Georgia Medical Device Penalties: Fines, Suspension and Registration Revocation in Three Tiers

1. Key takeaways

The consequences of medical device non-compliance in Georgia fall into 3 tiers: fines, suspension of activity, and cancellation of registration with removal from the sectoral register. According to industry public sources, the fine for violating medical activity permit conditions reaches up to 5 000 GEL and the fine for violating license conditions up to 15 000 GEL (pending verification against the original text; treated as a practical estimate); the legal basis for cancellation of registration is explicit: Article 11¹⁰, paragraph 6 of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. The tiered structure matters for risk planning because the tiers differ not only in severity but in reversibility: a fine is paid and closed, a suspension is time-limited with statutory restoration mechanics, but a cancellation extinguishes the legal basis for marketing the product and requires a new registration cycle to undo.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586, August 10, 2009: Article 11¹⁰, paragraph 6 (cancellation of registration and removal from the sectoral register), Article 11¹¹ (suspension and cancellation of registration) and Article 11³ (advertising restrictions).
2. Government Resolution No. 278 of August 1, 2023 of Georgia: the regulatory authority may impose administrative fines, suspend the rights, licenses or permits of high-risk medical institutions, and take other decisions provided by law.
3. Law of Georgia on Healthcare, Law No. 6000 (March 21, 2008), Article 63², relevant procedural rules: where medical activity is suspended in full or in part, the institution must apply to the court for approval within 24 hours; a late application is invalid and the right of operation is restored; after the violation is corrected, rights, licenses or permits are restored within 5 working days from the date of application.
4. Code of Georgia on Product Safety and Free Movement, Law No. 6157-Iს (May 8, 2012), Article 1 and Article 3¹.
5. Practical estimate statement: the fine amounts of 5 000 GEL and 15 000 GEL, reports of fines of 2 000 to 4 000 GEL for sale of unregistered products, and confiscation of goods are not found in any statutory text verified for this topic; they derive from secondary public sources and the latest position of the competent authority must prevail.

3. Expert insights

Insight one: the fine is not the heaviest consequence; cancellation of the register entry is. Cancellation and removal under Article 11¹⁰, paragraph 6 directly terminate the legal basis for selling the product in Georgia. When assessing violation risk, a company must not calculate only fine amounts; it should model loss of market access as the worst case, including the downstream costs of refunding tenders, compensating distributors and repeating the registration cycle, which typically dwarfs any administrative fine.

Insight two: Law No. 6000 builds procedural protections around suspension. A suspension of high-risk medical activity must be submitted to the court for approval within 24 hours; if the application is late it is invalid and the right of operation is restored; after the violation is corrected, rights are restored within 5 working days of the application. These deadlines are protective provisions for the regulated party; they place administrative power inside a time cage. Companies should memorize both numbers and invoke them when facing a suspension, since procedural defects can be as effective as substantive defenses.

Insight three: Resolution No. 278 and Law No. 6000 form a substantive-plus-procedural pairing. The resolution confers substantive dispositions, namely fines and suspension; the law imposes procedural constraints, namely the 24-hour court application and the 5-working-day restoration. When responding to an alleged violation, both tracks deserve attention in parallel. A company that argues only the substance while missing the 24-hour window gives up rights that the legislature deliberately granted.

Insight four: the practical estimate status of the amounts calls for a two-column budget approach. Because the figures of 5 000 GEL and 15 000 GEL, and the reported range of 2 000 to 4 000 GEL for sale of unregistered products, come from secondary sources rather than verified statutory text, the finance plan should carry two columns: a provision calculated on the practical estimate amounts, and a legal reserve for the scenario in which the verified figures, once published in the original text, differ materially. The same caution applies to confiscation of goods, which is reported by secondary sources but not confirmed for this topic; where stock value is high, the potential confiscation exposure, not the fine, may dominate the financial model of a violation.

The Product Safety and Free Movement Code completes the framework from the general side: Article 1 states the purposes of protection of life and health and the free movement of safe products, and Article 3¹ anchors the strategy layer that directs surveillance priorities. For a device company the practical conclusion is that penalties can arrive through two doors, the sectoral regime of the drugs and pharmaceutical activity law and the general product safety regime of the code, and the response plan must work for both, including which counsel to call and which internal functions to convene within the first day.

4. Practical recommendations

1. Maintain a violation risk register with separate response plans for each of the three tiers: fines, suspension and cancellation.
2. When a suspension decision is received, verify immediately whether the authority applied to the court within 24 hours; if not, assert restoration of the right of operation.
3. After correcting a violation, apply actively for restoration within the 5-working-day window and retain proof of application and acceptance.
4. Budget reserve amounts for fines at the practical estimate levels, and confirm the applicable provisions for each specific case through a formal legal opinion.
5. Track the competent authority’s published positions quarterly, since the practical estimate amounts may be superseded at any time by verified statutory figures.

5. Verification checklist

• □ Violation risk register established across the three tiers
• □ 24-hour court application deadline built into suspension response plans
• □ 5-working-day restoration application procedure documented
• □ Fine budget reserve set at practical estimate levels
• □ Applicable provisions confirmed by legal opinion for each case
• □ Authority positions monitored quarterly

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.