Georgia Medical Device Compliance Roadmap 2026-2028: Enforcement First, Legislation Follows

1. Key takeaways

The compliance mainline for Georgia in 2026 through 2028 is enforcement first, legislation follows: the market surveillance strategy provision entered into force on June 1, 2026, while the MDR/IVDR alignment technical regulations and the Law on Medical Devices are still in progress. A company’s three-year roadmap should be built around 3 anchors: preserving the existing register status, pre-building technical documentation to the MDR structure, and tracking the legislation so that a gap assessment is completed within 30 days of promulgation. The sequencing is not arbitrary; it follows the observable legislative rhythm of the past three years, in which enforcement instruments matured first and structural statutes followed. Companies that invert the order, waiting for the device statute before fixing post-market basics, will face both an active inspection regime and a reform deadline at the same time.

2. Legal basis

1. Government DCFTA implementation report of Georgia (second quarter of 2025), target 3.1.1: an interagency working group established by ministerial order on April 17, 2025 to develop a strategy for alignment in the fields of standards, conformity assessment, accreditation, metrology and market surveillance.
2. Same report, target 3.1.2: adoption of technical regulations compliant with (EU) 2017/745 and (EU) 2017/746; the draft Law on Medical Devices has been prepared by the Ministry of Health.
3. Same report, target 3.1.4: preparation of amendments to the Code on Product Safety and Free Movement in accordance with (EU) 2019/1020 (internal consultation stage).
4. Code of Georgia on Product Safety and Free Movement, Law No. 6157-Iს (May 8, 2012), Article 3¹: added by Law No. 1447 of April 1, 2026, effective June 1, 2026.
5. Government Resolution No. 278 of August 1, 2023 of Georgia; Government Resolution No. 386 of October 3, 2023 of Georgia.
6. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 (August 10, 2009), Articles 11⁴, 11⁵, 11⁶, 11⁷, 11¹⁰ and 11¹¹; Law of Georgia on Healthcare, Law No. 6000 (March 21, 2008), Articles 66 and 67.

3. Expert insights

Insight one: in the three-year roadmap the first year is about holding, the second and third about building. In 2026 the enforcement conditions are already in place, with Article 3¹ in force and Resolution No. 278 in hand, so the primary task is to preserve the existing register status and withstand inspections. In 2027 and 2028, as the technical regulations and the device statute land, the focus shifts to rebuilding technical documentation and the registration portfolio under the new rules. Resources, hiring and consultant budgets should follow this hold-then-build curve rather than being spread flat across the three years.

Insight two: the code amendments under target 3.1.4 will further strengthen market surveillance. Once the amendments prepared in accordance with (EU) 2019/1020 are adopted, the legal basis of market surveillance upgrades from the current provisions to an EU-benchmarked market surveillance framework. This is the second enforcement-side change after Article 3¹, and companies should begin tracking it within 2026, since it will shape authority powers, data exchanges and possibly economic operator obligations well before the device statute is debated in its final form.

Insight three: within the three-year window, early movers face lower conversion costs. Products entering now on the basis of classification letters or narrow-scope registrations will need re-evaluation once the statute lands; companies that prepare technical documentation to the MDR structure from the start will only need to complete localization items at that point. On a three-year horizon this cost difference becomes very significant, and it compounds with inspection exposure in the interim, since well-documented products also withstand unannounced inspections better.

Insight four: the breadth of the cited statutory base shows why a single-owner governance model works. The roadmap rests on Law No. 1586 in six articles, from 11⁴ through 11¹¹, on Articles 66 and 67 of Law No. 6000, on two government resolutions and on the Article 3¹ strategy layer, together with three DCFTA targets, 3.1.1, 3.1.2 and 3.1.4. No single person absorbs that spread naturally; the workable answer is one named owner with a quarterly cadence, a shared tracker, and a rule that every cited instrument in the baseline library carries its verification date. That structure converts a fragmented legal landscape into a manageable calendar without requiring the company to maintain in-country counsel for routine updates.

The target 3.1.4 amendments deserve a specific note in the plan. Preparing amendments to the code in accordance with (EU) 2019/1020, currently at the internal consultation stage, signals that the market surveillance framework will eventually cover economic operator duties, data exchange between authorities and possibly extended powers over products presenting risks. Companies that map their current distribution chains, storage locations and responsible-entity arrangements against the EU 2019/1020 concepts in advance will read the Georgian amendments faster than competitors and will need fewer structural changes when they arrive.

4. Practical recommendations

1. Make legislative monitoring a fixed quarterly agenda, covering the government resolution and law sections of matsne.
2. Score the compliance health of all products on sale once a year; products scoring below the threshold enter the remediation list.
3. Sign agreements with the local responsible entity for a term of 3 years, covering this legislative cycle.
4. Maintain an internal regulatory baseline library, updating the version and date after every verification.

5. Verification checklist

• □ Three-year roadmap decomposed into hold in 2026, build in 2027, reorganize in 2028
• □ Legislative monitoring set as a fixed quarterly agenda
• □ Annual compliance health scoring mechanism established
• □ Local responsible entity agreements cover the 3-year legislative cycle
• □ Internal regulatory baseline library established and updated by verification date
• □ Remediation list process defined for below-threshold products

Regulatory information verified as of October 30, 2026

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