LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) current fee schedule, reviewed for 2026, in GEL.
5 fee lines100% exact amountscurrency GELFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Medical-device clinical-investigation application review fee β Class I Column 26 of the Article 5 table of Decree No. 586 of 2 December 2019, inserted by Decree No. 384 of 3 October 2023. | GEL 10,000 | $3,840 | Per application | Verified |
| Medical-device clinical-investigation application review fee β Classes IIa, IIb and III Column 26.1 of the same table, inserted by Decree No. 384 of 3 October 2023; the tariff is flat across the three higher classes. | GEL 30,000 | $11,521 | Per application | Verified |
| Extension of the validity of a Class I medical-device clinical-investigation certificate Same column of the amended Article 5 table. | GEL 5,000 | $1,920 | Per extension | Verified |
| Extension of the validity of a Classes IIa, IIb and III medical-device clinical-investigation certificate Same column of the amended Article 5 table. | GEL 15,000 | $5,760 | Per extension | Verified |
| Amendment of a medical-device clinical-investigation certificate Same column of the amended Article 5 table. | GEL 1,000 | $384 | Per amendment | Verified |
Government fees only β service and testing costs are separate- These are the only fees this round could evidence for a medical device in Georgia, and they are charged for a clinical investigation, not for a market-placement registration: Georgia has no general medical-device pre-market registration, so a device that is not the subject of a clinical investigation attracts no RAMA device fee.
- The bands above map the tariff's own risk graduation: the Class I rate is the low-risk band and the single flat Classes IIa/IIb/III rate is the high-risk band.
- Refusal of a clinical-investigation application refunds 70 per cent of the fee paid, per the same column of the amended Article 5 table.
- No amount fixing a medical-device state-registration fee was located. The Law on Medicines requires evidence of payment of a registration fee (Articles 11^11(7) and 11^11(19)(α)) and Article 11^11(23) states that the amount of the state-registration fee for a pharmaceutical product under the national regime is fixed by law, but that article governs pharmaceutical products; the category of medical goods has no registration regime or fee attached.
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Exact amounts verified against the LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) fee schedule Β· full review 2026-09-16 Β· row IDs are stable β cite as government-fees:georgia:clinical-investigation-application-class-i