Georgia National Market Surveillance Strategy under Article 3(1): Law No. 1447 and the 4-Year Cycle

1. Key takeaways

Article 3¹ of the Code of Georgia on Product Safety and Free Movement, the national market surveillance strategy provision, was added by Law No. 1447 of April 1, 2026 of Georgia and entered into force on June 1, 2026. The article requires the Ministry of Economy and Sustainable Development to prepare a national market surveillance strategy at least once every 4 years, defining the priorities, objectives and tasks of market surveillance policy for products in regulated areas. This is the latest-effective and most certain regulatory change in this topic: unlike the device statute still in draft, the strategy obligation is already binding law with a fixed text, a named ministry and a defined cycle. For device companies the provision matters because it determines where inspection resources will be concentrated next, and because the first strategy document, once published, becomes the single most informative public signal about enforcement focus in Georgia.

2. Legal basis

1. Code of Georgia on Product Safety and Free Movement, Law No. 6157-Iს, May 8, 2012: Article 3¹ on the national market surveillance strategy.
2. Article 3¹, paragraph 1: the national market surveillance strategy defines the priorities, objectives and tasks of market surveillance policy for products in regulated areas, and sets out the methods for achieving the established objectives and tasks.
3. Article 3¹, paragraph 2: the Ministry of Economy and Sustainable Development of Georgia prepares the national market surveillance strategy at least once every 4 years.
4. Amending law: Law No. 1447 of April 1, 2026 of Georgia (website, 3.4.2026); effective date June 1, 2026.
5. Government Resolution No. 278 of August 1, 2023 of Georgia: the concrete enforcement tools and inspection powers.
6. Government DCFTA implementation report of Georgia (second quarter of 2025), target 3.1.1: a strategy for alignment in the fields of standards, conformity assessment, accreditation, metrology and market surveillance; an interagency working group established by ministerial order on April 17, 2025.

3. Expert insights

Insight one: Article 3¹ is empirical proof that the enforcement side is tightening ahead of the legislative side. The Georgian device-specific statute and the MDR alignment technical regulations are still in progress, yet the market surveillance strategy provision has already entered into force and obliges the ministry to prepare strategies on a cycle. Enforcement capability building is running ahead of legislation, and companies cannot use the absence of a device law as an explanation for post-market non-compliance. The correct planning assumption is that inspections under Resolution No. 278 continue at full intensity while the strategic layer matures around them.

Insight two: the priority-setting character of the strategy means enforcement resources will be concentrated, not spread evenly. Paragraph 1 explicitly requires the strategy to define priorities, which signals that surveillance will not be uniform but focused on the fields the strategy identifies. Companies should track the strategy text actively and point their compliance resources at the fields designated as priorities; this is the evidence-based way to spend compliance money where inspection probability is highest, rather than spreading it evenly across low-risk areas.

Insight three: the 4-year cycle gives companies a predictable planning window. Paragraph 2 requires preparation at least once every 4 years, which gives the strategy stability and predictability. Companies can plan compliance investments on the strategy cycle instead of reacting to scattered enforcement actions, aligning budgeting, audits and supplier controls to the same rhythm that the regulator itself will follow.

Insight four: the two DCFTA reference points frame the strategy within a broader alignment program. The government DCFTA implementation report of the second quarter of 2025 records, under target 3.1.1, the development of an alignment strategy in the fields of standards, conformity assessment, accreditation, metrology and market surveillance, and notes that an interagency working group was established by ministerial order on April 17, 2025. The Article 3¹ strategy obligation and the target 3.1.1 work are two layers of the same effort: the former is binding domestic law with a fixed cycle, the latter is the political commitment machinery that feeds it. Companies monitoring both will see enforcement priorities earlier than companies reading either source alone.

The relationship between the strategy layer and the tool layer also deserves precision. Article 3¹ does not itself create inspection powers; those rest in Resolution No. 278. What Article 3¹ does is determine where those powers will be aimed, on a 4-year rhythm, with published priorities. For a medical device company the actionable consequence is to read the first strategy document, once published, as a map of inspection probability across product categories and distribution channels, and to time its own audit calendar so that internal audits precede, rather than follow, the areas flagged as priorities.

4. Practical recommendations

1. List the national market surveillance strategy text as a mandatory tracked document and complete an impact assessment for the company’s products within 30 days of its publication.
2. Read the strategy alongside the enforcement tools of Resolution No. 278 to judge which inspections are most likely to reach the company.
3. Adjust the compliance budget allocation according to the priority fields of the strategy, increasing investment in high-priority areas.
4. Align the 4-year strategy cycle with the company’s three-year compliance planning baseline.
5. Assign a named owner for strategy monitoring so that the 30-day impact assessment obligation has an accountable holder from day one.
6. Map the company’s own product categories against the fields named in target 3.1.1, standards, conformity assessment, accreditation, metrology and market surveillance, so that each future priority designation can be translated immediately into concrete internal actions.
7. Schedule internal audits so that they precede, rather than follow, the publication of each strategy document, using the draft priorities as the audit scope.

5. Verification checklist

• □ National market surveillance strategy text listed as a mandatory tracked document
• □ 30-day post-publication impact assessment mechanism established
• □ Cross-analysis against the enforcement tools of Resolution No. 278 completed
• □ Compliance budget adjusted according to strategy priority fields
• □ Three-year plan aligned with the 4-year strategy cycle
• □ Named owner assigned for strategy monitoring

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.