Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/7921-1 |
| Registreeritud | 05.08.2024 |
| Sünkroonitud | 06.08.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
| Toimik | 11.1-2/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Abbott |
| Saabumis/saatmisviis | Abbott |
| Vastutaja | Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: RegulatoryEUEFTA <[email protected]>
Sent: Thu, 01 Aug 2024 12:56:54 +0000
To: "[email protected]" <[email protected]>
Subject: IVDR notification_missing ET IFU translation
Dear All,
Could you please be so kind and clarify Language requirements for notification in vitro medical devices in Estonia?
Our products are intended for use by professionals. According to ET law it is allowed to put on the market such products with English IFU.
Could you please confirm how notify such products as one of the required documents which should be uploaded to data base is IFU in Estonian language? In case of products for professional users can we submit the notification without ET IFU? Should we submit as an attachment statement/justification why ET translation is missing?
Thank you,
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Best regards, Emilia Adamczyk |
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 05.08.2024 | 1 | 11.1-2/24/7921-2 | Väljaminev dokument | ta | Abbott |