II and III apply where no specific technical regulation exists) and Article 3 paragraph 1 (products of listed states placed on the market without restriction).
2. Law of Georgia on Health Care, Law No. 6000 of March 21, 2008: Article 67 paragraph 1 (the ministry, together with relevant state bodies, develops and implements quality and safety standards for medical technique devices and medical technologies).
3. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 1 paragraph 3 (voluntary registration; non-invasive mechanical contraceptive products are not subject to state regulation under that law) and Article 1¹ (definition of medical supplies).
4. DCFTA implementation report of the Government of Georgia, second quarter of 2025, target 3.1.2: alignment with MDR/IVDR and the status of the draft Law on Medical Devices.
5. Practical estimate statement: the name of the confirmation letter, the receiving department, the required documents, and the turnaround time are not stated in any official legal text and derive from established industry practice.

3. Expert insights

Insight 1: the confirmation letter settles legal characterisation, not compliance exemption. Its function is to answer whether the product is a medicinal product and whether registration is required. Once issued, the product still falls under the general safety obligations of Chapters II and III of the Product Safety and Free Movement code and still must satisfy Georgian-language labelling requirements. Treating the letter as a conclusion that nothing needs to be done is the most frequent cognitive error in Georgian projects, and it is usually discovered at the worst possible moment — during a customs check or a distributor audit.

Insight 2: Article 67 paragraph 1 gives the ministry standard-setting power, and the confirmation letter is the case-by-case application of standards. The ministry is responsible for developing quality and safety standards for medical technique devices. Where a product category has no corresponding standard, case-by-case characterisation through a confirmation letter becomes the only workable instrument. This explains why the confirmation letter is so common in Georgia: it is the product of an incomplete standard supply, filling the gap between a general code and categories that no technical regulation yet addresses.

Insight 3: the space available to the confirmation letter will shrink as legislation advances. Target 3.1.2 of the government report shows that MDR/IVDR alignment and a dedicated device law are in progress. Once a dedicated law establishes a comprehensive registration system by risk class, the argument that a product is not a drug and therefore needs no registration will no longer hold. Products currently relying on a confirmation letter need a transition plan for the closure of this channel, including monitoring of the draft law and budgeting for registration under the future regime.

4. Practical recommendations

The following measures make the confirmation-letter route durable while it lasts, and inexpensive to migrate away from when the dedicated device law arrives.

1. State expressly in the application materials the conclusion that the product is not a medicinal product and does not belong to the mandatory registration categories, with the supporting reasoning, and attach a product description and intended use.
2. Seek to have the confirmation letter list the specific models it covers, so the letter does not need to be re-obtained model by model when the portfolio grows or changes.
3. Even with the letter in hand, prepare the full safety evidence package and Georgian-language labelling to the highest applicable standard, so the market position survives scrutiny by distributors, customs, or a future regulator.
4. Maintain a validity ledger for the confirmation letter and re-verify every 12 months that the product characterisation still holds, particularly against progress of the draft device law.

5. Verification checklist

• □ Classification confirmation letter obtained and covering all marketed models
• □ Characterisation conclusion and reasoning archived with the application
• □ Safety evidence package complete (CE or equivalent documents)
• □ Georgian-language labels and instructions for use completed
• □ Annual review mechanism for the confirmation letter established

Regulatory information verified as of October 30, 2026

This English version was prepared by GRZAN for the international medical device registration guide. GRZAN provides regulatory translation, dossier preparation and market-entry support for Georgia and other jurisdictions. Questions about this article may be sent to info@grzanglobal.com.