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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

29.04.2025

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

Safety notice

Announcements

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

17.02.2025

Swissmedic assessment of post-market surveillance documentation

Swissmedic assessed the compliance with the post-market surveillance requirements for 30 legacy devices in risk classes IIa and higher.

03.02.2025

Surveillance of the use of medical devices for anti-wrinkle injections (“fillers”)

The cantonal therapeutic product authorities and the Office for Health of Liechtenstein, in collaboration with Swissmedic, inspected the use of fillers in 82 clinics, medical practices, and cosmetic studios.

31.01.2025

New Swiss Good Practice in the maintenance of medical devices

The revised Swiss Good Practice in the maintenance of medical devices is here! The central reference document for maintenance of medical devices has been updated and published in January. It is now available in German and French.

New / updated documents

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 26.05.2025)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 23.05.2025)

MU680_20_009e_WL Incident economic operators (PDF, 385 kB, 20.05.2025)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 09.05.2025)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 09.05.2025)

BW630_30_829d_WL Wegleitung In-house Medizinprodukte (PDF, 303 kB, 01.05.2025)

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 26.05.2025)

BW690_00_002defi_FO Orders for export certificates for medical devices subject to old legislation as well as DEVIT products and IVD (PDF, 1 MB, 03.04.2025)

BW617_00_003e_MB Derogation MEP (PDF, 279 kB, 26.03.2025)

BW690_00_001e_VL FSC-Example of a product list (PDF, 287 kB, 25.03.2025)

BW690_00_002e_WL Export Certificates (PDF, 426 kB, 19.03.2025)a new version of this document will be published soon; starting 26th May 2025, please refer to the German document until the English version is published

BW630_40_870e_WL swissdamed Privacy Notice and Terms of Use (PDF, 297 kB, 06.03.2025)

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 28.05.2025

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