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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

09.07.2020

Risiko für Medikationsfehler von Dosisberechnungssoftware

aufgrund einer geänderten Bezeichnung der Stärke von Onivyde

25.11.2019

Update to the safety notice: Securidrap from the company Mulliez-Flory

Warning against use

28.10.2019

UPDATE zur Sicherheitsmitteilung: COCUNE – Waschhandschuh (parfümiert/unparfümiert) der Firma Stöpler Instrumenten & Apparaten B.V. (NL)

Call for Experts

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)

Published on: 30/09/2019

Announcements

08.09.2020

Medical devices in the context of the Covid-19 pandemic

Information sheet on protective masks, gloves and other personal protective equipment as well as hand sanitisers and coronavirus tests

01.08.2020

Authorisations for non-conforming medical devices

09.07.2020

Federal Council approves new MedDO and ClinO-MD

29.06.2020

New coronavirus: Swissmedic issues warning about non-conforming face masks

Potentially inferior-quality products are increasingly being offered in Switzerland too

29.06.2020

Placing on the market of important non-conforming medical devices for combating the COVID-19 pandemic

Exemptions for non-conforming medical devices

24.06.2020

UPDATE: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents

Potential association with increased mortality

Updated PDF forms

01.09.2020

MU500_00_015e_MB Information sheet Face masks for the public (PDF, 494 kB, 01.09.2020)

19.08.2020

BW630_10_002e_MB Single Registration Number - SRN FAQ (PDF, 207 kB, 11.08.2020)

MU510_00_006e_MB Materiovigilance – Manufacturer reports (PDF, 226 kB, 30.06.2020)

01.08.2020

BW617_00_004e_MB Authorisations for non-conforming medical devices (PDF, 485 kB, 01.08.2020)

30.07.2020

BW540_00_003e_MB Export certificates and manufacturing certificates for medical devices (PDF, 925 kB, 30.07.2020)

27.07.2020

MU510_00_007e_MB Materiovigilance FSCA (PDF, 449 kB, 27.07.2020)

16.07.2020

bw530_00_010e_FO Notification according to Art. 6 MedDO for Class I medical devices and systems or treatment units according to MDR (PDF, 1 MB, 16.07.2020)

Permanent link of this page
www.swissmedic.ch/md-en

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 01.09.2020

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