Selgitustaotlus

Dokumendiregister	Terviseamet
Viit	11.1-2/24/1060-2
Registreeritud	30.01.2024
Sünkroonitud	27.03.2024
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	Thema RA
Saabumis/saatmisviis	Thema RA
Vastutaja	Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal	Ava uues aknas

Failid

Vs_ REGISTRATION MD_DISTRIBUTOR INFORMATION.msg

image001.png

Vs_ REGISTRATION MD_DISTRIBUTOR INFORMATION.msg

From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Tue, 30 Jan 2024 06:38:10 +0000
To: Federica Sannelli <[email protected]>
Subject: Vs: REGISTRATION MD/DISTRIBUTOR INFORMATION

Dear Federica,

Thank you for your enquiry.

The law does not foresee a specific deadline for updating documents in the MSA database, but distributors have the possibility to correct or update data and documents on an ongoing basis, if necessary.

Nevertheless, we recommend updating documents and data where possible, especially if the data on the device application form change, for example, the number of an authorised representative or notified body.

If a distribution of a device has been notified in the MSA and there are specific REF numbers/models in the MSA that are affected by the change (i.e. new numbers not reflected in the MSA), then an update is required. Otherwise, the device/model with the changed REF number has not been notified, i.e. the obligation to notify the distribution has not been fulfilled.

However, if there is a change in the manufacturer of the device, it will be treated as a new device and a new notification of distribution should be made.

In addition, with the transition from directives to regulations, there is a high likelihood that device specifications, models, intended use of the medical device or, for example, the Notified Body number will also change.

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

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: Federica Sannelli <[email protected]>
Saatmisaeg: neljapäev, 25. jaanuar 2024 16:28
Adressaat: TA Info <[email protected]>
Teema: REGISTRATION MD/DISTRIBUTOR INFORMATION

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

Hello,

I’m an Italian Regulatory Affair Specialist and I’m writing to you in order to have further information about the medical device and distributor registration into the Estonian register.

Here is the question: once the distributor has made the registration and has registered the medical device, do they have an expiration date and do they need to be renewed? If the answer is positive, after how much time is the registration invalid and need to be renewed?

Thanking you in advance.

Sincerely,

Federica Sannelli

Federica Sannelli
RA Specialist

RAPS MEMBER: https://bcert.me/sgmmoegjl

Tel: +39 0542 643496

Fax: +39 0542 641833

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Nimi	K.p.	Δ	Viit	Tüüp	Org	Osapooled
Selgitustaotlus	26.01.2024	61	11.1-2/24/1060-1	Sissetulev dokument	ta	Thema RA