Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/5940-3 |
| Registreeritud | 06.06.2024 |
| Sünkroonitud | 07.06.2024 |
| 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 | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Freyr |
| Saabumis/saatmisviis | Freyr |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Hariharan <[email protected]>
Sent: Mon, 09 Jan 2023 06:13:18 +0000
To: "[email protected]" <[email protected]>
Cc: Praveen Kumar J <[email protected]>
Subject: RE: Notification of CE-Marked device - Estonia
Hello Sir/Madam,
This is a gentle follow-up to the below query.
Thanking you in advance.
_ _
Hariharan
Assistant Manager – MDV
|
|
| Email ID: hariharan@freyrsolutions.com | www.freyrsolutions.com |
From: Hariharan
Sent: Wednesday, December 7, 2022 7:07 PM
To: [email protected]
Cc: Praveen Kumar J <[email protected]>
Subject: Notification of CE-Marked device - Estonia
Hello,
I’m Hariharan from a regulatory consulting company and a regulatory partner for a manufacturer. I have a query on the notification of the CE-marked product.
One of our clients is a manufacturer based in Poland that developed software (CE-marked under MDR, Class I) and they want to market the product in Estonia. Kindly guide us with the following queries to market the product in Estonia.
- Do we need to do additional notification/registration to sell the CE-marked products in Estonia?
- Should the manufacturer have a local distributor/importer for software to market the product?
- Does the regulation have any local language preference for Software interface?
Kindly help us in understanding the requirement for marketing the device in Estonia.
Thanking you in advance.
_ _
Hariharan
Assistant Manager – MDV
|
|
| Email ID: hariharan@freyrsolutions.com | www.freyrsolutions.com |
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5940-4 | Väljaminev dokument | ta | Freyr |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5940-2 | Väljaminev dokument | ta | Freyr |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5940-1 | Sissetulev dokument | ta | Freyr |