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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

09.07.2025

Warning concerning Smileie aligners

Swissmedic recommends that Smileie aligners should henceforth no longer be used

29.04.2025

Counterfeit of the medical device SmartBone®, bone substitute, from lndustrie Biomediche lnsubri SA

Safety notice

Announcements

08.08.2025

Information sheet systems and procedure packs

The Information sheet outlines the obligations for the assembly and labelling of systems and procedure packs, as well as the associated obligations of economic operators in Switzerland and Liechtenstein

08.08.2025

Implementation in Switzerland of EU Commission Implementing Regulation on instructions for use in electronic form

Swissmedic is adopting the new EU requirements for the electronic provision of instructions for use for medical devices with immediate effect

08.07.2025

Schweizerische Gute Praxis zur Aufbereitung von Medizinprodukten in ambulanten Gesundheitseinrichtungen (GPA-ambulant)

Informationen an die interessierten Verbände und Fachgesellschaften

09.05.2025

New version of the form (MIR) for reporting serious incidents

In accordance with the EU publication, this form V7.3.1 will also be mandatory for incidents in Switzerland as of November 2025

01.05.2025

Focus campaign 2025 to check compliance with importer obligations

Swissmedic will be launching a focus campaign in 2025, to check compliance with importer obligations.

03.04.2025

Swissmedic joins the Management Committee of the IMDRF

Swissmedic's appointment to the Management Committee of the IMDRF strengthens international cooperation and supports efficient regulation in Switzerland

New / updated documents

MU600_00_018e_MB Systems and procedure packs (PDF, 379 kB, 04.08.2025)

MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (PDF, 229 kB, 21.07.2025)(mandatory from November 2025)

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 08.08.2025

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