Sissetulev dokumentAvalik
Kiri
Terviseamet · 26. juuli 2024
Seotud ettevõtted
- Viit
- 11.2-1/24/7703-1
- Registreeritud
- 26. juuli 2024
- Dokumendi liik
- Sissetulev dokument
- Adressaat
- IQVIA RDS Estonia OÜ
- Saabumis/saatmisviis
- e-post
- Funktsioon
- 11.2 SULETUD 2025 Turustamise eelne järelevalve (pre-marketing surveillance)
- Sari
- 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus)
- Toimik
- 11.2-1/2024
- Vastutaja
- Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Sisu (failidest)
Saatja: Laanesaar, Aina <[email protected]>
Saaja: Meditsiiniseadmed (Medical Devices)
Teema: Küsimus kliiniliste uuringute dokumentatsiooni kohta
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Tere!
Palun abi, et leida dokumentide nimekiri, mida on vaja meditsiiniseadme kliiniliseks uuringuks.
Tulemas on ravimiuuring, mis on kombineeritud diagnostilise seadme uuringuga.
Esitada tuleb paralleelselt Ravimiametisse ja Terviseametisse.
Protokolli mul hetkel veel ei ole.
Lugupidamisega,
Aina Läänesaar
Sr Site Activation Specialist
[cid:[email protected]]
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