Georgia Medical Device Competent Authority 2026: LEPL Regulation Agency and Ministerial Powers

1. Key takeaways

The registration authority for medical devices in Georgia is the LEPL Regulation Agency for Medical and Pharmaceutical Activities, formerly the State Regulation Agency for Medical Activities (RAMA), operating under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs. Its statutory powers are granted by Article 3(3) of the Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, and its core functions are the granting of marketing authorisations and the maintenance of the departmental registry. The agency has no independent legislative competence for medical devices. This division of labour matters in day-to-day operations: the ministry sets the rules, the agency administers them, and any submission strategy that treats the two bodies as interchangeable will generate avoidable delays. Understanding exactly which function sits where, and on which legal provision each function rests, is a prerequisite for building an efficient communication plan with the Georgian authorities and for responding correctly to deficiency letters, inspection findings and post-authorisation requests.

The institutional lineage of the authority also deserves attention. Documents, certificates and inspection reports issued years ago may carry the former RAMA designation, while current correspondence uses the LEPL name, and both refer to the same legal person operating under the same ministerial umbrella. For dossiers, this means that historical evidence does not lose its probative value merely because of the rebranding, but companies should annotate the continuity explicitly when submitting older documents, so that reviewers do not need to reconstruct the institutional history themselves. A one-page mapping of the old designation to the new one, attached to the master file, resolves the question permanently and prevents the same clarification request from recurring across multiple submissions and multiple reviewing officers.

2. Legal basis

1. Law of Georgia on Medicines and Pharmaceutical Activities, Law No. 1586, adopted on 10 August 2009: Article 3(2)(b) on the role of the state in registration under the recognition regime, Article 3(2)(c) on approving the format and maintenance procedures of the departmental registry, Article 3(3)(a) on the agency granting marketing authorisations in Georgia, and Article 3(3)(c) on the agency maintaining the departmental registry.
2. Law of Georgia on Health Care, Law No. 6000, adopted on 21 March 2008: Article 67(1) provides that the ministry, together with the relevant state bodies, develops and implements quality and safety standards for medical technical devices and medical technology.
3. Government of Georgia Decree No. 278 of 1 August 2023 on the procedures, rules and conditions of control in the field of medical and pharmaceutical activities.

3. Expert insights

Insight 1: competence is split into two segments, with the ministry setting rules and the agency processing applications. Article 67(1) keeps the power to develop standards at the ministry level, while Article 3(3) assigns the power to issue certificates and maintain the registry to the agency. When a company faces a dispute about standards, escalating the matter to the agency will not help; the issue must be resolved at the ministry level. Conversely, in the intake, deficiency and certification stages the ministry does not deal with applicants directly. Practical experience shows that companies which route questions incorrectly receive either silence or a referral letter, both of which cost weeks. A disciplined mapping of each question type to the correct body, decided before the first letter is ever sent, is therefore not administrative nicety but a genuine schedule-protection measure for the whole project timeline. A useful test when classifying a question is to ask whether the answer would change the content of a standard or only the handling of a file. Questions about what a standard requires, how it is measured or when it applies belong to the ministry; questions about whether a document has been received, when a review concludes or how a deficiency should be corrected belong to the agency. Companies that apply this test in writing, and record the answer in the log, build over time a precedent library that shortens every subsequent exchange with the Georgian authorities.

Insight 2: the powers of the agency are conferred, not inherent. Article 3(3) enumerates the responsibilities of the agency item by item, which means that the agency has no authority to create requirements beyond the enumerated list. When a company receives a deficiency request that exceeds the enumerated scope, it can ask the authority to identify the specific legal provision on which the request is based. This is a pragmatic and frequently overlooked right in Georgian submissions. Invoking it politely, and in writing, creates a traceable record and filters out requests that lack a legal foundation, without damaging the working relationship with the reviewing officers.

Insight 3: Decree No. 278 of 2023 significantly expanded the on-site powers of the agency. The decree authorises the agency to carry out unannounced inspections at any time of day or night and to impose fines and suspend activities. Registration is only the entrance gate; the control exercised after entry has visibly strengthened over the last two years. Authorisation holders should therefore plan for inspection readiness as a permanent state, not as a one-off project tied to the initial registration, and should brief local distributors and warehouse operators accordingly, because inspectors will typically arrive at sites operated by local partners.

4. Practical recommendations

1. Maintain a dual-track communication log: standards questions go to the ministry, procedural questions go to the agency, and both types are never mixed in the same letter.
2. When a deficiency notice is received, request item-by-item citations of the legal basis for each request, building a traceable record of correspondence.
3. Prepare an inspection readiness package in advance, covering licences, batch records and the complaint log, in order to respond to unannounced inspections under Decree No. 278.
4. Monitor announcements on changes to the name and functions of the agency: the RAMA designation on historical documents and the current LEPL designation belong to the same institutional lineage.

5. Verification checklist

• □ Confirmed the current statutory name and ministerial affiliation of the counterpart authority
• □ Obtained the authentic text of Article 3 of Law No. 1586 and annotated the four enumerated responsibilities
• □ Established the dual-track communication log covering ministry and agency
• □ Prepared the inspection readiness package
• □ Checked the latest announcements on the official website of the agency

GRZAN international services — GRZAN assists manufacturers with authority engagement in Georgia, including communication routing between the ministry and the LEPL Regulation Agency for Medical and Pharmaceutical Activities, deficiency responses and inspection readiness. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026