Küsimused

Dokumendiregister	Ravimiamet
Viit	MSO-2/2176-4
Registreeritud	29.04.2025
Sünkroonitud	30.04.2025
Liik	Väljaminev kiri
Funktsioon	MSO Meditsiiniseadmed
Sari	MSO-2 Eesti turule lastavate/kasutusele võetavate/levitatavate seadmete teavitused ning EC sertifikaadid
Toimik	MSO-2/2025
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	UAB „BIOMEDIKA“
Saabumis/saatmisviis	UAB „BIOMEDIKA“
Vastutaja	Karl Kalev Türk (RA, Meditsiiniseadmete osakond)
Originaal	Ava uues aknas

Failid

Vs_ Medical devices registration.msg

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Vs_ Medical devices registration.msg

From: RA MSO <[email protected]>
Sent: Mon, 28 Apr 2025 07:25:28 +0000
To: Kristupas Žegunis <[email protected]>
Subject: Vs: Medical devices registration

Dear Kristupas,

Thank you for your letter.

Indeed, adding a new organisation into the database needs to be validated by the processor. This is usually done within the working day. After that, you are able to link yourself with the newly added organisation.

If you require any further assistance, please let me know.

Best regards,

Karl Kalev Türk
Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

Saatja: Kristupas Žegunis <[email protected]>
Saatmisaeg: esmaspäev, 28. aprill 2025 10:22
Adressaat: RA MSO <[email protected]>
Teema: Re: Medical devices registration

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

Good morning,

Have entered company Biomedika data, so should wait for the confirmation, correct?

______________

Kristupas Žegunis

BALTIJOS REGIONO VERSLO VYSTYMO VADOVAS / BUSINESS DEVELOPMENT MANAGER IN BALTICS REGION

Mob. +37065800345

Informacija šiame pranešime gali būti konfidenciali. Ji skirta tik asmeniui, kuriam yra adresuota. Jei Jūs nesate tas asmuo (arba atsakingas už šio pranešimo pristatymą tam asmeniui), prašome neskaityti, nekopijuoti ir neplatinti šio pranešimo ar jame esančios informacijos. Jei šį pranešimą gavote per klaidą, prašome informuoti apie tai siuntėją ir ištrinti visas šio pranešimo kopijas iš savo kompiuterio. Dėkojame.

From: RA MSO <[email protected]>
Date: Wednesday, 16 April 2025 at 14:48
To: Kristupas Žegunis <[email protected]>
Subject: Vs: Medical devices registration

---- Išorinis el. laiškas: Nespauskite nuorodų ar priedų, nebent atpažįstate siuntėją ----

---- External email: Do not click on links or attachments unless you recognize the sender ----

Dear Kristupas,

Thank you for your enquiry.

According to our database, you do have an account, however you are not currently linked to any company. To notify us about distribution in order to comply with the national distribution notification requirement in Estonia (Medical Device Act §26(4)), you must first add your company to the database and then link yourself to it.

To add a new company, please log in to the database and select „New application“ → „Add new organisation“.

Once this has been confirmed by us, you can then link yourself to the company by choosing „New application“ → „Bind yourself to organisation”.

After this is done, you will see the option to called „Notify about medical device distribution in Estonia“ under „New application”.

More detailed practical information can be found in the short guide for using the Estonian Medical Device Database available under „Forms” on the database homepage.

Feel free to contact me if you need any further information.