Vastuskiri

Dokumendiregister Terviseamet
Viit 11.2-1/24/2111-2
Registreeritud 23.02.2024
Sünkroonitud 26.03.2024
Liik Väljaminev dokument
Funktsioon 11.2 Turustamise eelne järelevalve (pre-marketing surveillance)
Sari 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus)
Toimik 11.2-1/2024
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat Medinet
Saabumis/saatmisviis Medinet
Vastutaja Merili Saar (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

Vs_ Company distributor.msg
image001.jpg

From: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Sent: Fri, 23 Feb 2024 07:45:52 +0000
To: "info@medinet.lt" <info@medinet.lt>
Subject: Vs: Company distributor

Dear Rūta,

Thank You for Your e-mail.

 

All national provisions supplementing the MDR are described in the Estonian Medical Devices Act (MDA) and its implementing acts.

 

Prior to distributing Your device on the market of Estonia, the manufacturer must place the devices on the market in accordance with the requirements of the MDR. After that, distribution notification is mandatory for devices belonging to classes IIa, IIb or III by the MDR or classes B, C or D by the IVDR according to the MDA § 26 (4):

 (4) Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

 

Notification of class I medical device distribution is considered voluntary.

 

The distribution notification can be made through Estonian Medical Device Database (EMDDB). This procedure is free of charge.

 

Any other aspects you might be interested in is described in the MDA.

Should there be any further questions, please do not hesitate to contact us again.

 

All the best,

Merili Saar

Chief Specialist

Department of Medical Devices

Phone +372 554 3041

merili.saar@terviseamet.ee  | mso@terviseamet.ee

Terviseamet | Health Board

+372 794 3500

info@terviseamet.ee
www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

 

 

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: info@medinet.lt <info@medinet.lt>
Saatmisaeg: kolmapäev, 21. veebruar 2024 12:20
Adressaat: TA Info <info@terviseamet.ee>
Teema: Company distributor

 

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


 

Dear Health Board of Estonia,

 

We are company - distributor for producer of medical devices.

Please provide all information for entering/registration into Estonian market. 

Company registration needs, Items on reimbursement list. Prescribers responsibilities. 

 

Kind Regards, 

Rūta Pukanasė-CEO

www.medinet.lt

 

Seosed

Nimi K.p. Δ Viit Tüüp Org Osapooled
Selgitustaotlus 21.02.2024 35 11.2-1/24/2111-1 Sissetulev dokument ta Medinet