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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

03.07.2024

Counterfeit medical device CHONDROGRID® - INJECTABLE COLLAGEN HYDROLYSATE - 1 BTL 4MG from Bioteck S.p.A.

Safety notice

17.04.2023

Counterfeit BIO-GEN CORTICAL BONE substitutes from Bioteck S.p.A.

Safety notice

30.05.2022

Latest information on the Field Safety Notice issued by Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices

Information on the status of ongoing corrective actions

Announcements

14.08.2024

New transitional provisions

EU IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

06.08.2024

swissdamed “Actors” module now available

The first module of the swissdamed medical devices database is online today.

01.07.2024

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Academic studies: Application for fee reduction

01.07.2024

Expiry of COVID-19 Ordinance 3

Dispensing of coronavirus self-tests still possible from 1 July 2024

26.06.2024

Go-live for the swissdamed Actors module

The first module of the swissdamed medical devices database goes online in August.

07.06.2024

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.

New / updated documents

MU600_00_017e_MB 3D printers medical devices (PDF, 314 kB, 13.08.2024)

BW630_40_870e_WL swissdamed Privacy Notice and Terms of Use (PDF, 299 kB, 06.08.2024)

BW630_40_871e_WL swissdamed Service Agreement (PDF, 298 kB, 06.08.2024)

BW630_40_001e_HB Handbook swissdamed User Guide Actors (PDF, 2 MB, 31.07.2024)

IN615_30_836d_MB Pflichten von Fachanwendern und Dritten im Zusammenhang mit der Durchführung der Instandhaltung von Medizinprodukten (PDF, 602 kB, 03.07.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 894 kB, 01.07.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 865 kB, 01.07.2024)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2024)

BW610_10_030e_VL Application fee reduction selfdeclaration (DOCX, 366 kB, 01.07.2024)

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www.swissmedic.ch/md-en

Contact

Swissmedic
Medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 19.08.2024

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