Sissetulev kiriAvalik
Küsimused
Ravimiamet · 28. märts 2025
- Viit
- MSO-8/1634-1
- Registreeritud
- 28. märts 2025
- Dokumendi liik
- Sissetulev kiri
- Adressaat
- Abbott Medical
- Saabumis/saatmisviis
- e-post
- Funktsioon
- MSO Meditsiiniseadmed
- Sari
- MSO-8 Turujärelevalvega seotud nõustamine
- Toimik
- MSO-8/2025
- Vastutaja
- Maarika Ojala (RA, Meditsiiniseadmete osakond)
Sisu (failidest)
Saatja: Gilbertson, Michael L <[email protected]>
Saaja: Ravimiamet, MSO (Arhiiv), RA MSO, Jiwatrakan, Pin
Teema: Abbott Medical - Responsibility for Medical Devices in Estonia
Dear Sir/Madam,
We have recently become aware that from 01-Jan-2025 the administrative responsibilities of the Estonian Health Board related to medical devices have been transferred to the Estonian State Agency of Medicines.
As a Medical Device Manufacturer, to avoid any missed responsibilities of ours.
Please can we ask for your support/response to the following questions?
1. Was there a time period where both the old ([email protected] <mailto:[email protected]> ) and new ([email protected] <mailto:[email protected]> ) are active at the same time? If so, what is the timeframe?
2. Has the [email protected] <mailto:[email protected]> email been decommissioned? If so, should we resubmit reports from 01-Jan-2025 until the present day to [email protected] <mailto:[email protected]> ?
I look forward to your response.
Kind regards,
Luke
Luke Gilbertson
Senior Regulatory Compliance Specialist (EMEA)
Abbott, Elder House
Blythe Valley Business Park
Solihull, UK, B90 8AJ
O:
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M:
+44 (0) 7785 692 474
E:
[email protected] <mailto:[email protected]>
[email protected] <mailto:[email protected]>