Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/13070-1 |
| Registreeritud | 23.12.2024 |
| Sünkroonitud | 24.12.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Meditsiinigrupp AS |
| Saabumis/saatmisviis | Meditsiinigrupp AS |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Annika Niitsoo <[email protected]>
Sent: Thu, 19 Dec 2024 11:42:50 +0000
To: MSA <[email protected]>
Subject: FW: Question_Economic operators registration requirements
Importance: High
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Tere
Saadan edasi tootja küsimused, millest enamustele ei ole vastused hästi leitavad.
Kas teil oleks võimalik aidata?
Lugupidamisega
|
Annika Niitsoo Büroojuht Meditsiinigrupp AS |
|
From: Galanova, Svitlana <[email protected]>
Sent: Friday, December 13, 2024 2:55 PM
To: Annika Niitsoo <[email protected]>
Subject: Question_Economic operators registration requirements
Importance: High
Hello Annika,
Hope you are doing great.
I need your kind support and clarification on economic operators registration requirements in Estonia.
Would you be so kind to answer following questions:
- Registration/Notification of Distributor based in the country required?
- Registration/Notification of Distributor placed outside country required?
- Validity time for distributor Registration/Notification? (in years)
- Importer Registration/Notification to local CA required?
- Validity time for importer Registration/Notification?
- Changes in requirements expected with EUDAMED introduction?
I would be grateful to get your response by Wednesday, 18th of December.
Thank you.
Best regards,
Svitlana Galanova
RA Manager
Philips CEE
Slovenia, 1000 Ljubljana
Dolenjska cesta 242b,
Email: [email protected]
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 23.12.2024 | 1 | 11.1-12/24/13070-2 | Väljaminev dokument | ta | Meditsiinigrupp AS |