Georgia Medical Device Registration: Applicant Eligibility and the Interested Person Rule

1. Key takeaways

The threshold for who may file a medical device registration application in Georgia is deliberately low. The qualifying status is that of an interested person, defined in Article 1¹ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: a natural or legal person who is willing to register a product under the recognition procedure or the national procedure. This definition attaches no nationality requirement and no requirement to maintain a local entity, which means a foreign manufacturer can act as the applicant in its own name. The picture changes for clinical trials: under Article 4 of Government Decree No. 386 of October 3, 2023, one of the conditions for conducting a clinical trial is the existence of a legal representative registered in Georgia. Applicant eligibility and liability allocation are therefore two distinct questions: eligibility follows Article 1¹, while accountability for products placed on the market follows Article 4 paragraph 1 point b of Law No. 6157-Iს of May 8, 2012, under which the representative of a foreign manufacturer in Georgia, or the person placing products on the Georgian market where no representative exists, is deemed to be the manufacturer. Foreign manufacturers should treat filing rights and market responsibility as separate workstreams from day one.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, consolidated version of November 30, 2023: Article 1¹ defines an interested person as a natural or legal person willing to register a product under the recognition procedure or the national procedure; the definition carries no nationality or local establishment condition.
2. Article 1¹ also contains the definition of voluntary registration, and Article 1 paragraph 3 provides that supplementary medicines, biologically active additives and paratherapeutic products fall under state supervision only when they are voluntarily registered under the national procedure.
3. Article 11⁴ establishes that marketing authorizations are granted under two procedures, and Article 11¹¹ sets out the application, the registration dossier requirements and the registration fee.
4. Government Decree No. 386 of October 3, 2023, Article 4: clinical trials may be conducted only where, among other conditions, a legal representative registered in Georgia exists.
5. 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 where the foreign manufacturer has no representative, is deemed to be the manufacturer.

3. Expert insights

Insight one: applicant eligibility and the liable entity are two different questions. Article 1¹ answers who may apply, while Article 4 paragraph 1 point b answers who bears responsibility. A foreign manufacturer may file a registration application directly, but if it has no representative in Georgia, the code deems the person who places the products on the market to be the manufacturer, and responsibility attaches to that party. In practice this means the importer or the distributor may be pulled into the liability chain even though it never designed or manufactured the product. Read together, the two provisions form the complete accountability framework Georgia applies to foreign operators: openness at the filing stage, and conduct-based responsibility at the market stage. Companies that treat these two articles as a single package avoid the most common structural mistake in the Georgian market, namely assuming that the right to file implies the absence of any local accountability.

Insight two: the clinical trial track imposes a harder local requirement. Article 4 of Decree No. 386 expressly requires a legal representative registered in Georgia as one of the conditions for conducting a trial. The registration dossier carries no such requirement; clinical trials do. This is the most visible divergence between the two procedures operating in the same market, and it means companies cannot simply carry the applicant arrangement used for registration into a clinical trial programme. Because trial start dates are usually fixed by study protocols and investigator agreements, a missing legal representative registered in Georgia can delay the entire study. Planning the representative appointment as a separate critical-path task, rather than as an annex to the registration file, is the practical consequence of this distinction.

Insight three: the concept of voluntary registration shows that filing is an act of will. Article 1 paragraph 3 builds the supervision of supplementary medicines, biologically active additives and paratherapeutic products on voluntary registration by an interested person under the national procedure. This signals that in Georgia the expression of intent is itself a procedural element: the dossier should state clearly under which procedure registration is sought. That stated choice drives the review track, the registration fee under Article 11¹¹ and the evidence package, so the declaration of intent in the application is not a formality but a decision that shapes the whole procedure.

4. Practical recommendations

1. State in the application that the applicant is an interested person within the meaning of Article 1¹, and identify at filing whether registration is sought under the national procedure or the recognition procedure, since this choice governs review depth, fee and documentation.
2. Where a foreign manufacturer files directly, assess whether a local accountable entity should nevertheless be appointed under Article 4 paragraph 1 point b, so that liability does not fall on channel partners by default, and record the rationale in the market entry file.
3. If clinical trials in Georgia are planned, complete the registration of the legal representative as a separate critical-path workstream, started before dossier assembly rather than after it.
4. In multi-entity scenarios involving a manufacturer, importer and distributor, allocate the roles recorded on the register and the boundaries of liability among the parties through written agreements, and review those agreements whenever the channel structure changes.

5. Verification checklist

• □ The application states the interested person status under Article 1¹ and the chosen registration procedure
• □ The need for a local accountable entity has been assessed and documented
• □ The legal representative for clinical trials has completed registration in Georgia
• □ Liability boundaries among multiple entities have been fixed by written agreements
• □ The source texts of Article 1¹ and Article 4 paragraph 1 point b have 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.