Kiri

Dokumendiregister	Terviseamet
Viit	11.1-2/24/11559-1
Registreeritud	13.11.2024
Sünkroonitud	14.11.2024
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	B. Braun Medical OÜ
Saabumis/saatmisviis	B. Braun Medical OÜ
Vastutaja	Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal	Ava uues aknas

Failid

B_Braun tootja küsimus_ Registered_Notified Medical Devices - Changes’ impact.msg

From: Toomas Puskarjov <[email protected]>
Sent: Fri, 09 Jun 2023 08:06:36 +0000
To: MSA <[email protected]>
Subject: B.Braun tootja kÃ¼simus: Registered/Notified Medical Devices - Changesâ€™ impact

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

Tere

Edastan tootja B.Braun Melsungen küsimuse:

I am contacting you regarding the topic of global changes impacting the approved registration certificate/registered documentation / notification for medical devices (active, non-active), as I would require your support in better understanding which types of global changes would have an effect in your country.

The reason for this query is to become more efficient in the future, when evaluating the global impact of the changes, and to get in contact and inform you only when this would be applicable for you.

Please, answer on the following:

Do you have to inform the Authority about any changes? Yes/No
In case, the answer to the question 1 is ‘Yes’, which changes do you have to submit to the Authority?
Is there a law/guideline regulating the changes which have to be submitted to the Authority? Yes/No

if ‘Yes’, please, send the full version of the regulation in your language and just translate necessary part regarding changes’ impact into English.

Seni tuli teavitada seadmel tehtavatest olulistest muudatustest (kuigi ka need ei olnud väga täpselt määratletud).

Ette tänades,

Toomas Puskarjov

Regulatory Affairs Manager

Compliance Officer

+372 5139366

[email protected]

B. Braun Medical OÜ

Pilvetee 8

12618 Tallinn

Estonia

The information contained in this communication is confidential, may be attorney-client privileged, may constitute inside information, and is intended only for the use of the addressee. It is the property of the company of the sender of this e-mail. Unauthorized use, disclosure, or copying of this communication or any part thereof is strictly prohibited and may be unlawful. If you have received this communication in error, please notify us immediately by return e-mail and destroy this communication and all copies thereof, including all attachments.

Seosed

Nimi	K.p.	Δ	Viit	Tüüp	Org	Osapooled
Kiri	13.11.2024	1	11.1-2/24/11559-2	Väljaminev dokument	ta	B. Braun Medical OÜ