Georgia Medical Device Submission Format: Paper and Electronic Dossier Strategy

1. Key takeaways

Georgian medical device submissions should adopt a dual-form strategy of paper for legal proof and electronic for use. Documents that must exist as notarised or apostilled originals go in paper form; the technical and clinical parts go in electronic form. The legal basis is Article 11¹¹ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009, on the requirements for registration documents, together with the explicit requirements for originals and notarised copies in Government Decree No. 386 of 3 October 2023. The detailed rules for the split between forms are a practical estimate, not written law.

The split is not an arbitrary preference. Originals of powers of attorney, apostilled documents and notarial certificates carry their legal effect on the paper medium and the seals attached to it; scans do not have equivalent effect. Placing them in the paper channel and everything else in the electronic channel is the optimal point between legal validity and submission efficiency.

A supporting signal comes from the inspection side. Government Decree No. 278 of 1 August 2023 requires inspected parties to submit documents in both electronic and material forms. Although that rule applies at the inspection stage, it reflects how the authority works: electronic for retrieval, paper for evidence. Following the same logic at submission aligns the file with the habits of the receiving end.

A workable channel split in practice looks like this: the application, the fee receipt, the power of attorney with its legalisation set, the manufacturer declaration and any notarised translations travel on paper; the technical volume, the risk management report and the clinical evidence travel electronically, indexed to the same numbering system as the paper volumes. The numbering must be shared across both channels, because the two halves of the file are reviewed as one dossier. Submission receipts should be scanned and filed the day they are issued, since the receipt date anchors every downstream deadline for deficiency responses and renewals.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009: Article 11¹¹ (requirements for registration documents, administrative review, scientific-technical review).
2. Article 11⁶: entry in the departmental register; Article 11⁵: validity period of the marketing authorisation.
3. Government Decree No. 386 of 3 October 2023 of Georgia, Article 4: the power of attorney must be an original or apostilled or consularly certified and notarised; the protocol and informed consent documents must carry notarised Georgian translations.
4. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012, Article 2(1)(f).
5. Government Decree No. 278 of 1 August 2023 of Georgia: inspected parties must submit documents in both electronic and material forms.
6. Practical estimate statement: the boundary between electronic and paper forms, the combinations of language versions and the number of copies are not prescribed in any official legal text; they derive from submission experience.

3. Expert insights

Insight one: Government Decree No. 278 of 1 August 2023 implies the authority’s expectation of dual forms.

The decree requires inspected parties to submit documents in both electronic and material forms. Although written for the inspection stage, it reveals the working habits of the authority: electronic files for searching, paper for taking evidence. Reusing that logic at the submission stage maximises alignment with how the receiving side actually processes files, and it costs nothing beyond ordinary document management discipline.

The same habit also implies a document management standard: electronic copies should be faithful, named systematically and versioned, because a copy that cannot be matched to its paper original creates exactly the confusion the dual-form system is meant to avoid. The match between channels should be verifiable from the file names alone, without opening any document.

Insight two: original documents cannot be digitised; that is a physical constraint, not an administrative preference.

The legal effect of an original power of attorney, an apostille or a notarial certificate attaches to the paper medium and the signatures and seals on it. A scanned copy does not carry the same effect. Routing these documents through the paper channel while sending the technical and clinical content through the electronic channel is the optimal solution between legal validity and submission efficiency. Trying to force everything electronic weakens the formal elements; trying to force everything paper wastes the advantages of electronic files.

The boundary should be recorded in the language statement table as well, since the paper and electronic channels often carry different languages for the same dossier part, and the table is where the reviewer resolves that map before reading anything else.

Insight three: the combination of language versions should be designed from the reviewer’s point of view.

Submitting the technical and clinical parts in English serves professional review; submitting the administrative and labelling parts in Georgian serves formal review and local verification. Multiple languages coexisting in one dossier is acceptable, provided every choice of language has a clear reason and is stated in the table of contents. The language map is itself a review aid: it tells the reviewer where to look in which language, and it prevents the most common retrieval failures.

One more design rule follows from the same logic: never let a language change mid-section without a stated reason. A section that switches language silently looks like a missing translation, and missing translations are treated as missing documents, which restarts the deficiency cycle.

4. Practical recommendations

1. Split the channels by document nature: originals, notarised and apostilled documents go on paper; technical and clinical content goes electronic.
2. Build the electronic file as a directory tree following the two-volume structure described for the dossier, with volume and section numbers in the file names.
3. Attach a language statement table at the front of the dossier, listing the language version and the reason for each part.
4. Keep the complete submission receipts and document lists, as the original reference for later changes and renewals.

5. Verification checklist

• □ Paper and electronic channels have been split by document nature
• □ The electronic directory tree has been built following the two-volume structure
• □ The language statement table at the front of the dossier is complete
• □ Submission receipts and document lists have been retained
• □ It has been confirmed that the legal effect of original documents is not weakened by digitisation

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 paper and electronic channel design and language statement tables to submission receipts and renewal-ready archives. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.