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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

03.07.2024

Counterfeit medical device CHONDROGRID® - INJECTABLE COLLAGEN HYDROLYSATE - 1 BTL 4MG from Bioteck S.p.A.

Safety notice

Announcements

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.

01.01.2025

Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs) and the Medical Devices Ordinance

The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025

20.12.2024

Updated information on BIA-ALCL

Reports on breast-implant associated-anaplastic large cell lymphoma (BIA-ALCL) in Switzerland 2012–2024

07.10.2024

Swissmedic inspections: Potential for improvement in hospitals

Annual report

New / updated documents

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)

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

MU680_10_007e_WL Vigilance contact person for medical devices (PDF, 573 kB, 18.02.2025)

MU680_20_008e_WL Incident report user (PDF, 474 kB, 18.02.2025)

MU680_21_010e_WL FSCA economic operators (PDF, 327 kB, 05.02.2025)

MU680_20_009e_WL Incident economic operators (PDF, 822 kB, 05.02.2025)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 30.01.2025)

IN615_00_005d_CL Checkliste für die Inspektion der Instandhaltung von Medizinprodukten (DOCX, 2 MB, 30.01.2025)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 20.01.2025)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 20.01.2025)

BW630_30_010e_MB FAQ on in vitro diagnostic medical device notifications (PDF, 326 kB, 17.01.2025)

MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 600 kB, 01.01.2025)

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 1 MB, 01.01.2025)

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 25.03.2025

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