Georgia Medical Device Import Clearance: Certificates, Classification Letters and the Country List

1. Key takeaways

Two documents do different jobs at Georgian import clearance. A registration certificate proves that the product has completed registration under the national or recognition procedure and has been entered in the departmental register, the legal foundation being Article 11⁶ of Law No. 1586 of August 10, 2009. A classification confirmation letter proves that a product is not a medicine and is not subject to registration, which covers accessories, spare parts and borderline items that fall outside the drug framework. Both documents operate against the backdrop of Article 3 paragraph 1 of Law No. 6157-Iს of May 8, 2012, under which products produced in countries included on the government list circulate on the market without restrictions. The practical consequence is that clearance readiness is a package, not a single sheet: the certificate or the classification letter, evidence that the country of origin is on the current list, and, for products with measuring functions, separate type-approval documentation under Article 67 paragraph 2 of the Law on Health Care No. 6000 of March 21, 2008. Specific clearance documentation demands and inspection rates at the border are not stated in any official legal provision and reflect common industry practice as a practical estimate.

2. Legal basis

1. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement: Article 3 paragraph 1 (products produced in listed countries under their domestic law are placed on the market without restrictions; the country list is determined by the government of Georgia), Article 3 paragraph 2, and Article 3 paragraph 3 (a substantial change of safety characteristics makes the product a new product).
2. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁶ (entry in the departmental register), Article 11⁵ (period of validity), Article 1¹ (definition of medical products).
3. Law of Georgia on Health Care No. 6000 of March 21, 2008, Article 67 paragraph 2: type approval of measuring instruments, the register, import and production are carried out as provided by law.
4. Government Decree No. 278 of August 1, 2023: control powers of the regulatory authority in the field of medical and pharmaceutical activity.
5. Practical estimate statement: the specific document demands and inspection rates at clearance are not stated in official legal provisions and derive from common industry practice.

3. Expert insights

Insight one: the unrestricted circulation of Article 3 paragraph 1 is conditional, and the condition is the country list. The provision delegates determination of the list to the government of Georgia, and products from countries outside the list cannot rely on unrestricted circulation. For logistics and clearance planning this means the first verification item is whether the country of origin appears on the current list, not whether the product carries a foreign approval. Companies should archive the version of the list they relied on and the date of the check, because list updates between production and arrival can change the legal basis of a shipment that is already in transit. Treating the country check as a standing element of the import file, renewed for every consignment, converts a latent clearance risk into routine documentation. It also creates a dated evidence trail: if the list changes between dispatch and arrival, the archived version shows which rule the company relied on when it shipped.

Insight two: Article 3 paragraph 3 turns a modification into a new product. The provision states that where a product within the regulated field undergoes a substantial change of safety characteristics, it is deemed a new product, and placing it on the market or putting it into service requires compliance with technical regulations. This means that an apparently ordinary design change can invalidate the existing clearance basis: the certificate and the register entry describe the old product, while the goods at the border are legally new. Change control and clearance documentation must therefore be linked processes. Any engineering change should pass an assessment against Article 3 paragraph 3 before the modified units are shipped, and the outcome of that assessment should be recorded in the regulatory file, so that the reasoning is available if customs questions the basis of the shipment.

Insight three: Article 67 paragraph 2 writes type approval directly into the import stage. The provision states that type approval of measuring instruments, entry in the register, import and production are carried out as provided by law. For products with measuring functions, customs and inspection authorities may therefore request type-approval evidence in addition to the registration certificate, and a certificate alone does not cover this requirement. Companies should treat the type-approval file as a standing element of the shipping set, prepared once and attached to every consignment, so that clearance never depends on an ad-hoc search for documents that should already be in the file. Device lines that include thermometers, blood pressure monitors, infusion devices or other measuring equipment should treat type approval as a separate documentation track rather than an annex to the certificate.

4. Practical recommendations

1. Build a structured import document package by product category: for registered categories, the registration certificate plus the register search record; for non-registered categories, the classification confirmation letter plus safety evidence.
2. Verify for every shipment whether the country of origin is on the current government list, and archive the list version together with the date of the check.
3. Assess every design change against Article 3 paragraph 3 before shipping; where the change is substantial and the product is deemed new, rebuild the clearance basis before dispatch.
4. For products with measuring functions, prepare type-approval evidence as a separate document and ship it together with the registration certificate in the consignment file.

5. Verification checklist

• □ The import document package has been configured by product category
• □ The country of origin list status has been verified and archived
• □ Design changes have been assessed for the new-product trigger of Article 3 paragraph 3
• □ Type-approval evidence for products with measuring functions is complete
• □ Clearance documents match the records in the departmental register

Regulatory information verified as of October 30, 2026

This English edition of the GRZAN international regulatory guide is published by GRZAN for informational purposes only. GRZAN supports manufacturers, importers and distributors with regulatory strategy, registration filings, local representative coordination, labeling review and import compliance for Georgia and other markets. For questions about this article or tailored regulatory support, contact info@grzanglobal.com.