Georgia Medical Device Power of Attorney: Formal Requirements and Authorised Representative Rules

1. Key takeaways

The power of attorney is a high-frequency rejection point in Georgian submissions, and its formal requirements have a clear written basis. Government Decree No. 386 of 3 October 2023 requires the power of attorney issued by the sponsor to be submitted as an original, apostilled or consularly certified, and notarised. Although the manufacturer declaration is not subject to an equally explicit written requirement, it should be prepared to the same standard.

The legal logic behind the document is captured by Article 4(1)(b) of the Product Safety and Free Movement Code, Law No. 6157-Iს of 8 May 2012. That provision addresses the representative of a foreign manufacturer in Georgia, and the person placing the product on the market in Georgia, and provides that where the foreign manufacturer has no representative in Georgia, the manufacturer itself bears the role. In other words, when no local representative exists, liability falls directly on whoever places the product on the market. The substantive function of the power of attorney is to make explicit who bears responsibility in Georgia; the formal requirements are the external guarantee of that function.

Two further rules govern quality. The scope of authorisation must cover the specific acts to be performed, item by item. And the chronological order of the power of attorney and the manufacturer declaration cannot be inverted, because the declaration supplies the underlying facts on which the authorisation rests.

In practice the rejection points concentrate on three things: a missing formal element such as an apostille or a notarisation; an authorisation scope too generic to cover the specific acts of the submission; and dates that contradict other documents in the dossier. All three are detectable in a ten-minute internal review before filing, which is why the checklist in this article matters more for the power of attorney than for most other documents. The five-item minimum of authorised acts described below is a floor, not a ceiling; where the submission strategy includes classification confirmation letters or change filings, those acts should be added explicitly.

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.
2. The same article: the written consent of the heads of the participating medical institutions and of the clinical leads, and the well-substantiated 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 1¹, the definition of an interested party: an entity willing to register a product under the recognition procedure or under the national procedure.
4. Article 11¹¹: requirements for registration documents, registration fee, application.
5. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012, Article 4(1)(b): the representative of a foreign manufacturer in Georgia, and the person placing products on the market in Georgia, or where the foreign manufacturer has no representative in Georgia, the manufacturer.

3. Expert insights

Insight one: Article 4(1)(b) treats the person placing products on the market as the manufacturer when no local representative exists.

This is the most important legal principle behind the power of attorney. Georgian law, in the absence of a local representative, places responsibility directly on the person who puts the product on the market. The substantive function of the power of attorney is therefore to make explicit who bears responsibility in Georgia. The formal elements, original, apostille or consular certification, notarisation, are the external guarantees that this allocation of responsibility is authentic and attributable.

The manufacturer declaration should also name the manufacturer exactly as named on the certificate and the labelling, because mismatches between entity names across the dossier generate clarifications even when every formality is otherwise correct. Entity naming consistency is a zero-cost control: it requires only a cross-check against the registration documents at drafting time.

Insight two: the scope of authorisation must cover the specific acts.

The various written consents and document submissions enumerated in Government Decree No. 386 of 3 October 2023 each require a corresponding authorisation. A generic power of attorney stating only general and unlimited authority tends to show authorisation defects at the level of specific acts. The authorisation should list, item by item: filing the application, signing documents, receiving notifications, paying fees, and handling changes and renewals.

Where the same authorised representative handles multiple products, a per-product power of attorney is safer than a global one, because a global document must then correctly enumerate every product, every act and every market entry route in a single text, and any gap in that enumeration becomes a defect across the whole portfolio.

Insight three: the chronological order of the power of attorney and the manufacturer declaration cannot be inverted.

The manufacturer declaration is the source of the underlying facts, who the manufacturer is and what is manufactured, and the power of attorney is the act of authorisation. If the power of attorney is dated before the manufacturer declaration, a logical defect arises: authorisation was granted before the authorising entity was confirmed. This is a formal problem that reviewers can readily identify, and it is entirely avoidable at drafting time.

Set the validity period generously and align the renewal calendar of the power of attorney with the renewal calendar of the registration itself, so that a renewal filing is never blocked by an expired authorisation. An authorisation that lapses mid-cycle can hold up a change filing or a renewal for weeks while a replacement document passes through legalisation again.

4. Practical recommendations

1. Itemise the authorised acts in the power of attorney, covering at least 5 items: filing the application, signing documents, receiving notifications, paying fees, and handling changes and renewals.
2. Complete the original, plus apostille or consular certification, plus notarisation, in line with Government Decree No. 386 of 3 October 2023, and attach a Georgian translation.
3. Check the date order of the power of attorney against the manufacturer declaration, with the declaration first and the authorisation second.
4. Keep the validity period of the power of attorney covering the entire registration cycle, with a reserve window for renewals and changes.

5. Verification checklist

• □ The power of attorney itemises no fewer than 5 authorised acts
• □ The original, plus apostille or consular certification, plus notarisation, has been completed
• □ A Georgian translation has been attached
• □ The date order of the power of attorney and the manufacturer declaration is correct
• □ The validity period of the power of attorney covers the registration and renewal cycle

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 power of attorney drafting, itemised authorisations and legalisation to responsibility mapping under the Product Safety and Free Movement Code. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.