Georgia Medical Device Registration Dossier Checklist: Two-Volume Format and Document Requirements

1. Key takeaways

The Georgian registration dossier should be bound as two volumes, an administrative volume and a technical volume. The legal anchor is Law No. 1586 of 10 August 2009 on Drugs and Pharmaceutical Activity, Article 11¹¹. That provision treats administrative review and scientific-technical review as two independent stages of the registration procedure, and it regulates the requirements for registration documents and the registration fee side by side within the same article. Binding the dossier in two volumes mirrors those two review stages, and this structural choice is one of the most effective ways to reduce the overall risk of rejection at intake.

The administrative volume answers one question: who is applying, on whose authority, and whether the fee has been paid. It should open with the fee payment receipt rather than the application form, because Article 11¹¹ places the registration fee next to the document requirements. A complete application without proof of payment is one of the most common, and most avoidable, causes of a first-round rejection, so the financial action is deliberately moved to the front of the file.

The technical volume answers a different question: what the product is, who it is used on, what risks it carries, whether those risks are controlled, and whether the evidence supports the claims. Sequencing the technical volume along this chain of reasoning reproduces the way a scientific reviewer thinks, which lowers the reviewer’s search cost and measurably shortens the number of deficiency rounds.

Two cautions apply. The two-volume binding method, the page numbering rules and the number of copies are not prescribed in any published legal provision; they are a practical estimate drawn from submission experience. In addition, every foreign document entering the dossier must pass through the four-step legalisation chain reflected in Government Decree No. 386 of 3 October 2023: original issuance, apostille or consular certification, notarisation, and a notarised Georgian translation.

A workable division of content follows the two reviews. The administrative volume holds the application form, the identity proof of the interested party as defined in Article 1¹, the power of attorney, and the fee receipt, together with the confirmation of entry in the departmental register under Article 11⁶ where applicable. The technical volume holds everything a scientific reviewer needs: the product description, the intended use, the risk analysis, the performance and clinical evidence, and the conclusions. Each volume carries its own table of contents and its own page numbering, so that a reference made inside one volume never depends on the other volume being at hand.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009: Article 11¹¹ (application, administrative review, scientific-technical review, requirements for registration documents, registration fee).
2. Article 1¹, definition of an interested party: an entity willing to register a product under the recognition procedure or under the national procedure.
3. Article 11⁶: entry of the medicinal product in the departmental register.
4. Article 12(2): the legality of manufacturing an unregistered product for registration purposes, which supports the submission of samples alongside the dossier.
5. Government Decree No. 386 of 3 October 2023 of Georgia, Article 4: documents must be accompanied by notarised Georgian translations, and the sponsor’s power of attorney must be apostilled or consularly certified and then notarised.
6. Practical estimate statement: the two-volume binding method, the page numbering rules and the number of bound copies are not found in any official legal text; they derive from submission experience.

3. Expert insights

Insight one: Article 11¹¹ places the registration fee next to the document requirements, which makes the payment receipt a formal element of the file.

The first page of the administrative volume should therefore be the fee receipt, not the application form. Moving the financial action to the front allows the administrative review to pass in the first round and avoids the low-level rejection of a dossier that is materially complete but lacks the payment voucher. Reviewers process administrative files quickly; any missing formal element restarts the cycle, and a missing fee receipt is the easiest deficiency to detect and the easiest one to prevent at assembly time.

Insight two: the technical volume should replicate the chain of reasoning of the scientific review.

The scientific-technical review under Article 11¹¹ is a professional judgment process. A dossier organised in the order of what the product is, who uses it, what the risks are, whether the risks are controlled, and whether the evidence supports the claims, allows the reviewer to move through the file in a single forward pass. Every backward search a reviewer must perform is a potential question, and every question is a potential deficiency letter. The ordering of chapters is therefore not cosmetic; it is a direct instrument for controlling review time.

Insight three: the document requirements of Government Decree No. 386 of 3 October 2023 can be read backwards as a general formality standard.

The decree requires that clinical trial protocols and informed consent documents carry notarised Georgian translations, and that powers of attorney be submitted as originals or with apostille or consular certification and notarisation. This is an explicit written example of Georgia’s legalisation requirements for foreign documents. Preparing the registration dossier to the same standard is a defensible way to reach an acceptable level of formality even though the registration chapter itself states the requirement only in principle.

4. Practical recommendations

1. Self-check the administrative volume against 4 items: the application form, proof of identity of the interested party, the power of attorney, and the fee payment receipt.
2. Organise the technical volume in 5 sections: product description; intended use and target population; risk analysis; performance and clinical evidence; and conclusions.
3. Number and index the two volumes independently, so that cross-references between them do not create retrieval difficulties for the reviewer.
4. Process every foreign document through the four-step chain of original, apostille or consular certification, notarisation, and Georgian translation, keeping the file aligned with the standard set by Government Decree No. 386 of 3 October 2023.

5. Verification checklist

• □ The 4 formal elements of the administrative volume are complete and have passed self-check
• □ The technical volume is organised in 5 sections and independently numbered
• □ Separate tables of contents have been prepared for both volumes
• □ Foreign documents have completed the four-step legalisation chain
• □ Sample submission has been justified under Article 12(2) of Law No. 1586

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 two-volume dossier assembly and administrative self-checks to legalisation chains and reviewer-ready technical files. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.