Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/5145-2 |
| Registreeritud | 15.05.2024 |
| Sünkroonitud | 16.05.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Sim&Cure |
| Saabumis/saatmisviis | Sim&Cure |
| Vastutaja | Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Wed, 15 May 2024 07:34:12 +0000
To: "[email protected]" <[email protected]>
Cc: "[email protected]" <[email protected]>; "[email protected]" <[email protected]>
Subject: Ed: Advertising requirements for medical devices in Estonia
Dear Ines Mohand Cherif
Thank you for your enquiry.
You are correct – the Advertising Act applies to medical devices.
Additionally, the requirements laid out in articles 7 in EU regulations 2017/745 and 2017/746 are also applicable.
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
Saatja: Ravimiamet <[email protected]>
Saatmisaeg: kolmapäev, 15. mai 2024 08:36
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: FW: Advertising requirements for medical devices in Estonia
Tere
Edastan e-kirja.
Heade soovidega
Kärolin Jenas
Ravimiamet
üldosakonna dokumendihalduse spetsialist
Telefon 737 4140
[email protected]
Nooruse 1
50411 Tartu
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 received. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.
From: Ines MOHAND-CHERIF <[email protected]>
Sent: teisipäev, 14. mai 2024 16:42
To: Ravimiamet <[email protected]>
Cc: Wael BOUAZZAOUI <[email protected]>; Colette MAURIN <[email protected]>
Subject: Advertising requirements for medical devices in Estonia
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Hi,
We are a medical device manufacturer based in France and we are looking for the advertising/promotional rules for medical devices in Estonia. I only found the Advertising Act on the ministry website. Is chapter 2 "General requirements for advertising" of this act applicable for medical devices ? If not, can you please provide me with this information?
Thank you in advance,
Regards,
Ines MOHAND CHERIF
Regulatory Affairs & Quality Assurance Engineer
Sim&Cure
95 rue Pierre Flourens, Bât H
34090 Montpellier, France
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 15.05.2024 | 1 | 11.1-12/24/5145-1 | Sissetulev dokument | ta | Sim&Cure |