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Terviseamet · 15. detsember 2022
Seotud ettevõtted
- Viit
- 11.2-4/22/9812-1
- Registreeritud
- 15. detsember 2022
- Dokumendi liik
- Sissetulev dokument
- Adressaat
- Brilitas Pharmaceuticals EU OÜ
- Saabumis/saatmisviis
- e-post
- Funktsioon
- 11.2 SULETUD 2025 Turustamise eelne järelevalve (pre-marketing surveillance)
- Sari
- 11.2-4 Erandid vastavushindamismenetlusest, taotlused ja kirjavahetus
- Toimik
- 11.2-4/2022
- Vastutaja
- Kristina Kübar (TA, Peadirektori vastutusvaldkond, Meditsiiniseadmete osakond)
- Lahendamise tähtaeg
- 14. jaanuar 2023
Failid
Sisu (failidest)
Saatja: Riigikantselei <[email protected]>
Saadetud: 15.12.2022 10:56
Adressaat: TA Info <[email protected]>
Koopia: <[email protected]>
Teema: FW: Notified Body
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Tere
Edastame kirja vastavalt kuuluvusele Terviseametile.
Lugupidamisega
Riigikantselei
Rahukohtu 3 | 15161 Tallinn
693 5555 | www.riigikantselei.ee | Stenbocki maja | @StenbockiMaja
From: Mỹ Linh Trương Phạm <[email protected]>
Sent: Thursday, December 15, 2022 10:46 AM
To: Riigikantselei <[email protected]>
Subject: Notified Body
Dear Health Board Terviseamet,
We are Brilitas Pharmaceuticals EU OÜ, with registration code is 16618699.
Brilitas plans to become a Notified Body that conducts assessment of the conformity of medical devices before it is
put on the market. However, this right is granted by the competent authority.
Brilitas would like to know the government regulations on eligibility and application process to be designated a
Notified Body.
We look forward to response from the Health Board Terviseamet.
In Peace and Happiness,
Best regards,
Lin.
Truong Pham My Linh (Ms.)
Legal Administration
Brilitas Pharmaceuticals Joint Stock Company
Phone: (+084) 902 850 112
Email: [email protected]