Georgia Medical Device Advertising Restrictions under Article 113: Registration Status Determines Claim Boundaries

1. Key takeaways

Georgia imposes explicit restrictions on product claims: Article 11³ (Article 113), paragraph 6 of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, provides that supplementary medicinal products, biologically active additives and para-therapeutic products that are not registered as medicinal products, or not voluntarily registered under the national system, must not claim to treat diseases. The provision establishes the fundamental rule that registration status determines the boundary of what may be claimed. Although the text of Article 11³ is addressed to drug-related categories, its logic reaches medical device marketing practice in two ways: directly, for combination and borderline products that could be presented as drug-adjacent categories; and indirectly, as the interpretive template the authority applies when judging whether any pre-registration claim crosses into therapeutic territory. Marketing materials are also the easiest evidence for inspectors to obtain, which makes this article a practical enforcement risk rather than a theoretical one.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586, August 10, 2009, consolidated version of November 30, 2023: Article 11³ (Article 113) on advertising.
2. Article 11³, paragraph 6: supplementary medicinal products, biologically active additives and para-therapeutic products not registered as medicinal products, or not voluntarily registered under the national system, must not claim to treat diseases.
3. Article 11³, paragraph 7: advertising of medicinal products voluntarily registered under the national system is not subject to the restrictions of this article (except paragraph 5).
4. Article 1, paragraph 3: supplementary medicinal products, biologically active additives and para-therapeutic products are subject to state regulation only when voluntarily registered under the national system.
5. Article 1¹: definition of medical items; Article 11¹⁰, paragraph 6: cancellation and removal from the register.

3. Expert insights

Insight one: the legislative structure of Article 11³ is registration in exchange for the right to advertise. Paragraph 6 prohibits unregistered products from claiming therapeutic effects; paragraph 7 lifts part of the restriction for voluntarily registered products. This pair of provisions ties advertising freedom directly to registration status. For medical devices, the rule that registration status determines the boundary of claims carries general reference value even where the device itself is outside the literal scope: the authority reasoning that applies to unregistered supplements claiming cures is the same reasoning an inspector will apply to a device brochure promising disease treatment before registration is granted.

Insight two: the provision forces the marketing calendar to be bound to the registration timeline. Medical device marketing materials, especially for IVD products and therapeutic devices, naturally involve disease-related statements. Publishing such content before registration is completed falls directly within the prohibition of Article 11³. This is not a theoretical risk: promotional materials are the evidence most easily obtained during inspections, and distributors frequently publish translated brochures without headquarters review, creating exposure the manufacturer did not anticipate.

Insight three: paragraph 6 and Article 1, paragraph 3 close the loop. Article 1, paragraph 3 states that these products are subject to state regulation only when voluntarily registered; paragraph 6 states that without registration there can be no therapeutic claims. The company faces a binary choice: either accept regulation in exchange for the right to advertise, or stay outside regulation and refrain from therapeutic claims. There is no third path of remaining unregistered while advertising freely, and business plans should be stress-tested against exactly that binary.

Insight four: the consolidated version of the law matters for citation practice. The applicable consolidated version of Law No. 1586 is dated November 30, 2023, so contracts, SOPs and training materials should cite the law together with its consolidated version date rather than only the original 2009 date. Article 1¹, which defines medical items, provides the definitional bridge for borderline discussions, and Article 11¹⁰, paragraph 6 supplies the ultimate sanction of cancellation and removal, meaning an advertising violation pursued to its end can end in the loss of the register entry, not merely in an advertising takedown. That linkage converts advertising compliance from a marketing formality into a pillar of the post-market survival strategy.

For multinational portfolios, the practical reading is also a translation question. Claims that are compliant in one jurisdiction, such as general wellness language, can become disease-treatment claims in Georgian translation, where verb forms and phrasing drift toward therapeutic meaning. Reviewing the Georgian text of every brochure, and not only the source language version, is therefore part of the compliance process, and distributors should be contractually barred from translating marketing materials without central approval.

4. Practical recommendations

1. Establish a compliance review process for marketing materials, under which no material containing disease-related statements is released before registration approval.
2. Confine the advertising content of registered products to the intended use stated in the registration file, without extrapolation.
3. Bring exhibition and academic event materials within the same review scope, since oral claims carry the same risk.
4. Sign advertising compliance clauses with local distribution partners, allocating responsibility for violations clearly.
5. Keep dated records of review decisions so the company can demonstrate, if questioned, exactly which materials were cleared and when.
6. Train sales staff annually on the distinction between permissible informational content and prohibited disease-treatment claims, using concrete Georgian and English examples from the company’s own portfolio.
7. Screen digital channels, including websites, social media accounts and online marketplaces operated by or for the company, under the same review process, since inspectors treat published web content like printed materials.

5. Verification checklist

• □ Marketing material compliance review process established
• □ No disease-related statements released before registration approval
• □ Advertising content of registered products kept within the intended use
• □ Exhibition and academic materials included in review scope
• □ Distribution agreements contain advertising compliance and liability clauses
• □ Dated records of review decisions retained
• □ Sales staff training on permissible claims delivered annually
• □ Digital channels included in advertising review scope

Regulatory information verified as of October 30, 2026

This English edition is provided by GRZAN, the international regulatory translation service of the GRZAN global compliance desk. GRZAN translates medical device regulatory guidance for manufacturers, importers and authorized representatives preparing documentation for Eurasian, Caucasian and EU-aligned markets. For translation, regulatory monitoring or compliance support inquiries, contact info@grzanglobal.com.