Georgia Medical Device Market Entry Budget Model: Timelines, Fees and Staffing

1. Key takeaways

A market entry budget for Georgia should be modeled along three lines: timeline, fees and staffing. The timeline line runs through 8 procedural stages, with the national procedure taking about 2 months and the recognition procedure about 1 month, both figures being practical estimates rather than statutory durations. The fee line follows the three segments of official fee, legalization and translation, and agency services, with Article 11¹¹ of Law No. 1586 of August 10, 2009 as the statutory source of the registration fee. The staffing line allocates 3 roles: a regulatory role, a translation role and a local liaison role. The modeling order matters: the registration pathway is chosen first, because the choice between the recognition procedure and the national procedure determines both the magnitude of the timeline and whether technical review occurs at all. Where products carry measuring functions, Article 67 paragraph 2 of the Law on Health Care No. 6000 of March 21, 2008 adds a type-approval branch that must be budgeted as a parallel line, not discovered late. and should hold the 500 GEL fee only as a marked practical estimate. All stage durations, rates and staffing ratios are practical estimates drawn from filing experience and are not fixed in any official provision. The model should exist as a simple spreadsheet with one row per stage, so that every recalibration updates a number rather than a narrative.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁴ (the two procedures), Article 11⁷ (the recognition procedure), Article 11¹¹ (the national procedure and the registration fee), Article 11⁶ (the register), Article 11⁵ (period of validity).
2. Government Decree No. 386 of October 3, 2023, Article 4: document and proof-of-payment requirements, and the requirement of notarized Georgian translations.
3. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement, Article 3 paragraph 1.
4. Law of Georgia on Health Care No. 6000 of March 21, 2008, Article 67 paragraph 2: type approval as an additional stage.
5. Practical estimate statement: the number of days per stage, the rates and the staffing ratios are stated in no official legal provision and derive from filing experience.

3. Expert insights

Insight one: the first variable of the model is the pathway, not the product. The choice between the recognition procedure and the national procedure determines the scale of the timeline line and whether technical review happens at all, so it moves the budget more than any product attribute. Treating product complexity as the first variable produces directional errors: a complex product with complete CE evidence can move faster under the recognition procedure than a simple product that lacks evidence from a reference country. The correct sequence is to classify the available reference-country evidence first, fix the pathway second, and only then let product characteristics influence the dossier line. Budget reviews that start from the pathway consistently produce shorter correction loops than reviews that start from the product specification. A written pathway decision, with the evidence basis for it, should be the first deliverable of every Georgian project.

Insight two: the legalization chain is the only cost item unaffected by product complexity and driven purely by document volume. No matter how simple the product is, the power of attorney, the manufacturer declarations and the translations of key dossier pages must pass every legalization and notarization step. As a result, small projects carry a higher share of unit cost on this line, because the fixed per-document cost is spread over a small total. This is the structural reason why small product lines in Georgia often lose money: the official fee is modest, but the legalization chain consumes the margin. Consolidating filings by model family and reusing legalized originals across variants are the two levers that directly attack this cost concentration. Where originals can lawfully be reused, their cost becomes a one-time investment rather than a recurring per-filing charge.

Insight three: type approval is the hidden branch of the model. Article 67 paragraph 2 of Law No. 6000 adds an independent stage for products with measuring functions. The model should treat the presence of a measuring function as a boolean switch: when it is triggered, a parallel branch with its own stage, documents and budget opens, rather than the cost appearing as a late surprise. Because measuring functions frequently appear across accessory items as well as main devices, the switch should be evaluated for every stock-keeping unit, not only for the headline product, and the branch budget should be visible in the approved baseline. Flagging the branch at quotation stage also prevents scope disputes with service providers, because the extra stage is priced before the contract is signed rather than added afterwards.

4. Practical recommendations

1. Build the model in the order: fix the pathway first, then lay out the 8 stages, then overlay the legalization chain, and finally add the type-approval branch where measuring functions are present.
2. Add a 30 percent buffer to all externally committed timelines, and set internal stage milestones tracked weekly against actual progress.
3. For small product lines, complete model-family consolidation before modeling, to dilute the unit cost of the legalization chain across variants.
4. Recalibrate the model parameters quarterly against actual project data, so the organization builds its own internal baseline instead of relying on external folklore figures.

5. Verification checklist

• □ The model has been built in the order of pathway, stages, legalization chain and type-approval branch
• □ External timeline commitments carry a 30 percent buffer
• □ Internal stage milestones have been set and are tracked weekly
• □ Model-family consolidation has been completed
• □ The quarterly recalibration mechanism for model parameters has been established

Regulatory information verified as of October 30, 2026

This English edition of the GRZAN international regulatory guide is published by GRZAN for informational purposes only. GRZAN supports manufacturers, importers and distributors with regulatory strategy, registration filings, local representative coordination, labeling review and import compliance for Georgia and other markets. For questions about this article or tailored regulatory support, contact info@grzanglobal.com.