Georgia Medical Device Registration Scope 2026: Mandatory Categories and Classification Confirmation Letters

1. Key takeaways

Not all medical devices in Georgia require registration. According to prevailing industry practice, described here as a practical estimate, the categories that must be registered along the medicinal product pathway concentrate in dental materials, testing systems organised by disease area, allergens, clinical biochemistry and clinical chemistry reagents, sera, and mechanical contraceptive devices. All other devices require a classification confirmation letter from the competent authority before import and placement on the market, confirming that the product is not a medicinal product and does not require registration. This structural feature makes Georgia one of the lightest registration environments among the markets of the region, but it also means that the critical compliance work shifts from dossier writing to scope determination. A company that correctly sorts its portfolio at the start avoids both failure modes: registering products that never needed registration, and shipping products that needed a confirmation letter and are stopped at customs for lacking one.

The two groups also differ in evidence discipline. For registered categories, the dossier is the compliance object, and its maintenance schedule follows the registration. For confirmation letter categories, the compliance object is the letter itself plus the general safety evidence of the Code, and the letter is tied to the exact models and manufacturer named on it. Portfolio changes such as model extensions, brand transfers or specification revisions therefore have different administrative consequences depending on the group, and the determination conclusion should be revisited whenever any of those changes occurs, not only at project start.

2. Legal basis

1. Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, adopted on 10 August 2009: Article 11⁴ on the two registration regimes and Article 1¹ on the medical goods definition.
2. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს, dated 8 May 2012: Article 3(2) on the application of the general requirements of Chapters II and III where a technical regulation establishes no specific safety requirements.
3. Law of Georgia on Health Care, Law No. 6000, adopted on 21 March 2008: Article 67(1) on the ministry developing standards.
4. DCFTA implementation report of the Government of Georgia, second quarter of 2025, target 3.1.2: the status of the MDR and IVDR alignment technical regulations and of the draft Law on Medical Devices.
5. Practical estimate statement: the list of categories subject to mandatory registration, as well as the procedure and duration of the classification confirmation letter, are not expressly provided in official provisions; they derive from prevailing industry practice and submission experience and must be confirmed case by case with the competent authority.

3. Expert insights

Insight 1: the narrow mandatory scope is the largest structural feature of the Georgian market. Unlike the EU model, which covers all devices by risk class, Georgia concentrates mandatory registration on a small set of categories and releases the remaining devices through the classification confirmation letter. This substantially lowers the entry threshold for a large volume of low and medium risk devices, and it also means that the answer to the question of whether registration is needed is, in Georgia, frequently no. The narrowness should nevertheless not be mistaken for simplicity: the determination of whether a product belongs to the registered categories is itself an exercise requiring care, because the categories are defined by practice rather than by statute, and borderline formulations such as reagents for clinical chemistry invite exactly the kind of interpretation differences that only an authority confirmation can settle. A pragmatic method is to sort the portfolio in three passes: first the clearly registered categories, then the clearly out-of-scope products, and only then the residual borderline items, which should be submitted individually for confirmation. This sequencing concentrates the authority dialogue on the small set of products where it genuinely matters, keeps fees predictable, and gives the commercial team a release date for the majority of the portfolio long before the borderline questions are resolved.

Insight 2: the classification confirmation letter is an administrative confirmation, not a licence. Its function is to confirm that the product is not a medicinal product and does not need to follow the registration procedure; it does not itself confer a right to sell. The legality of selling still depends on the general requirements of Article 3 of the Product Safety and Free Movement Code and on the labelling language requirements. Treating the confirmation letter as a blanket safe-conduct is a common misreading. The letter answers one question only, and the remaining questions of safety conformity, Georgian language labelling and distribution documentation must each be answered on their own legal basis, which is why experienced entrants assemble the confirmation letter and the Code compliance evidence into a single import package.

Insight 3: this configuration is transitional. Target 3.1.2 of the government report shows that the technical regulations aligning with MDR and IVDR and the draft Law on Medical Devices are advancing. Once they are enacted, an EU-style configuration of comprehensive registration by risk class will replace the current narrow-scope registration, and the application space of the classification confirmation letter will be substantially compressed. Products currently released on a confirmation letter will need to be re-evaluated at that point. Companies should therefore read the confirmation letter as a present-day facilitation measure with a known expiry tendency, and should design their technical files so that the transition to a registration dossier does not require reconstruction from zero.

4. Practical recommendations

1. At project initiation, perform the category determination first, assigning the product to one of two groups, requiring registration or requiring a confirmation letter, and archive the determination conclusion.
2. For products on the confirmation letter pathway, prepare CE or equivalent safety evidence in parallel, in anticipation of a possible tightening of the practical estimate.
3. Ensure the confirmation letter names the product model and the manufacturer, and file a new application when models are extended rather than reusing the existing letter.
4. Re-check the legislative progress every 6 months, and start a registration assessment immediately once the dedicated law is adopted.

5. Verification checklist

• □ Category determination completed and the product assigned to registration or confirmation letter
• □ Determination conclusion and its rationale archived
• □ Confirmation letter covering all models on sale
• □ CE or equivalent safety evidence prepared
• □ Legislative progress re-check mechanism set at every 6 months

GRZAN international services — GRZAN performs category determination for the Georgian market, secures classification confirmation letters and maintains legislative monitoring for manufacturers. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026