Dokumendiregister | Ravimiamet |
Viit | MSO-2/2176-2 |
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 |
From: RA MSO <[email protected]>
Sent: Wed, 16 Apr 2025 11:47:28 +0000
To: Kristupas Žegunis <[email protected]>
Subject: Vs: Medical devices registration
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.
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
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, 14. aprill 2025 08:46
Adressaat: Karl Kalev Türk <[email protected]>; MSO (Arhiiv) <[email protected]>
Teema: Medical devices registration
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Good morning,
Wanted to register medical devices that our company distributes in Estonia but find the system a bit complicated. Couls you please provide the guidelines how properly register the products in https://msa.sm.ee/
Sincerely,
______________
Kristupas Žegunis
BALTIJOS REGIONO VERSLO VYSTYMO VADOVAS / BUSINESS DEVELOPMENT MANAGER IN BALTICS REGION
Mob. +37065800345
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Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Küsimused | 12.05.2025 | 1 | MSO-2/2176-8 🔒 | Väljaminev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 12.05.2025 | 1 | MSO-2/2176-7 🔒 | Sissetulev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 02.05.2025 | 3 | MSO-2/2176-6 🔒 | Väljaminev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 02.05.2025 | 3 | MSO-2/2176-5 🔒 | Sissetulev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 29.04.2025 | 1 | MSO-2/2176-4 | Väljaminev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 29.04.2025 | 1 | MSO-2/2176-1 | Sissetulev kiri | ra | UAB „BIOMEDIKA“ |
Küsimused | 29.04.2025 | 1 | MSO-2/2176-3 | Sissetulev kiri | ra | UAB „BIOMEDIKA“ |