Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/6340-1 |
| Registreeritud | 13.06.2024 |
| Sünkroonitud | 18.06.2024 |
| 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 | Baltrade |
| Saabumis/saatmisviis | Baltrade |
| Vastutaja | Egle Audova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Britta Nylund <[email protected]>
Sent: Mon, 10 Jun 2024 09:07:51 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Cc: Karl Kalev Türk <[email protected]>
Subject: Used medical device instruments
Importance: High
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Terviseamet,
We have received an inquiry from our supplier regarding the Estonian regulation regarding used medical devices / Instruments.
Please let me know if you can help me with the questions below.
- Are used instruments allowed on your market?
- What is the exact regulation covering the acceptance of „used“ instruments?
- What is the exact regulation covering the repacking and relabelling of medical devices?
- May used instruments be shipped into the country from another country?
- Are there any additional label requirements for used instruments on your market?
- Are there any additional requirements for used instruments on your market?
Looking forward hearing from you.
Thank you very much and best regards,
Operations & Quality Manager
+358 10 292 4632
Sipoonranta 10 B LT 1, FIN-01120 Västerskog
Finland
ISO 13485:2016 Certified
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6340-2 | Väljaminev dokument | ta | Baltrade |