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
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Fri, 23 Feb 2024 07:45:52 +0000
To: "[email protected]" <[email protected]>
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
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] 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: [email protected] <[email protected]>
Saatmisaeg: kolmapäev, 21. veebruar 2024 12:20
Adressaat: TA Info <[email protected]>
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
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Selgitustaotlus | 21.02.2024 | 35 | 11.2-1/24/2111-1 | Sissetulev dokument | ta | Medinet |