Georgia Medical Device Licence Transfer: Holder Changes and Departmental Register Updates

1. Key takeaways

When the holder of a Georgian registration certificate changes, the legal landing point is an information change in the departmental register, and the legal source is Article 11⁶ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. The change must be processed in the register in parallel with the transaction, because completing the commercial registry change alone is not sufficient to preserve the validity of the registration. Georgian law separates the private agreement from the public record: a transfer contract binds the two parties, but for third parties and for the regulator the register entry is the visible legal position. The register is maintained by the institution under Article 3 paragraph 3 point c, and its format and preservation procedure are approved by the state under Article 3 paragraph 2 point c, so a holder change takes effect only through the institutional procedure. Article 11¹¹ distinguishes type I and type II changes, which determines the workload of the filing, and Article 11¹⁰ paragraph 6 empowers the institution to revoke a registration and remove it from the register, which is the sanction a delayed holder change risks. Planning the register update as a closing condition of the transaction is therefore the central recommendation of this article. Since the register also feeds customs and tender workflows, a stale entry spreads the disruption well beyond the registry itself.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁶ (entry in and maintenance of the departmental register), Article 1¹ (definition of the departmental register and of an interested person).
2. Article 3 paragraph 2 point c: the format and preservation procedure of state-approved departmental registers; Article 3 paragraph 3 point c: the institution maintains the departmental register.
3. Article 11¹¹: type I and type II changes, and the registration dossier requirements.
4. Article 11¹⁰ paragraph 6: the institution may revoke a registration and remove it from the departmental register.
5. Government Decree No. 278 of August 1, 2023: the regulatory authority may require inspected entities to provide documents and explanations.

3. Expert insights

Insight one: the effect of a holder change comes from the register, not from the contract. A transfer agreement is valid between the parties, but toward third parties and the regulator the register entry is the operative legal appearance. Article 11⁶ and Article 3 paragraph 3 point c together establish the institutional authority over the register, so the change must pass through the institution to become effective. In an acquisition or a portfolio transfer, this means the deal documents alone deliver no regulatory effect: until the register reflects the new holder, customs questions, tender participation and authority correspondence all run against the old entity. Teams should therefore sequence the register update inside the closing calendar, not after it, and should treat the updated register extract as the deliverable that proves completion. Where multiple certificates transfer in one transaction, the filings should be tracked per certificate, because a single laggard record can hold up the closing condition for the whole deal.

Insight two: the classification of the change determines the workload. Article 11¹¹ distinguishes type I and type II changes, and a change of certificate holder involves a replacement of the accountable entity, which may require treatment at the higher level depending on whether the change affects the judgment of the safety and performance of the product. The filing should state the classification rationale and the basis in Article 11¹¹ explicitly, because an unexplained classification invites deficiency rounds that lengthen the timeline. Preparing the reasoning alongside the dossier, rather than answering it reactively, keeps the change on the shortest available track and signals regulatory competence to the reviewing institution. Where the classification is genuinely uncertain, a short pre-filing clarification to the institution costs less than a full deficiency round later.

Insight three: the revocation risk of Article 11¹⁰ paragraph 6 is the price of delaying the change. Where the holder has changed and the register has long not been updated, the institution can revoke the registration on the ground of inaccurate information and remove the record. This is more serious than a fine, because removal strips the product of its right to be legally sold in Georgia, and rebuilding the registration afterwards means a fresh procedure with fresh fees and fresh timelines. The sanction converts holder-change diligence from an administrative chore into a material transaction risk, which is why deal lawyers and regulatory teams should jointly own this workstream in any transfer involving Georgian certificates. A dated register extract obtained at signing and again at closing documents exactly when the change became visible to the regulator.

4. Practical recommendations

1. Start the register change immediately once the transaction structure is fixed, and make the completed register update one of the precedent conditions of the deal closing.
2. Assemble the change file with four elements: the legal documents of transfer or succession, qualification evidence of the old and the new holder, the updated power of attorney, and a declaration of product consistency.
3. State the classification of the change with its basis in Article 11¹¹ in the filing, and attach an index of the original registration documents.
4. After completion, obtain the register update evidence, and synchronize the customs and tender document packages with the new holder data before the next shipment or bid.

5. Verification checklist

• □ The register change has been listed as a precedent condition of the transaction closing
• □ The four elements of the change file are complete
• □ The classification of the change states its basis in Article 11¹¹
• □ The register update evidence has been obtained
• □ The customs and tender document packages have been synchronized

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.