Georgia Medicines and Pharmaceutical Activities Law 2026: Medical Goods Definition and Device Scope

1. Key takeaways

The Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586 (10 August 20091¹ of its definitions contains an entry for medical goods, a term that describes devices, apparatus, dressings, prosthetic and orthotic products and related items. Through this definitional entry, the registration system of the law can be invoked for certain device categories. The mechanism is definitional rather than substantive: the law does not contain a device-specific regime, but its medicines registration machinery extends to products captured by the medical goods description. For manufacturers, this has a practical consequence that is easy to underestimate. The reasoning chain that justifies any registration obligation for a device must start at the definition, proceed through the registration provisions, and end at the administrative decision of the agency. If the first link is missing, the whole chain collapses. Companies that anchor their regulatory position in the medical goods definition from the first submission onward find that later discussions with the authority proceed on a documented and predictable footing.

The practical reading of the medical goods definition rewards attention to its examples. The list moves from devices and apparatus through instruments and medical equipment to dressings, prostheses and orthopaedic products, which together cover a large share of the hospital supply catalogue. Because the definition is anchored in the purposes of prevention, diagnosis, treatment and patient care, the intended medical use stated in the labelling, rather than the physical form of the product, is often what pulls an item into the definition. Two products with identical construction can therefore sit on opposite sides of the line if their instructions for use make different claims. Manufacturers should review their labelling with this in mind before filing, because the cheapest moment to align claims with the desired classification is before the authority reads the file.

2. Legal basis

1. Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, adopted on 10 August 2009, consolidated version of 30 November 2023, registration code 470.200.000.05.001.000.199.
2. Article 1¹ (definitions): medical goods means 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: definitions of granting a marketing authorisation, of departmental registry, and of interested person, meaning a person willing to register a product under the recognition regime or the national regime.
4. Article 1(3): supplementary medicines, biologically active additives and paratherapeutic products may be voluntarily registered under the national regime.
5. Article 3(3)(a): the agency grants marketing authorisations.

3. Expert insights

Insight 1: this is a medicines law, and medical goods is only the entrance. The primary regulated object of the law is medicines; devices enter its scope of application through the medical goods definition. This explains why devices in Georgia follow the same national regime and recognition regime as medicines, rather than an EU-style risk classification pathway. The consequence is that device dossiers are shaped by pharmaceutical conventions, and reviewers assess them with pharmaceutical expectations in mind. Manufacturers should therefore not transplant MDR-style technical documentation formats without adaptation, but should structure their submissions around the definitions and procedural articles of Law No. 1586 itself, while still presenting the underlying device evidence in a form that is recognisable to an internationally trained reviewer. The pharmaceutical framing also affects the vocabulary of the file. Terms such as presentation, batch and shelf life carry meanings in Law No. 1586 that reviewers will apply even to a device submission, so a glossary that maps device terminology onto the statutory vocabulary of the medicines law avoids low-value clarification rounds. Companies maintaining a global regulatory template should resist the temptation to file the same master document everywhere, and should instead invest in a Georgian-specific mapping annex, which is short, cheap to produce, and consistently effective in reducing the number of deficiency items raised at intake.

Insight 2: the voluntary registration mechanism reveals the limited reach of the law. Article 1(3) provides that supplementary medicines, biologically active additives and paratherapeutic products fall under state supervision only when an interested person voluntarily registers them under the national regime, while non-invasive mechanical contraceptive products are entirely outside state supervision under the law. This voluntary-entry design demonstrates that registration under the law is not universally mandatory, and the mandatory scope for devices must be determined category by category. Reading the voluntary mechanism as a general permission for all devices to register voluntarily is a misinterpretation with real cost: a company that volunteers a product into the regime takes on fees, variation obligations and renewal duties that the category may never have attracted in the first place.

Insight 3: the definition of interested person determines who may apply. The definition limits applicants to natural or legal persons willing to register a product under one of the two regimes, without adding nationality or local entity requirements. This is the legal space in which a foreign manufacturer can apply directly, and it is also the anchor for the discussion of applicant eligibility later in this series. Practical experience nevertheless shows that local representation remains operationally useful for customs, service and recall coordination, even where the law itself does not demand it, so the eligibility analysis should be kept distinct from the commercial decision on local presence.

4. Practical recommendations

1. When citing the law to establish device obligations, anchor first in the medical goods definition of Article 1¹ and only then proceed to the registration provisions, forming a complete reasoning chain.
2. For borderline products such as drug-device combinations and medicated dressings, classify them first against the combination product description of Article 1¹ to avoid taking the wrong channel.
3. State expressly in the application file that the applicant is an interested person within the meaning of Article 1¹ and identify the registration regime chosen.
4. Do not misread the voluntary registration logic as a general option for all devices; the mandatory scope must be judged in combination with the product category.

5. Verification checklist

• □ Confirmed that the product can fall within the medical goods definition of Article 1¹
• □ Excluded classification ambiguity for drug-device combination products
• □ Stated the interested person status expressly in the application file
• □ Specified the choice between the national regime and the recognition regime
• □ Verified the publication date of the consolidated version as 30 November 2023

GRZAN international services — GRZAN provides classification analysis against the medical goods definition, borderline product determination and application strategy under Law No. 1586 of Georgia. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026