Dokumendiregister | Terviseamet |
Viit | 11.1-2/24/5088-2 |
Registreeritud | 14.05.2024 |
Sünkroonitud | 15.05.2024 |
Liik | Väljaminev 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 | Quality First International |
Saabumis/saatmisviis | Quality First International |
Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Fri, 10 May 2024 12:25:42 +0000
To: Mariana Terentii <[email protected]>
Subject: Vs: UNREGISTRATION OF A MANUFACTURER WITH TERVISEAMET
Dear Mariana Terentii,
Thank you for your inquiry and your kind wishes. Wishing you a pleasant weekend as well.
Please select the application named „Report discontinuation of manufacturing“ in the device profile under „New procedure“ as these devices with the data entered (you as an AR in this case) in the database, are no longer manufactured.
Once done, the status of these devices will be marked as discontinued.
After that, you can also remove yourself as a distributor of these devices by clicking „End distribution“ in the device profile. This action will clear your list of devices in the „My procedures“ -> „My devices“ list.
Please do not hesitate to contact me for further information or any questions.
Best regards,
Karl Kalev Türk
Chief Specialist
Department of Medical Devices
Phone +372 5648 5663
[email protected] | [email protected]
Republic of Estonia Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn Estonia |
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Mariana Terentii <[email protected]>
Saatmisaeg: reede, 10. mai 2024 13:23
Adressaat: Karl Kalev Türk <[email protected]>
Teema: [POTENTIAL PHISHING]UNREGISTRATION OF A MANUFACTURER WITH TERVISEAMET
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Mr. Türk,
We would like to unregister BioHorizons Implant Systems, Inc company as we will not longer represent them as EU Authorised Representative. Could you kindly let us know the best way to unregister them, please?
There is a procedure on Terviseamet – “Remove Authorised representative data”, but unsure if this is applicable for us. When creating a new application for manufacturer registration we need to add QFI as Authorised Representative and add QFI as a Distributor.
I look forward for further instructions. Have a nice weekend.
Best regards,
Mariana Terentii
Market access and registration support administrator
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Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
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Kiri | 14.05.2024 | 1 | 11.1-2/24/5088-1 | Sissetulev dokument | ta | Quality First International |