Georgia Medical Device Document Legalisation: Apostille, Consular Certification and Notarised Translation

1. Key takeaways

Foreign documents entering a Georgian submission follow a legalisation chain of 4 steps: original issuance, apostille or consular certification, notarisation, and a notarised Georgian translation. The written basis of this chain is Government Decree No. 386 of 3 October 2023, Article 4, which requires the sponsor’s power of attorney to be submitted as an original, apostilled or consularly certified, and notarised, and requires other documents to be accompanied by notarised Georgian translations.

Two features of the chain deserve emphasis. First, the choice between apostille and consular certification is not free; it is determined by whether the issuing country is a member of the Hague Apostille Convention. Scheduling must begin with that confirmation, because taking the wrong certification route can invalidate the entire document set and force a restart. Second, the final step, notarised Georgian translation, must be completed locally, its duration cannot be compressed, and it depends on local translator resources. It should be managed as an independent critical path of the project.

Although the decree enumerates its requirements in the context of clinical trial documents, using the same four-step standard for the registration dossier is the most stable strategy available, because no dedicated written rule for registration documents lists the legalisation methods item by item.

Each step of the chain has its own timing logic. Original issuance depends on the document issuer and cannot be accelerated. Apostille is a single certificate attached by the designated authority of the issuing country and is usually fast, while consular certification involves the consulate and follows that consulate’s own schedule. Notarisation is normally bundled with the preceding step in the issuing country. The Georgian translation happens last and locally, and it must be scheduled against the availability of qualified translators. Starting the translation early is cheap insurance: send the stable source documents to translators as soon as their content is fixed, instead of waiting for the whole set.

2. Legal basis

1. Government Decree No. 386 of 3 October 2023 of Georgia, Article 4: the power of attorney issued by the sponsor must be an original, apostilled or consularly certified, and notarised by a foreign notary; the clinical trial protocol and informed consent documents must carry notarised Georgian translations.
2. The same article: the application and the registration fee payment receipt, preclinical trial materials, the CRF, a copy of the documents confirming that trial risks and liabilities are covered, documents proving the device is manufactured according to relevant standards, the written consent of the heads of the participating institutions and of the clinical leads, and the affirmative opinions of the local independent ethics committees.
3. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009, Article 11¹¹: requirements for registration documents.
4. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012, Article 2(1)(f): conformity assessment carried out under international and European systems.
5. Practical estimate statement: applying the same chain to the registration dossier (outside clinical trials) is a practical extrapolation; no dedicated written provision exists.

3. Expert insights

Insight one: Government Decree No. 386 of 3 October 2023 is currently the only written evidence of the four-step chain.

The document requirements of the Georgian registration process are scattered across the principled provisions of Article 11¹¹ of Law No. 1586 of 10 August 2009, without an item-by-item enumeration of legalisation methods. The decree, by contrast, states the requirements for clinical trial documents explicitly. Using the written requirements as the yardstick for preparing registration documents is the most reliable strategy for making the form of the dossier beyond criticism, because it aligns the file with the only express standard the legislator has published.

The same yardstick also works defensively. When a reviewer questions the form of a registration document, pointing to the written requirements of the decree as the applied standard turns an open question into a closed one, because the applicant can show that the file meets a level Georgia itself has put in writing.

Insight two: the choice between apostille and consular certification is decided by the issuing country.

Whether a document takes the apostille route or the consular certification route depends on whether the country of issuance is a member of the Hague Apostille Convention. This is not a decision companies can make freely. If the convention status of the issuing country is not confirmed before scheduling, the wrong certification path may be chosen, and the resulting defect can render the whole document set unusable, requiring reissuance from the start. The confirmation step costs minutes; the error costs weeks.

A practical mapping rule follows: documents issued in Hague member states take the apostille, and documents from non-member states must pass through consular certification. Multi-country document sets, common when components and finished devices come from different suppliers, may need both routes within one dossier, so the scheduling table should be built per document, not per project.

Insight three: translation and notarisation are the last link of the chain and the one where work piles up.

Apostilles and consular certifications can be processed in parallel in the issuing country, but the Georgian translation must be completed locally. The duration of this step cannot be compressed, and it depends on the availability of qualified local translators. It should therefore be planned as an independent critical path item, started as early as possible, and never left until the rest of the dossier is finished.

4. Practical recommendations

1. Plan the legalisation chain as an independent critical path, with a budget of 6 to 8 weeks as a practical estimate.
2. Confirm the Hague Apostille Convention status of the issuing country first, then decide between apostille and consular certification.
3. Prepare the power of attorney to the highest standard of the decree: original, plus apostille or consular certification, plus notarisation.
4. Commission Georgian translations from qualified local translators, and obtain the translators’ qualification documents at the same time for the record.

5. Verification checklist

• □ The legalisation chain has been scheduled as an independent critical path
• □ The Hague Convention status of the issuing country has been confirmed
• □ The power of attorney has completed apostille or certification and notarisation to the highest standard
• □ The Georgian translations have been completed by qualified translators
• □ Translator qualification documents and the translated files have been archived together

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Georgian market, from legalisation chain planning and apostille routing to notarised Georgian translation management. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.