Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/1571-1 |
| Registreeritud | 08.02.2024 |
| Sünkroonitud | 27.03.2024 |
| 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 | Fitbit LLC |
| Saabumis/saatmisviis | Fitbit LLC |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Alina Mihai <[email protected]>
Sent: Thu, 08 Feb 2024 10:35:55 +0000
To: [email protected]
Cc: Shruti Rajagopalan <[email protected]>
Subject: Medical Device Software - Notification
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
I'm writing on behalf of Regulatory Dep. of Fitbit LLC, regarding the registration of a Medical Device Software (MDSW), class IIa under Regulation (EU) 2017/745. The medical device is now bearing the CE mark issued by TUV SUD.
According to the Estonian Medical Devices Act, a notification should be submitted to the Health Board when a medical device is distributed in Estonia for the first time. The notification process requires an importer or distributor established in Estonia.
In this scenario, the software is downloaded directly from the manufacturer's website and the Play Store. Consequently, the transaction is free of charge and does not necessitate the involvement of an importer or distributor in the supply chain.
Given that the medical device is distributed directly by a US manufacturer, could you kindly provide guidance on the requirements pertaining to registrations?
Thank you for your time and support!
Kind regards,
Alina Mihai
| Alina A. Mihai | | Sr. Regulatory Affairs Specialist | | DSPA/Fitbit | | +40-754-451-469 |
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 08.02.2024 | 48 | 11.1-2/24/1571-5 🔒 | Sissetulev dokument | ta | Fitbit LLC |
| Vastuskiri | 08.02.2024 | 48 | 11.1-2/24/1571-4 🔒 | Väljaminev dokument | ta | Fitbit LLC |
| Vastuskiri | 08.02.2024 | 48 | 11.1-2/24/1571-2 | Väljaminev dokument | ta | Fitbit LLC |
| Vastuskiri | 08.02.2024 | 48 | 11.1-2/24/1571-3 🔒 | Sissetulev dokument | ta | Fitbit LLC |