Georgia Definition of Medical Device 2026: Two Parallel Legal Terms and Classification Strategy

1. Key takeaways

The Georgian legal sources contain no unified definition of the term medical device. Instead, they describe the object through 2 parallel terms: Chapter VIII of the Health Care Law uses medical technical devices, and Article 1¹ of the Law of Georgia on Medicines and Pharmaceutical Activities uses medical goods. The two terms have different reaches, and the difference determines whether a product is governed by lifecycle supervision or by the registration system. Neither term is the translation of a European definition, and neither carries a risk classification scheme attached to it. For a manufacturer, this means that the question of what the product legally is in Georgia cannot be answered by pointing at an MDR category or an FDA class. It must be answered by mapping the product against two domestic definitions in sequence, and by accepting that a product can sit inside one term while sitting outside the other. Getting this mapping done early, and documenting it, is what prevents the most common Georgian market entry surprise, which is a product assumed to be out of scope discovering its obligations only at the border.

A useful way to operationalise the two terms is to treat them as answering different questions. The medical technical devices term of the Health Care Law answers the question of what the state supervises across the life of the product, while the medical goods term of the medicines law answers the question of what must pass through registration. A product can be a medical technical device without being a medical good subject to registration, and the classification confirmation letter exists precisely to document such outcomes. Compliance planning should therefore produce two conclusions per product, one per term, each with its own citation, instead of a single verdict that blurs the two questions together.

2. Legal basis

1. Law of Georgia on Health Care, Law No. 6000, adopted on 21 March 2008: Chapter VIII is titled 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: Article 1¹ definition of medical goods, meaning goods used in medical practice for the prevention, diagnosis and treatment of diseases and for patient care, for example devices, apparatus, instruments, medical equipment, dressings, prostheses and orthopaedic products.
3. Article 1¹ definition of radioactive medicines and diagnostic medical products: products with ionising radiation properties and/or chemical products used in medical practice.
4. Article 1¹ definition of combined advanced therapy medicinal products, point c.d: products containing one or more medical devices, or one or more active implantable medical devices, forming an integral part of the medicinal product.
5. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს, dated 8 May 2012: Article 4(1) definition of product.

3. Expert insights

Insight 1: the enumerative definition of medical goods determines the elasticity of the registration scope. The definition opens with the words for example and then lists devices, apparatus, instruments, medical equipment, dressings, prostheses and orthopaedic products, which makes it an open-ended enumeration. This leaves the authority room for discretion on specific categories, and it also explains why the categories actually subject to mandatory registration, such as dental materials and testing systems, do not fully coincide with the reach of the definition. Open-ended definitions cut both ways: they allow reasonable extension to new product technologies, but they also create classification uncertainty at the margin. Companies with novel or hybrid products should therefore budget time for a classification dialogue with the authority rather than assuming that the enumeration either includes or excludes their product on its face. In documentation practice, the safest posture is dual anchoring: describe the product so that it clearly satisfies the core elements of the definition that matter for the chosen pathway, while avoiding claims that needlessly stretch the enumeration toward categories where the practice of the authority is unsettled. Product descriptions written for other markets often overstate indications or functions in marketing language, and such language, transplanted into a Georgian submission, can widen the classification dispute unnecessarily.

Insight 2: drug-device combination products are handled under the medicines law in Georgia. Article 1¹ point c.d places combined advanced therapy medicinal products containing devices directly under the definition of biological medicines, showing that Georgia adopts a medicines-led classification approach for combination products, which differs from the EU reasoning based on the primary mode of action. Combination product manufacturers should prepare the master file along the medicines pathway. The practical consequence is significant for documentation strategy: the pharmaceutical part drives the procedural route, the review sequence and the variation logic, while the device component is presented as an integral element of the medicinal product rather than as an independently authorised item.

Insight 3: the product definition of the Code is the outermost fallback. Article 4(1) defines a product as all movable property and related services, even where the item is a component of another movable or of immovable property. Where a device falls neither within the term medical technical devices nor triggers the registration system, it is still subject, as a product, to the general safety obligations of Chapters II and III of the Code. This is the third layer of obligation that many companies overlook. Even a fully deregulated accessory therefore carries documentary duties in Georgia, and its safety assessment, instructions and traceability should be engineered to Code standards from the first shipment.

4. Practical recommendations

1. In submission documents, state both the medical technical devices attribute and the medical goods attribute of the product, covering the terminology of both laws.
2. Prepare the master file for combination products along the medicines-led pathway and describe the mode of action of the device component separately.
3. For devices outside the registration scope, still perform the general safety obligations under Article 3(2) of the Code and retain safety assessment records.
4. Unify the internal glossary on the term medical device, but annotate the original statutory wording at each legal citation to avoid translation ambiguity.

5. Verification checklist

• □ Confirmed that the product satisfies the description of both terms
• □ Combination product classified along the medicines-led pathway
• □ General safety obligations of the Code performed for non-registered devices
• □ Internal glossary unified and annotated with the statutory wording
• □ Authentic text of Article 1¹ and Chapter VIII archived

GRZAN international services — GRZAN delivers product definition mapping against the parallel Georgian terms, combination product classification strategy and three-layer obligation analysis. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026