Georgia Medical Device Pathway Decision Tree: Recognition or National Registration

1. Key takeaways

The choice of a premarket pathway in Georgia is decided by a single question: whether the product holds evidence of a completed approval from a reference country. If such evidence exists, the recognition regime under Article 11⁷ of Law No. 1586 applies; if it does not, the national regime under Article 11¹¹ of the same law applies. The two-regime framework itself is established by Article 11⁴. The pathway therefore cannot be selected at will by the applicant — it is determined by the evidence that the manufacturer can present on the day of filing. A submission built on the wrong pathway is not merely slower; it invites formality objections that restart the procedural clock and consume budget that was planned for review, not for repair.

The practical consequence is that dossier architecture follows evidence rather than preference. Under the recognition regime, the central exhibit is the same-product identification comparison against the reference-country approval. Under the national regime, the dossier must be organised for administrative review and scientific-technical review in sequence, because Article 11¹¹ structures the procedure in exactly those two stages. Both pathways end at the same destination — entry in the sectoral registry under Article 11⁶. Because the endpoint is identical, manufacturers should compare only the cost of arrival: the recognition regime saves the scientific review, while the national regime pays for a complete review of the product itself. Reading the two regimes as competing options misstates the law; they are conditional branches.

2. Legal basis

The pathway framework rests on the following provisions of Georgian law.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, consolidated version of November 30, 2023.
2. Article 11⁴: marketing authorisations are granted under the recognition regime and under the national regime, which together form the statutory framework for all premarket pathways.
3. Article 11⁷ (Article 117): national registration under the recognition regime — same-product identification documents, validity of registration, suspension and revocation.
4. Article 11¹¹ (Article 1111): national registration under the national regime — application, administrative review, scientific-technical review, re-registration, Type I and Type II variations, validity of registration, documentation requirements, registration fees, suspension and revocation.
5. Article 11⁶, paragraphs 4 and 5: the conditions for entry in the sectoral registry under the recognition regime and under the national regime respectively.
6. Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012, Article 3 paragraph 1: products of states included in the statutory list may be placed on the market without restriction.

3. Expert insights

Insight 1: the first branch of the decision tree is same-product evidence, not risk class. Georgia currently has no statutory design that splits medical device pathways by device risk class. The split between pathways originates in the two registration regimes of the drug law, which were written for medicinal products and then extended to the categories of products that fall under mandatory registration. This is fundamentally different from the European Union logic, where Class I devices proceed on a self-declaration while Class III devices face notified body assessment. Teams that apply European experience directly to Georgia will reach the wrong pathway conclusion, because the Georgian gate question is evidentiary rather than classification-based.

Insight 2: the sameness requirement of the recognition regime is a full-chain comparison. Article 11⁷ uses the term same-product identification documents, which requires the applicant to demonstrate that the product filed in Georgia is the same product that was approved in the reference country. Any difference in model, specification, manufacturer name, or manufacturing site must be argued separately and supported on its own terms. This makes the comparison table the core document of a recognition dossier. A comparison table that lists the models but stays silent on the production site, or that treats specification deltas as negligible without justification, converts a straightforward recognition file into a source of objections.

Insight 3: both pathways converge on the sectoral registry, so the real comparison is the cost of arrival. Article 11⁶ paragraphs 4 and 5 set out the entry conditions for the recognition regime and the national regime respectively. Since the legal endpoint is the same registry entry, manufacturers choosing between pathways should not ask which regime sounds preferable in the abstract. They should ask how much review burden each route actually removes or imposes. The recognition regime waives the scientific-technical review but demands complete sameness evidence; the national regime accepts the product as filed but prices that acceptance in a full two-stage review under Article 11¹¹.

4. Practical recommendations

The following actions convert the pathway logic into an operable project routine.

1. Run the decision tree with three questions: does the product fall into a category subject to mandatory registration; does reference-country approval evidence exist; and can that evidence cover the exact models and the manufacturing site named in the Georgian application. Only after all three answers are documented should the regime be declared in the filing.
2. Organise the recognition dossier around the comparison table as its backbone. Write every difference — model, specification, manufacturer, production site — as a standalone explanatory paragraph with its own supporting evidence, so reviewers can verify item by item without reconstructing the comparison themselves.
3. Bind the national-regime dossier in two volumes that mirror the two-stage structure of Article 11¹¹. Keep the administrative volume and the scientific-technical volume separately paginated, so that administrative deficiencies can be corrected without disturbing the technical file and vice versa.
4. For products whose evidence is incomplete but nearly complete, complete the evidence first and file afterwards. Forcing an under-evidenced product through the national regime does not create a shortcut; it converts an evidence gap into a review finding.

5. Verification checklist

• □ Confirmed that the product falls into a category subject to mandatory registration
• □ Reference-country approval evidence inventoried and sameness assessed
• □ Dossier backbone organised according to the selected pathway
• □ Model and manufacturer differences argued item by item
• □ Selected regime and its justification stated expressly in the application

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.