Kiri

Dokumendiregister Terviseamet
Viit 11.1-2/24/11773-3
Registreeritud 20.12.2024
Sünkroonitud 23.12.2024
Liik Sissetulev dokument
Funktsioon 11.1 Turustamise järgne järelevalve (post-marketing surveillance)
Sari 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks
Toimik 11.1-2/2024
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat UAB" Innovative Pharma Baltics"
Saabumis/saatmisviis UAB" Innovative Pharma Baltics"
Vastutaja Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

Re_ Re_ Change of contact person.msg
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From: Lauryna Pudžiuvelytė <lauryna@innovative.lt>
Sent: Tue, 03 Dec 2024 14:28:30 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Subject: Re: Re: Change of contact person

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


 
Dear Karl, 

Thank you for the information. Now it is more clear. 
About the submission form: Are there any important fields that are mandatory to fill? 

My second question is after I fill and submit this form about medical devices and it is approved, should we place the medical devices in the Estonian market, or do we need something else to do this? 

Thank you for all your help. It is valuable. 

Have a nice day. 


Dr. Lauryna Pudžiuvelytė

Farmacininkė, tyrėja Pharmacist, Researcher


UAB" Innovative Pharma Baltics"
Mokslininkų g. 6a Vilnius, Lietuva
Tel.: +37061236457
El. p.: lauryna@innovative.lt

www.innovative.lt



2024-10-03, kt, 14:57 Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee> rašė:

Dear Lauryna,

 

Thank you for your letter.

 

Please select the application named Notify about medical device distribution in Estonia “. The application „Notify about placing medical device on the market“ is only for Estonia-based manufacturers or authorized representatives who are placing their medical devices on the market for the first time.

 

Regarding the "Notified Body number" field in the application, you may leave it blank. Although there is a red asterisk indicating that the field appears to be mandatory, it is not. You can still submit the application with this field left empty.

 

Do not hesitate to contact me should you require any additional information or have further questions.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

 

Republic of Estonia

Terviseamet | Health Board

+372 794 3500

info@terviseamet.ee
www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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: Lauryna Pudžiuvelytė <lauryna@innovative.lt>
Saatmisaeg: neljapäev, 3. oktoober 2024 11:49
Adressaat: Karl Kalev Türk <karl.kalev.turk@terviseamet.ee>
Teema: Fwd: [SUSPICIOUS URL INSIDE]Re: Change of contact person

 

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


 

Dear Karl, 

 

I saw that everything was OK. 

So, I have a question. My company would like to place the medical devices in Estonia. So, I have to fill this field of the information: Notify about placing medical device on the market, yes? 

Our medical devices are class I, but in the application form there is a mandatory place for a notified body number. 

 

 

 

Have a nice day. 

 

Saatja on pildi eemaldanud.

Dr. Lauryna Pudžiuvelytė

Farmacininkė, tyrėja Pharmacist, Researcher


UAB" Innovative Pharma Baltics"
Mokslininkų g. 6a Vilnius, Lietuva
Tel.: +37061236457
El. p.: lauryna@innovative.lt

www.innovative.lt

 

 

2024-09-09, pr, 11:02 TA automaatvastus <automaatvastus@terviseamet.ee> rašė:

Tere

 

Teie kiri on jõudnud Terviseameti meditsiiniseadmete osakonna e-posti aadressile MSO@terviseamet.ee

 

Teile vastatakse:

• teabenõude korral 5 tööpäeva jooksul

• selgitustaotluse puhul 30 päeva jooksul

 

Lugupidamisega

 

meditsiiniseadmete osakond

Terviseamet

MSO@terviseamet.ee

 

Dear Sir/Madam,

 

Medical Devices Department, Health Board has received your e-mail sent to MSO@terviseamet.ee

 

Your message shall be replied:

• a request for information within 5 business days

• a request for explanation within 30 calendar days

 

Best regards,

 

Medical Devices Department

Estonian Health Board

MSO@terviseamet.ee

 

 

Seosed

Nimi K.p. Δ Viit Tüüp Org Osapooled
Kiri 20.12.2024 3 11.1-2/24/11773-4 Väljaminev dokument ta UAB" Innovative Pharma Baltics"
Kiri 13.11.2024 1 11.1-2/24/11773-2 Väljaminev dokument ta lauryna@innovative.lt
Kiri 13.11.2024 1 11.1-2/24/11773-1 Sissetulev dokument ta lauryna@innovative.lt