Georgia Medical Device Registration Regimes 2026: Recognition Regime vs National Regime

1. Key takeaways

Georgia offers exactly 2 statutory channels for a marketing authorisation: the recognition regime of state registration and the national regime of state registration, both based on Article 11⁴ of the Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586 (10 August 2009). The two channels differ substantially in review depth, duration and documentation volume, and the pathway choice is the largest cost lever in a Georgian project. The recognition regime substitutes reference-country approval conclusions for local scientific review, while the national regime subjects the product to full administrative and scientific-technical examination. Because the difference between the channels is driven by the evidence a company holds rather than by preference, the pathway analysis must be completed before budgeting, before contracting with local partners and before any submission document is drafted. A project that starts on the wrong channel will either accumulate deficiency letters on the recognition route or pay for duplicated review on the national route, and in both cases the timeline damage is measured in months rather than weeks.

The fee and timeline asymmetry between the channels also shapes contracting. Local distributors and importers frequently price their services on the assumption of one specific channel, and a late switch of pathway can reopen commercial negotiations at the worst moment. For this reason the pathway determination, the budget and the local agreements should be sequenced in that order, with the evidence inventory completed before any contract is signed. Projects that follow this sequence report fewer mid-course renegotiations, because the channel decision is documented, evidence-based and available to all parties before commitments are made, rather than being discovered during dossier preparation when positions have already hardened.

2. Legal basis

1. Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, adopted on 10 August 2009, consolidated version of 30 November 2023.
2. Article 11⁴ (frequently displayed as Article 114 on database pages): marketing authorisations are granted under the recognition regime and the national regime.
3. Article 11⁵ (Article 115), paragraph 1: the period of validity of a marketing authorisation is determined under the recognition regime and the national regime.
4. Article 11⁷ (Article 117): state registration under the recognition regime for medicines, governing the document on identification of sameness, the period of validity of registration, suspension and revocation.
5. Article 11¹¹ (Article 1111): state registration under the national regime for medicines, governing applications, administrative and scientific-technical review, re-registration, Type I and Type II variations, period of validity, documentation requirements, registration fees, suspension and revocation.
6. Article 11⁶ (Article 116), paragraphs 4 and 5: entry in the departmental registry under the recognition regime or after completion of the procedure under Article 11¹¹.

3. Expert insights

Insight 1: the difference between the two channels is not speed, but whether a scientific review is repeated. The core of the recognition regime is the document on identification of sameness, which uses the approval conclusion already completed in a reference country to replace local scientific review. The national regime, by contrast, requires full administrative review followed by scientific-technical review. Products holding reference-country approval evidence should therefore take the recognition regime as the first option, while products without such evidence can only take the national regime. The choice is determined by evidence, not by preference. Companies sometimes attempt to argue a product into the recognition route using partial or non-equivalent approvals, and this approach reliably fails at the sameness identification stage, so the honest evidence inventory should be the very first deliverable of the project. When assembling that inventory, distinguish between approvals that are themselves reference conclusions and approvals that merely cite another authority. Sameness identification works on the primary decision, so a national approval that relied on a reliance procedure in its own reference country should be traced back to the originating authority before the document on identification of sameness is drafted. The extra tracing step is short, and it prevents the most common rejection ground on the recognition route.

Insight 2: Article 11¹¹ writes registration fees into the statute itself. The article expressly enumerates the documentation requirements and the registration fee, which shows that fees are a statutory element of the national regime. The recognition regime is governed separately, outside that article, and the two fee structures cannot be simply mapped onto each other. Budget owners should treat the two routes as two distinct fee schedules and should never extrapolate a quote obtained for one regime to the other. Where a project may switch channels mid-course, for example because reference-country evidence matures later than planned, the budget should carry both fee scenarios from the start.

Insight 3: variation types at the statutory level are only two tiers. Article 11¹¹ lists Type I and Type II variations, while the industry usage of Type IA and Type IB is a further subdivision of Type I, a practical estimate rather than a statutory category. When grading a change, companies should first apply the two-tier statutory framework and then prepare the documentation according to the practical subdivision. This two-step discipline matters in correspondence: a submission that announces only a Type IA grading without demonstrating where it sits inside the statutory Type I category invites a deficiency question about the legal basis of the grading itself, which delays the change far longer than the extra paragraph of reasoning would have.

4. Practical recommendations

1. Make the inventory of reference-country approval evidence the first task of the project, and determine the channel on that basis.
2. Organise the recognition regime dossier around the sameness storyline, explaining every local difference, such as labelling, language and presentation, individually.
3. Bind the national regime dossier in two parts matching the administrative review and the scientific-technical review of Article 11¹¹, to enable stage-by-stage deficiency responses.
4. Grade variations first under the two statutory tiers, then prepare the documentation according to the practical subdivision, and state the grading rationale in the submission.

5. Verification checklist

• □ Inventoried the reference-country approval evidence and determined the channel
• □ Organised the dossier storyline according to the selected channel
• □ Split the national regime dossier into administrative and scientific-technical volumes
• □ Documented the two-tier grading rationale for variations
• □ Calculated the registration fees and included them in the budget

GRZAN international services — GRZAN manages pathway selection between the recognition and national regimes, sameness documentation and variation grading for manufacturers entering Georgia. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026