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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

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

16.07.2021

Update to Field Safety Notice from Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices – recommendations from professional associations

Recommendations of the professional societies SGP and SSSSC published

Announcements

15.04.2024

Paclitaxel-coated balloons and paclitaxel-eluting stents

Potential association with increased mortality not confirmed

08.02.2024

swissdamed – Swiss Database on Medical Devices

The “going-live” date being deferred to the 2nd half of 2024

29.01.2024

Checkliste zur Überprüfung eines Berichts zur Revalidierung eines Reinigungs- und Desinfektionsprozesses mit RDG für chirurgische Instrumente oder einer Grossraum-Waschanlage (CWA) in Gesundheitseinrichtunge

This checklist (only in German and French) serves as an aid for professionals who check the annual validation reports of instrument washer disinfectors and trolley washer disinfectors.

09.01.2024

Medical devices with certification from the former notified body ECM (Aachen DE, identification number 0481)

Information and targeted check of Swiss authorised representatives

18.12.2023

Devices manufactured and used in healthcare institutions

General information and notes on in-house devices according to MedDO and IvDO

07.11.2023

New information on submitting vigilance reports for medical devices

Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)

New / updated documents

BW630_30_007e_MB Medical Device Software (PDF, 499 kB, 10.04.2024)

BW690_00_002e_WL Export Certificates (PDF, 3 MB, 27.03.2024)

IN640_00_001e_MB Information sheet MDS requirements for corrective and preventive action plans (PDF, 836 kB, 01.02.2024)

Permanent link of this page
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 15.04.2024

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