Küsimused

Dokumendiregister	Ravimiamet
Viit	MSO-8/2382-1
Registreeritud	08.05.2025
Sünkroonitud	09.05.2025
Liik	Sissetulev kiri
Funktsioon	MSO Meditsiiniseadmed
Sari	MSO-8 Turujärelevalvega seotud nõustamine
Toimik	MSO-8/2025
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	Bain
Saabumis/saatmisviis	Bain
Vastutaja	Piret Põiklik (RA, Meditsiiniseadmete osakond)
Originaal	Ava uues aknas

Failid

Consulting the procedure of registration of medical devices in Estonia.msg

From: 李诗兰 <[email protected]>
Sent: Wed, 23 Apr 2025 03:44:08 +0000
To: mso <[email protected]>
Subject: Consulting the procedure of registration of medical devices in Estonia

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

Dear Sir or Madam,

We are a Chinese manufacturer of medical devices ,which got CE marking.

I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market.

If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia.

Thank you very much for your time and assistance. Looking forward to your reply.

Best Regards,

Wendy Li

Regulatory Affairs

Bain Medical Equipment (Guangzhou) Co., Ltd.

Tel: +86 020 66856868-290

Fax: 86-20-32067500

Email:

[email protected]

Website:http://www.bainmedical.com/

李诗兰<[email protected]> 在 2025年4月23日周三 11:42 写道：