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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

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)

21.08.2019

Sicherheitsmitteilung: Rückruf von Unterarmgehstützen des Modells ADVANCE – Herdegen Paris, Chelles

Brechen des Handgriffs oder der Armauflagefläche

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

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

02.06.2020

Questions and Answers (Q&A): document on the new form for reporting serious incidents

29.05.2020

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

07.04.2020

Implementation of the new medical devices regulations

COVID-19 pandemic: European Commission postponing introduction of the MDR by one year

Updated PDF forms

24.06.2020

BW630_10_002e_MB Single Registration Number - SRN FAQ (PDF, 171 kB, 24.06.2020)

MU500_00_014e_MB Medical devices/ COVID-19 (PDF, 378 kB, 24.06.2020)

26.05.2020

BW610_10_021e_FO Clinical trials with medical devices Application for authorisation (PDF, 1 MB, 26.05.2020)

BW610_20_021e_FO Clinical trials with medical devices: Amendment concerning authorisation and safety measures (PDF, 1 MB, 26.05.2020)

BW610_20_022e_FO Clinical trials with medical devices Notifiable amendment and report (PDF, 1 MB, 26.05.2020)

BW610_20_023e_FO Clinical trials of medical devices: Serious adverse events and deficiencies in Switzerland (PDF, 1 MB, 26.05.2020)

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 30.06.2020

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