Georgia Medical Device Registration Fees: Official Fees, Legalization and Agency Cost Structure

1. Key takeaways

The cost of registering a medical device in Georgia consists of three components: the official registration fee, the cost of document legalization and translation, and the cost of local agency and professional services. Only the registration fee has a statutory basis: Article 11¹¹ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, expressly lists the registration fee among the elements of national registration. The figure of 500 GEL circulating in the industry is a practical estimate; it appears in no official legal provision and should be confirmed against the current project quotation. The other two components are contractual and volume-driven: legalization and translation costs grow with the number of documents, and agency costs grow with project complexity. Under Article 4 of Government Decree No. 386 of October 3, 2023, the application and the proof of payment of the registration fee are mandatory dossier documents, which means the fee is paid before review, not after approval. Budgeting should therefore treat the official fee as a fixed, non-negotiable line item, concentrate optimization effort on the translation and agency lines, and hold the 500 GEL figure only as a marked practical estimate. The three-segment structure also maps cleanly onto procurement: each segment has a different vendor, a different currency exposure and a different timing, so a single blended cost line hides exactly the information a finance team needs for approval.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11¹¹, national registration under the national procedure, including the registration fee and the registration dossier requirements.
2. Article 11⁷: national registration under the recognition procedure.
3. Article 11⁵ paragraph 1: the period of validity of a marketing authorization is determined under the two procedures.
4. Government Decree No. 386 of October 3, 2023, Article 4: the application and the proof of payment of the registration fee are mandatory documents; the power of attorney requires legalization or consular authentication and notarization; the protocol and the informed consent documents require notarized Georgian translations.
5. Practical estimate statement: the 500 GEL fee figure, notarized translation unit prices and agency service rates are stated in no official legal provision, derive from common industry practice and must follow the project quotation.

3. Expert insights

Insight one: Article 11¹¹ writes the registration fee into statute, which makes the rate a matter of law rather than negotiation. The fee provision sits alongside the dossier requirements, which shows that payment is a procedural requirement, not an administrative detail: without the proof of payment the file is incomplete. Companies should therefore treat the official fee in the budget as a fixed item with no optimization potential, and should direct all cost-reduction work to the translation and agency lines, where scope, language pairs and document volume genuinely move the total. Presenting the fee internally as statutory also protects the project plan from procurement processes that attempt to renegotiate it.

Insight two: the proof-of-payment requirement of Decree No. 386 shows that payment precedes review. The application and the proof of payment of the registration fee are listed side by side as mandatory documents, which is consistent with the practical flow in which payment is initiated on the basis of the review invoice. In budget management this means the fee must be available at project launch, not settled as a tail payment after approval. Cash planning should mark the fee as a launch-stage outflow, and the approval milestone should carry no expectation that the fee is still outstanding. Teams that miss this sequencing create avoidable start delays when the file sits incomplete pending payment confirmation. The proof should therefore be generated, checked against the fee reference in the application and archived in the dossier index the same day payment is made.

Insight three: translation and legalization costs are the systematically underestimated line. Decree No. 386 requires notarized Georgian translations of the protocol and informed consent, and the power of attorney must be provided in original with legalization or consular authentication and notarization. Together these form a four-step chain: original document, legalization or consular authentication, notarization, certified Georgian translation. Every step carries cost and none can be compressed. Because the chain scales with document count, product lines with many models see this cost grow linearly, and it can overtake the official fee entirely on large lines. Modeling the chain per model family, before quotation, is therefore a planning requirement rather than an accounting afterthought. It also gives negotiating leverage: once the chain is visible document by document, the agency scope can be fixed in writing, and unit prices can be benchmarked across providers instead of accepted as a single opaque lump sum.

4. Practical recommendations

1. Build the budget in three segments: the official fee as a statutory fixed item, legalization and translation growing linearly with document volume, and agency services scaled by project complexity.
2. Hold the fee in GEL and reserve room for exchange-rate movement, converting at the rate of the actual payment date rather than the budget date.
3. File product lines consolidated by model family, to reduce duplicated translation and notarization costs across variants that share documents.
4. State in every contract whether each fee item includes tax and whether re-submission rounds after deficiency notices are covered, to prevent late additions to the budget. Each of the three segments should be identified separately in the contract, because a blended quotation makes it impossible to see which items are statutory, which scale with volume and which depend on the provider.

5. Verification checklist

• □ The budget has been built in the three segments of official fee, legalization and translation, and agency services
• □ The official fee is held in GEL with an exchange-rate reserve
• □ The product line has been consolidated by model family for filing
• □ Contracts state the tax treatment and the coverage of re-submission rounds
• □ The 500 GEL figure is marked as a practical estimate throughout the documentation

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.