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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

01.07.2024

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Academic studies: Application for fee reduction

01.07.2024

Expiry of COVID-19 Ordinance 3

Dispensing of coronavirus self-tests still possible from 1 July 2024

26.06.2024

Go-live for the swissdamed Actors module

The first module of the swissdamed medical devices database goes online in August.

07.06.2024

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.

16.05.2024

Announcements on performance studies with vitro diagnostic medical devices

MDCG 2024-04 – New guidance document and table for safety reporting during performance studies.

15.04.2024

Paclitaxel-coated balloons and paclitaxel-eluting stents

Potential association with increased mortality not confirmed

New / updated documents

IN615_30_836d_MB Pflichten von Fachanwendern und Dritten im Zusammenhang mit der Durchführung der Instandhaltung von Medizinprodukten (PDF, 602 kB, 03.07.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 894 kB, 01.07.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 865 kB, 01.07.2024)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2024)

BW610_10_030e_VL Application fee reduction selfdeclaration (DOCX, 366 kB, 01.07.2024)

BW690_00_001e_VL FSC-Example of a product list (PDF, 481 kB, 21.06.2024)

IN615_10_004d_CL Checkliste für die Inspektion von Systemen der Vigilance betreffend Medizinprodukten (PDF, 1 MB, 20.06.2024)(Notification of serious incidents in connection with medical devices and safety notices) Document only available in German, French or Italian

IN615_00_005d_CL Checkliste für die Inspektion der Instandhaltung von Medizinprodukten (PDF, 1 MB, 23.05.2024)

IN615_20_002d_CL Checkliste für die Inspektion von Aufbereitungseinheiten für Medizinprodukte (AEMP) (PDF, 7 MB, 01.05.2024)

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Contact

Swissmedic
Medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 25.07.2024

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