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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

17.04.2023

Counterfeit BIO-GEN CORTICAL BONE substitutes from Bioteck S.p.A.

Safety notice

30.05.2022

Latest information on the Field Safety Notice issued by Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices

Information on the status of ongoing corrective actions

Announcements

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

03.10.2024

GPA Korrigendum

Swissmedic publishes a corrigendum for the «schweizerische Gute Praxis zur Aufbereitung von Medizinprodukten»

27.09.2024

swissdamed: Deadline on 13 November 2024

All registered economic operators are required to validate their data

18.09.2024

Request to review devices that comply with the old legislation

In the context of our market surveillance activities, we would like to draw your attention to the facts concerning the transitional provisions for legacy devices described in the attachment and kindly ask you to check your products with regard to this matter.

New / updated documents

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)

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)

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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 20.01.2025

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