Selgitustaotlus

Dokumendiregister Terviseamet
Viit 11.3-3/24/10271-1
Registreeritud 11.10.2024
Sünkroonitud 14.10.2024
Liik Sissetulev dokument
Funktsioon 11.3 Meditsiiniseadmete alane koostöö Euroopa komisjoni, sõsarasutuste, ministeeriumide ja teiste ametite/inspektsioonidega
Sari 11.3-3 Üldine kirjavahetus (Koostöö riigiasutustega (ministeeriumid, ametid, inspektsioonid, jms)
Toimik 11.3-3/2024
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat Fortrea Development Ltd
Saabumis/saatmisviis Fortrea Development Ltd
Vastutaja Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

E-kiri.eml
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Good morning,

 

Hope this email finds you well.

 

Could you please confirm if the provided information (in green color) related to the Safety Reporting requirements in the context of Medical Device Clinical Trials in Estonia is up to date.

 

 

·         Domestic SADEs occurring within study (yes/no)? Yes

·         Foreign SADEs occurring within study (yes/no)? Yes

·         SADEs from other studies with same study device  / Cross-reports (yes/no)? No

o   SADE Reporting Form: Clinical Investigation Summary Safety Report Form

o   SADE Reporting Methodelectronic

o   SADE Reporting Format: electronic

             Electronic reporting destination: mso@terviseamet.ee

·         Additional/Exceptions to expedited 7/15 SADE reports? (Yes/No) if yes, please see special reporting requirements: Yes - Serious public health threat: 2 days. Death or UNANTICIPATED serious deterioration in state of health: 7 days. Others: 30 days

·         Periodic Line Listing required? (Yes/no) if yes, please confirm: No

o   Frequency for Line Listing: NA

o   Reporting Timeline for Periodic Line Listing (days after DLP) NA

o   Periodic Line Listing Reporting Method (e.g. e-mail, N/A, etc.) NA

o   Periodic Line Listing Format: NA

Destination for electronic Line Listing: NA

·         Annual Report required? (yes/no) if yes, please confirm: No

o   Reporting Timeline for Annual Report (days after DLP) NA

o   Annual Report Reporting Method (e.g. courier, CESP, email etc) NA

o   Annual Report Reporting Format (e.g. paper, CD-ROM, pdf, eCTD etc) NA

Destination for electronic Annual Report submission: NA

  • Periodic Report Special reporting requirements: NA

o   Translation required for safety reports? No

  • Translation requirements - Language and report/information to be translated? (if yes, please specify the language) NA

 

 

 

Thank you in advance for your time and support.

 

 

Best Regards,

 

Aleksandra Chevalier, MPharm

Drug Safety Associate, Drug Safety

 

E: aleksandra.chevalier@fortrea.com
fortrea.com
Fortrea Development Ltd 

 

B04571E5 

 

 

 

 

 



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