| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/2444-1 |
| Registreeritud | 04.03.2024 |
| Sünkroonitud | 26.03.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | BD group |
| Saabumis/saatmisviis | BD group |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Barbara Björkbom <[email protected]>
Sent: Fri, 08 Sep 2023 06:27:56 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: Notification process Estonia
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
I am contacting you because I have a question in regards of the notification process in Estonia.
When the necessary documentation to add an already CE mark product to the Estonian database has been submitted, it is necessary to wait for confirmation that the product has been added in order to commercialize it in Estonia? Is it a notification with/without approval?
Sometime the confirmation of adding the CE mark product to the database can be delayed due to the need to clarify some aspects or provide additional documentation requested and the completion of the process can be postponed in a certain time.
Also, I would like to know if the notifications can only be made by local companies and distributors or is it possible for companies that do not have fiscal address in Estonia because to perform notification?
I thank you in advance for your kind support!
Best regards,
/Barbara Björkbom
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