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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

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.

01.09.2024

Combined studies

New forms and a new information sheet for submissions to Swissmedic

14.08.2024

New transitional provisions

EU IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

New / updated documents

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 31.10.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 731 kB, 31.10.2024)

BW600_00_017e_MB Combined studies (PDF, 348 kB, 31.10.2024)

BW630_30_008e_MB Notifications devitalised human tissue (PDF, 281 kB, 22.10.2024)

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 08.10.2024)

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, 08.10.2024)

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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 04.11.2024

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