| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/2445-1 |
| 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 08:43:21 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: National rule on reprocessing of single use devices in Estonia
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
I contact you because I would like to know if there is any national rule on reprocessing of single use devices in Estonia and if would be accepted the commercialization/shipment of remanufactured products? if so is there is any document required for notification of remanufactured products (specific labeling/specific post market surveillance for remanufactured products?
I am not aware if it is not authorized reprocessing of single-use devices (medical and in vitro diagnostic devices) on your territory, and if this coming in the local legislation.
Can you kindly advice?
Thank you
Best regards,
/Barbara Björkbom
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