Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/7978-2 |
| Registreeritud | 06.08.2024 |
| Sünkroonitud | 07.08.2024 |
| 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 | Fortrea |
| Saabumis/saatmisviis | Fortrea |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Tue, 06 Aug 2024 12:02:33 +0000
To: "[email protected]" <[email protected]>
Cc: "Kota; Narendrakumar" <[email protected]>; "Mukherjee; Dalina" <[email protected]>; "Chevalier; Aleksandra" <[email protected]>
Subject: Vs: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
Dear Sai Kiran,
Thank You for Your enquiry.
The medical device regulations do not specify such term as ’aggregate report’. Please specify the questions nature as per medical device regulations terminology.
All the best,
Merili Saar-Abroi
peaspetsialist
meditsiiniseadmete osakond
+372 554 3041
[email protected] | [email protected]
| Terviseamet +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
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From: Topa, Sai Kiran <[email protected]>
Sent: kolmapäev, 31. juuli 2024 14:01
To: Ravimiamet <[email protected]>
Cc: Kota, Narendrakumar <[email protected]>; Mukherjee, Dalina <[email protected]>; Chevalier, Aleksandra <[email protected]>
Subject: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
Dear Sir/ Madam,
Hope this email finds you well.
Could you please provide us the contact information (preferably email) for regulatory authority and Pharmacovigilance for Estonia.
In addition, could you please provide the following information for post-marketing Medical device Clinical Trials in Estonia.
Post-marketing Medical Device Clinical Trials (AGGR requirements):
- Destination (Agency Name):
- Requirements:
- Aggregate Report Type:
- Timelines:
- Translation required for Aggregate Reports in regional language ? (Yes/No)
Thanks & Regards
Sai Kiran Topa
Safety Science Analyst
M: +91 7093615048 | fortrea.com
Fortrea
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