Georgia Medical Device Name and Address Changes: Keeping the Register in Sync

1. Key takeaways

After a change of company name or manufacturing address, the Georgian registration certificate and the departmental register must be updated in parallel, on the legal basis of Article 11⁶ and the change system of Article 11¹¹ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. The compliance weight of a manufacturing address change is higher than that of a name change, because the address can touch the judgment of product conformity. Two mechanisms drive this weight. First, under Article 11⁷, the recognition procedure relies on documents that identify the sameness of the product with the approved product of the reference country, and the production address is one of the compared fields, so an address change weakens the recognition basis itself. Second, under Article 3 paragraph 3 of Law No. 6157-Iს of May 8, 2012, a substantial change of safety characteristics makes the product a new product, and changes involving production processes, premises or equipment migration must be argued item by item. The most common form of non-compliance is a lag between the commercial registry update and the register update, a window in which inspectors operating under Government Decree No. 278 of August 1, 2023 can directly document the mismatch between the register and reality. The risk is therefore not hypothetical but observable, and it attaches to the company, not to the registry office, because the duty to keep records current sits with the certificate holder.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁶ (the departmental register), Article 11¹¹ (type I and type II changes, and the registration dossier requirements).
2. Article 1¹: the definition of an interested person and the definition of the departmental register.
3. Article 11⁷: the recognition procedure relies on documents identifying sameness, and the production address is a compared field of the sameness assessment.
4. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement, Article 3 paragraph 3: a substantial change of safety characteristics makes the product a new product.
5. Government Decree No. 278 of August 1, 2023: the duty to provide documents and explanations to the regulatory authority.

3. Expert insights

Insight one: under the recognition procedure, an address change is a sameness problem. Article 11⁷ makes the recognition track depend on documents that identify sameness with the reference-country approved product, and the production address is a core compared field. Once the address changes, a difference opens between the reference-country approval evidence and the product as filed, and the recognition basis is weakened even if the manufacturing process is untouched. Companies on the recognition procedure should therefore assess this consequence before relocating production, and where the move is unavoidable, should decide early whether the route forward is a change filing or a fresh registration. Discovering the sameness gap after the relocation, when evidence and site no longer match, is the most expensive version of this mistake. Where several products share the relocated site, the assessment should be made per product, since the recognition basis of each certificate weakens independently.

Insight two: Article 3 paragraph 3 supplies the standard for judging whether a change is substantial. The provision deems a product with substantially changed safety characteristics to be a new product. A pure name change clearly does not qualify; a purely administrative address change usually does not; but changes involving production processes, premises or equipment migration require argument item by item, because these factors can genuinely alter safety characteristics. Companies should apply this standard in a documented internal determination, kept in the regulatory file, rather than leaving the judgment implicit. A written determination protects the company in an inspection, and the same document accelerates the external filing because the classification rationale is already drafted. The determination should be signed by both the engineering owner and the regulatory owner, so that neither function can later disown the judgment.

Insight three: the desynchronization of the register and the commercial registry is the most frequent violation. Companies typically complete the commercial registry change first and address the registration documents afterwards, leaving a time gap. During that gap, the register records information that no longer matches reality, and an inspector acting under Decree No. 278 can document the discrepancy on the spot, together with the explanations of the inspected entity. The exposure is avoidable: the same change notification that triggers the commercial registry update should trigger the regulatory change filing on the same day, and the two tracks should be tracked on one checklist so that neither finishes alone. Assigning a named owner to the checklist, with the target dates for all five items, converts the sync from good intention into an auditable commitment.

4. Practical recommendations

1. Maintain a change synchronization checklist covering five items updated together: the commercial registry, the registration certificate, the departmental register, the customs documents and the tender document packages.
2. Before a manufacturing address change, assess both the sameness impact under Article 11⁷ and the new-product risk under Article 3 paragraph 3, and record the conclusions.
3. When filing a name change, attach the notarized and legalized proof of the commercial registry change together with its Georgian translation.
4. After completion, retain the register update evidence and compress the time gap between the commercial change and the register update to the minimum the procedure allows.

5. Verification checklist

• □ All five items of the change synchronization checklist have been updated
• □ The manufacturing address change has been assessed for sameness and new-product risk
• □ The name change filing includes the notarized, legalized registry proof and its Georgian translation
• □ The register update evidence has been retained
• □ The time gap before completion of the update has been minimized

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.