Regulation Agency for Medical and Pharmaceutical Activities (RAMA) GovernmentGovernment Decree No. 386 of 3 October 2023
Government Decree No. 386 of 3 October 2023 is the official RAMA identifier for “Technical Regulation on Clinical Investigation of Medical Devices”. Government Decree No. 386 of 3 October 2023 is the official identifier RAMA uses for this instrument.
- Instrument
- Government
- Full name
- Government Decree No. 386 of 3 October 2023
- Category
- Clinical Trials
- Authority source
- Georgian
- Readable HTML
- 19 articles · 1 language version
- Published
- 4 October 2023
- Effective
- 4 October 2023
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Technical Regulation on Clinical Investigation of Medical Devices
საქართველოს მთავრობის 2023 წლის 3 ოქტომბრის №386 დადგენილება. Approves the Technical Regulation on the clinical investigation of medical devices (Annex No. 1) and, as Annex No. 1.1, the rules for classifying medical devices, including the definitions of transient, short-term and long-term use. Art. 2 defines the Ministry and the Agency, the latter as the public-law legal entity under the Ministry's state control — სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო. Ingested in Georgian from matsne.gov.ge document 5934377, the version published 04/10/2023; the amended consolidated view is behind matsne's paid consolidated-version service, so the 2024 amendment is carried as its own expression.
Government Decree No. 386 of 3 October 2023 is the official identifier RAMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.