Georgia Medical Device Legal Representative: Status, Duties and Clinical Trial Requirements

1. Key takeaways

The statutory position of the legal representative in Georgia rests on clear written law. Article 4 of Government Decree No. 386 of October 3, 2023 provides that one of the conditions for conducting a medical device clinical trial is the existence of a legal representative registered in Georgia. The liability positioning of that representative is consistent with Article 4 paragraph 1 point b of Law No. 6157-Iს of May 8, 2012 on product safety and free movement: the representative of a foreign manufacturer in Georgia is the entity that assumes responsibility for the products. The representative is therefore not a courier address or a mailbox, but the local anchor of both trial approval and product accountability. In the trial context the same decree also requires a power of attorney from the sponsor in original form with legalization or consular authentication and notarization, and a copy of a document confirming that trial risks and liabilities are covered. Companies entering the Georgian market with any clinical programme should treat the appointment and registration of the legal representative as the first contractual and administrative task of the project, not as a downstream formality.

2. Legal basis

1. Government Decree No. 386 of October 3, 2023, Article 4: the conditions for conducting a clinical trial include a registration certificate issued by the institution, a positive opinion of the local ethics committee, a legal representative registered in Georgia, and protection of the rights of vulnerable groups.
2. Document requirements under the same article: a power of attorney from the sponsor (original / legalization or consular authentication / notarization) and a copy of a document confirming that trial risks and liabilities are covered.
3. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement: Article 4 paragraph 1 point b, the representative of a foreign manufacturer in Georgia and/or the person placing products on the Georgian market; Article 4 paragraph 1 point c, a person who supplies products to the market within the scope of its activity and whose activity may affect the safety characteristics of the product.
4. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 1¹ definition of an interested person and Article 11¹¹ on applications, dossier requirements and the registration fee.
5. Government Decree No. 278 of August 1, 2023: the supervisory authority may require inspected entities to provide documents, copies and explanations.

3. Expert insights

Insight one: Decree No. 386 formulates the legal representative as a condition, not a suggestion. The provision lists the representative among the conditions for conducting a clinical trial, and without this entity the procedure cannot start. This is the most explicit localization requirement applied to foreign entities anywhere in current Georgian legislation on medical products, and it signals how the future law on medical devices is likely to be drafted. Legislators who have once written a registered legal representative into a decree on clinical trials have already accepted the tool; extending it to registration and market surveillance in a dedicated device law would be a consistent step. Companies should therefore read the current decree not as an isolated trial rule but as a preview of the direction of regulation, and should build representative arrangements that can survive a future extension of the model.

Insight two: the three categories of Article 4 paragraph 1 of the code form a liability chain. Point a covers manufacturers of finished products and of components; point b covers the representative of a foreign manufacturer, or the person placing products on the market when no representative exists; point c covers persons who supply products to the market within their activity and whose activity can affect safety characteristics. The legal representative falls under point b, while a distributor may fall under point c. This shows that Georgian liability design allocates responsibility by conduct rather than by the nature of the entity: what a party does with the product, not what it calls itself, determines whether it is treated as the manufacturer. A distributor that repackages, relabels or otherwise influences safety characteristics moves toward point c, and contracts should anticipate that shift.

Insight three: the document confirming that risks and liabilities are covered makes the representative liability concrete. Decree No. 386 requires the submission of a copy of such a document, which in substance demands that the responsibility has an enforceable carrier, typically an insurance policy or an equivalent arrangement. When appointing a legal representative, the sponsor should therefore confirm not only administrative availability but also whether the candidate has the capacity and the willingness to carry this responsibility. A representative without coverage turns the decree requirement into a paper promise, and the missing document can stall trial approval at the institution.

4. Practical recommendations

1. When appointing a legal representative, conclude a written responsibility agreement that defines the scope of liability under Article 4 paragraph 1 point b and the recourse mechanism between the parties, including what happens after a recall or a field safety action.
2. In clinical trial projects, launch the registration of the legal representative as the first-priority task, before the dossier is complete, because the trial cannot start without it.
3. Arrange the liability coverage, whether insurance or an equivalent instrument, in parallel with the representative appointment, and retain the certificates as part of the trial master file.
4. Review the continuing existence and good standing of the legal representative at fixed intervals, since deregistration or a change of the representative interrupts the continuity of both ongoing trials and registration-related communications.

5. Verification checklist

• □ A written responsibility agreement with the legal representative has been concluded
• □ For clinical trial scenarios, the registration of the legal representative has been started as a priority
• □ The document confirming risk and liability coverage has been obtained and retained
• □ A review mechanism for the continuing existence of the legal representative has been established
• □ The source text of Article 4 of Decree No. 386 has been archived

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.