Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/12870-1 |
| Registreeritud | 17.12.2024 |
| Sünkroonitud | 18.12.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 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 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | IQVIA MedTech |
| Saabumis/saatmisviis | IQVIA MedTech |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Podolak, Amira" <amira.podolak@iqvia.com>
Sent: Mon, 02 Dec 2024 09:07:12 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Cc: "Farinha; Ana" <ana.farinha@iqvia.com>
Subject: Change of competent authority for medical devices studies
Dear Sirs,
I would like to ask if there is any break planned for the Christmas period. If we apply before Christmas, is it likely that we will receive validation comments by the end of this year?
In addition, I would like to make sure how the evaluation of applications will look like due to the change in the authority for medical device testing? Will applications submitted in December still be evaluated by the Health Board, or will they be transferred to the State Agency of Medicines with the new year?
I would also like to ask if we do not manage to submit the application in December and have to submit it to the State Agency of Medicines in January, does the fee we have already submitted remain valid? Would we have to start some kind of procedure to redirect the funds or refund and make the payment again to the new competent authority?
I would highly appreciate your feedback on these matters.
Kind regards,
Amira Podolak, Ph.D.
Associate Regulatory & Start-Up Manager
IQVIA MedTech, Clinical Operations
Learn more about IQVIA MedTech
Home Based (Gdynia, Poland)
tel. +48 22 430 31 34
Upcoming ooo: 23-24Dec (holidays), 25-26Dec (BH), 27-31Dec (holidays), 01Jan (BH)
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 17.12.2024 | 1 | 11.2-1/24/12870-3 | Sissetulev dokument | ta | IQVIA MedTech |
| Vastuskiri | 17.12.2024 | 1 | 11.2-1/24/12870-4 | Väljaminev dokument | ta | IQVIA MedTech |
| Vastuskiri | 17.12.2024 | 1 | 11.2-1/24/12870-2 | Väljaminev dokument | ta | IQVIA MedTech |