Sissetulev kiriAvalik
Pöördumine
Sotsiaalministeerium · 20. oktoober 2022
- Viit
- 1.4-2/3446-1
- Registreeritud
- 20. oktoober 2022
- Dokumendi liik
- Sissetulev kiri
- Adressaat
- European Commission
- Saabumis/saatmisviis
- e-post
- Funktsioon
- 1.4 EL otsustusprotsess ja rahvusvaheline koostöö
- Sari
- 1.4-2 Rahvusvahelise koostöö korraldamisega seotud kirjavahetus (Arhiiviväärtuslik)
- Toimik
- 1.4-2/2022
- Vastutaja
- Kersti Esnar (Sotsiaalministeerium, Kantsleri vastutusvaldkond, Terviseala asekantsleri vastutusvaldkond, Tervisesüsteemi arendamise osakond)
Sisu (failidest)
Saatja: <[email protected]>
Saadetud: 20.10.2022 10:22
Adressaat: <[email protected]>
Koopia: <[email protected]>
Teema: Supply of HSC collection kits
Dear competent authorities for tissues and cells,
In the context of our concerns on supply disruption for HSC collection
kits, we herewith want to inform you that the German authority for
medical devices (BfArM) has granted, on 16 September 2022, a derogation
to BioAccess which allows the import (into Germany) of BioAccess
collection kits without CE mark. This national derogation is valid until
30 September 2023.
For further information, please contact directly the national competent
authorities for medical devices.
We hope herewith to have you informed sufficiently.
With kind regards,
The SoHO team.
European Commission DG SANTE (Health and Food Safety)
Unit D2 Medical Products: quality, safety, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium