Georgia First Registration Timeline: Eight Steps and Practical Estimates

1. Key takeaways

A first registration in Georgia can be broken down, according to established industry practice, into 8 steps: document collection; confirmation of the application form and letter of intent; finalisation of the dossier and submission of samples; receipt of the review invoice and initiation of payment; administrative review; technical review; entry in the sectoral registry; and issuance of the registration order and licence certificate. Under the practical estimate, the national regime takes approximately 2 months and the recognition regime approximately 1 month; no statutory review deadline exists in the legal text, so both figures are planning values rather than legal entitlements.

Because no statutory deadline anchors the total duration, project control must operate at the level of steps rather than the level of a promised total. Each of the 8 steps can be assigned an owner, a completion criterion, and an internal milestone, and slippage can be detected where it happens instead of being discovered when the overall schedule has already failed. This step-level discipline is the practical substitute for the missing statutory clock.

The sequence also has a documentation logic that applicants can exploit. Steps one to three — collection, form confirmation, dossier finalisation with samples — are entirely within the manufacturer’s control, while steps five to seven belong to the authority. Compressing the manufacturer-controlled steps and keeping the payment approval ahead of the invoice converts the 8-step chain into a pipeline where the only true waiting time is the authority’s own review, which is the minimum achievable duration under any reading of the process.

2. Legal basis

The procedural sequence rests on the following provisions.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11¹¹ (administrative and scientific-technical review, registration fees), Article 11⁷ (recognition regime), Article 11⁶ (entry in the sectoral registry).
2. Article 11⁵ paragraph 1: the validity of a marketing authorisation is determined under the two regimes.
3. Article 12 paragraph 2: manufacture of unregistered products for registration purposes is permitted, which supports the sample preparation step.
4. Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012, Article 2 paragraph 3: products manufactured in conformity with the European Union approach directives satisfy the essential safety requirements of the code.
5. Practical estimate statement: the 8-step breakdown, the approximately 2-month and 1-month durations, and the payment triggered by invoice before review are not stated in any official legal text and derive from established industry practice and filing experience.

Because the procedural detail lives in practice rather than in the statute, the invoice-triggered payment and the exact document forms required at each step should be confirmed with the local representative or the authority before the project plan is frozen.

3. Expert insights

Insight 1: receipt of the review invoice and initiation of payment is a distinctive step of the Georgian process. The settlement of review fees occurs before the review starts and is triggered by an invoice rather than scheduled by the applicant. Payment therefore functions as a front gate of the process, not as a back-office formality, and a delayed approval workflow inside the finance department will freeze the entire project. Moving payment approval to the document-preparation stage is the cheapest schedule-compression action available in a Georgian project, because it removes a full step from the critical path without touching the dossier itself.

Insight 2: the timeline figures lack a statutory review deadline, so management must run on step durations instead of a total period. Since Article 11¹¹ fixes no specific review term, the 2-month figure is an experience value. When scheduling, manufacturers should set internal milestones for each of the 8 steps with owners and completion criteria, rather than committing externally to a total number of days. External commitments built on an experience value convert a planning uncertainty into a contractual liability.

Insight 3: entry in the registry and issuance of the certificate are two separate steps, and a time gap exists between them. Article 11⁶ governs the conditions of entry, while the registration order and licence certificate are issued separately. Customs clearance and tender participation may require different documents at different points in that gap. Sales and logistics teams should confirm, step by step, which document form is available at each moment, so that a tender deadline does not collide with the interval between registry entry and certificate issuance.

4. Practical recommendations

The following measures keep the 8-step sequence moving without idle intervals.

1. Complete the payment approval during the document-preparation stage, so the project never stalls at the invoice step waiting for an internal signature chain.
2. Set internal milestones for each of the 8 steps, with a named owner and a written completion criterion for every step, and review the milestones at a fixed cadence.
3. Start sample preparation early under Article 12 paragraph 2, running it in parallel with dossier preparation instead of sequencing samples after submission.
4. When committing timelines externally, add a 30 percent buffer and state expressly that the figures are a practical estimate rather than a statutory review deadline, so counterparties plan on the same assumption.
5. Keep copies of the invoice, the payment receipt, and the registration order together in one project file, since customs and tender processes may request any of the three at different moments.

The commonest schedule failures in Georgian first registrations are administrative rather than technical: a late payment approval, a missing notarised translation, or a sample lot held back until after submission. Each of these failures lives in the manufacturer-controlled half of the sequence, and each is preventable with the checklist discipline described above.

5. Verification checklist

• □ Milestones for all 8 steps scheduled with named owners
• □ Payment approval completed during the preparation stage
• □ Sample production started under Article 12 paragraph 2
• □ Document forms needed for customs and tenders confirmed per step
• □ External commitments buffered and marked as a practical estimate

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.