Georgia Medical Device Regulatory Framework 2026: Three-Law Structure and Compliance Action Plan

1. Key takeaways

Georgia, as of October 30, 2026, has no standalone medical device law. The current regulatory regime operates through a combination of 3 laws and several government resolutions: the Law of Georgia on Health Care governs the entire device lifecycle, the Law of Georgia on Medicines and Pharmaceutical Activities governs the registration system, and the Product Safety and Free Movement Code of Georgia governs market access and market surveillance. For a manufacturer preparing to enter this market, the first step is not to choose a registration pathway, but to determine whether the product falls into the categories that are managed along the medicinal product pathway. This three-law structure means that a single product may simultaneously attract lifecycle obligations, registration obligations, and general product safety obligations, each arising from a different legal source. Companies that map only one of the three laws into their compliance plan will inevitably discover gaps at the worst possible moment, such as during a customs clearance check or a tender submission. The strategic direction of reform is nonetheless clear: Georgia is aligning toward Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and a draft Law on Medical Devices has already been prepared by the responsible ministry, so every compliance decision taken today should be reviewed against the future MDR-style framework.

2. Legal basis

1. Law of Georgia on Health Care, Law No. 6000, adopted on 21 March 2008, published as LHG I, No 9, 4.4.2008, Art. 75; Chapter VIII on Medical Technical Devices and Medical Technology, Article 66 and Article 67.
2. Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, adopted on 10 August 2009, consolidated version published on 30 November 2023; Article 11⁴ (frequently displayed as Article 114 on database pages).
3. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს, dated 8 May 2012; Article 2 and Article 3.
4. DCFTA implementation report of the Government of Georgia (second quarter of 2025, dcfta.gov.ge), target 3.1.2: in order to align with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, the draft Law of Georgia on Medical Devices has been drafted by the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs.

3. Expert insights

Insight 1: the absence of a dedicated law does not mean the absence of regulation. The opposite is true. Georgia has divided medical devices into three segments and legislated for each of them separately. The lifecycle belongs to Chapter VIII of the Health Care Law, market access authorisation borrows the registration system of the medicines law, and product safety is backstopped by the Product Safety and Free Movement Code. When preparing a dossier, a manufacturer must satisfy three distinct legal logics at the same time. Preparing documentation according to only one of them, for example treating the project as a pure registration exercise modelled on another jurisdiction, will leave lifecycle obligations under the Health Care Law and general safety obligations under the Code unaddressed. This structural observation is the single most important planning input for any Georgia market entry project, because it determines which documents must exist before the first submission and which obligations continue after authorisation is granted.

Insight 2: the legislative status can be evidenced by government reporting. In its DCFTA implementation report, the Georgian government lists technical regulations adopted as an output indicator under target 3.1.2, and the implementation column records that the draft law has been completed. This statement sits in tension with the assessment in European Commission report SWD(2023) 31, which records that Georgia has adopted legislation aimed at achieving full alignment with the EU acquis in the relevant fields. The former is a self-reported deliverable awaiting completion, while the latter is an evaluation of existing legislation. The position of GRZAN is to confirm the direction from the latter and the current state from the former: the direction is MDR and IVDR alignment, while the current state is that the dedicated law has not yet been enacted. Treating the two sources as interchangeable is a common analytical error that produces either premature compliance spending or false confidence in the status quo.

Insight 3: the legal significance of CE marking derives from the Code, not from the registration system. Article 2(3) of the Product Safety and Free Movement Code provides that products manufactured in conformity with the European new approach directives and the global approach directives are deemed to satisfy the essential safety requirements of the Code. This makes a CE certificate the basis of a presumption of safety, not a voucher exempting a product from registration. The two lines must not be conflated: a device may carry a valid CE mark and still require registration in Georgia if it falls within a category managed along the medicinal product pathway, and conversely a non-registered device may still need to demonstrate conformity with the Code when no technical regulation applies.

4. Practical recommendations

1. Before project initiation, perform a category triage: determine whether the product belongs to the categories managed along the medicinal product pathway, such as dental materials, testing systems, reagents and allergens; products outside these categories proceed through the classification confirmation pathway.
2. Prepare documentation using a three-law cross-check list, mapping each dossier element against Article 66 and Article 67 of the Health Care Law, the registration provisions of the Medicines and Pharmaceutical Activities Law, and Article 2 and Article 3 of the Product Safety and Free Movement Code.
3. Maintain a legislative monitoring log and track matsne.gov.ge monthly for any new technical regulation on medical devices or for the enactment of the Law on Medical Devices.
4. For products already placed on the EU market, prepare the CE evidence package and localised labelling in parallel, so that the remediation cycle is shortened once the dedicated legislation enters into force and transitional requirements are announced.

5. Verification checklist

• □ Confirmed whether the product falls within the registration categories managed along the medicinal product pathway
• □ Obtained and archived the authentic text of Chapter VIII of Law No. 6000
• □ Obtained the authentic text of Article 11⁴ of Law No. 1586 and compared it with the form displayed in the database
• □ Confirmed that the CE certificate is on file and within its period of validity
• □ Established the legislative monitoring log and assigned a responsible owner

GRZAN international services — GRZAN supports manufacturers entering Georgia and other emerging markets with regulatory strategy, category triage and classification confirmation, dossier preparation under the recognition and national regimes, and post-market compliance monitoring against the evolving legislative pipeline. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026