Georgia Medical Device Local Representative: Optional for Registration, Unavoidable for Liability

1. Key takeaways

Georgia currently has no EU-style mandatory local authorized representative regime for medical devices. A registration application can be filed directly by a foreign manufacturer as an interested person under Article 1¹ of Law No. 1586 of August 10, 2009. However, Article 4 paragraph 1 point b of Law No. 6157-Iს of May 8, 2012 places liability on the person placing products on the market where no representative exists, and clinical trials require a legal representative registered in Georgia under Article 4 of Government Decree No. 386 of October 3, 2023. The conclusion is compact: registration without a representative is permitted, liability without a representative is unavoidable, and a representative for trials is mandatory. The contrast with the European Union is instructive: Article 11 of Regulation (EU) 2017/745 obliges manufacturers outside the Union to appoint an authorized representative, while Georgia simply lacks a corresponding provision because the dedicated device law has not yet been adopted. The DCFTA implementation report of the Georgian government for the second quarter of 2025, target 3.1.2, tracks MDR/IVDR-aligned technical regulations and the draft law on medical devices, which is exactly where a mandatory representative regime would enter. Companies should not read the current silence as a stable end state. For portfolio planning, the three tracks should be reviewed together at every market entry review, because a decision on one track, such as appointing a representative for a trial, automatically changes the risk position of the other two.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 1¹ definition of an interested person, with no nationality or local entity requirement; Article 11⁴ on the two registration procedures; Article 11¹¹ on applications, dossier requirements and the registration fee.
2. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement: Article 4 paragraph 1 points a, b and c on the three categories of deemed manufacturers.
3. Government Decree No. 386 of October 3, 2023, Article 4: a legal representative registered in Georgia is a condition for conducting clinical trials.
4. Regulation (EU) 2017/745 (MDR), Article 11: manufacturers established outside the European Union must appoint an EU authorized representative, included here as the comparative regime.
5. Georgian government DCFTA implementation report for the second quarter of 2025, target 3.1.2: status of MDR/IVDR-aligned technical regulations and of the draft law on medical devices.

3. Expert insights

Insight one: the absence of a mandatory representative in Georgia is a gap in the system, not a policy choice. Article 11 of the MDR explicitly requires manufacturers outside the European Union to appoint an authorized representative; that is a deliberately designed institution. Georgia has no corresponding provision because the dedicated law on medical devices is still a draft. Once the MDR alignment lands, a mandatory representative regime is very likely to follow, since the draft law tracked under target 3.1.2 of the DCFTA report transposes the European model. A manufacturer that operates today without any local entity is building on a window that will close. Planning for a representative now, on contractual terms the company chooses, is materially cheaper than appointing one later under time pressure when a legal obligation is introduced.

Insight two: not appointing a representative does not mean having no local responsibility. Article 4 paragraph 1 point b deems the person placing products on the Georgian market to be the manufacturer where no representative exists. In practice this pulls the importer or the distributor directly into the liability chain, including for regulatory documentation and safety actions. For a foreign manufacturer this is a form of uncontrolled liability allocation: responsibility lands on a commercial partner whose contract terms the manufacturer may not fully control, and the cost eventually returns to the manufacturer through recourse claims, lost stock and channel friction. The accountable entity will exist in law whether or not the manufacturer chooses one; the only real decision is whether that entity is a party selected and contracted by the manufacturer or whoever happened to import the shipment. The same deemed-manufacturer analysis reaches accessory and component suppliers as well, whose products fall under Article 4 once they are placed on the Georgian market.

Insight three: the mandatory requirement for clinical trials is the only hard constraint today, and it is a rehearsal. Article 4 of Decree No. 386 already writes a legal representative registered in Georgia into the conditions for conducting a trial. This provision demonstrates that Georgian legislators know and accept the instrument of a local accountable entity. It also gives companies a low-cost opportunity to test representative candidates in a controlled setting: a party that performs well as a trial representative is a natural candidate for broader market-facing responsibilities once a general regime arrives. The experience also builds institutional memory on both sides, since the authority becomes familiar with the company structure that will later face the broader regime, and internal teams learn how a Georgian accountable entity operates in practice.

4. Practical recommendations

1. Even where appointment is not mandatory, designate a local accountable entity for commercial placements, so that liability under Article 4 paragraph 1 point b does not fall by default on importers or distributors.
2. Fix liability allocation and recourse mechanisms explicitly in channel agreements, including indemnities and cooperation duties in safety actions, to keep the liability chain controlled.
3. Include the possible future mandatory authorized representative in three-year regulatory planning, and pre-qualify candidate partners before an obligation forces a rushed appointment.
4. For clinical trial projects, complete the registration of the legal representative without exception; no alternative arrangement substitutes for it under Decree No. 386.

5. Verification checklist

• □ The liability exposure of not appointing a local representative has been assessed
• □ Channel agreements define liability allocation and recourse
• □ Three-year planning incorporates the possibility of a mandatory representative regime
• □ The legal representative for clinical trials has completed registration
• □ The gap against Article 11 of the MDR has been evaluated for future readiness

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.