Regulation Agency for Medical and Pharmaceutical Activities (RAMA) GovernmentGovernment Decree No. 334 of 7 October 2024
Government Decree No. 334 of 7 October 2024 is the official RAMA identifier for “Amendment to Decree No. 386 — Clinical Investigation of Registered-Device Analogues”. Government Decree No. 334 of 7 October 2024 is the official identifier RAMA uses for this instrument.
- Instrument
- Government
- Full name
- Government Decree No. 334 of 7 October 2024
- Category
- Clinical Trials
- Authority source
- Georgian
- Readable HTML
- 2 articles · 1 language version
- Published
- 8 October 2024
- Effective
- 8 October 2024
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Amendment to Decree No. 386 — Clinical Investigation of Registered-Device Analogues
საქართველოს მთავრობის 2024 წლის 7 ოქტომბრის №334 დადგენილება, in force on publication. Adds paragraphs 3–5 to Art. 7 of the Technical Regulation approved by Decree No. 386 (Annex No. 1): the requirement of para. 2 does not apply to a clinical investigation carried out in a country recognised by Government Decree No. 188 of 22 October 2009 where the device is an analogue/substitute of the same manufacturer's already registered device with improved technical characteristics, the previous generation is on the market of a recognised country, and the country of manufacture is on that same list. Para. 4 adds the documents the applicant must file (opinion of an authoritative professional association, recommendation of the Georgian National Bioethics Council, informed-consent form) and para. 5 assigns the decision to the Minister or a specialist group. Two articles only.
Government Decree No. 334 of 7 October 2024 is the official identifier RAMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.