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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

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

16.07.2021

Update to Field Safety Notice from Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices – recommendations from professional associations

Recommendations of the professional societies SGP and SSSSC published

28.06.2021

Philips Respironics: Worldwide safety notice for specific ventilators, sleep apnoea and respiratory care devices

Philips Respironics announces a repair and replacement programme for sound abatement foam components used in certain respiratory devices

Announcements

30.05.2022

New regulations on in vitro diagnostic medical devices

Online information event
Save the Date: 3 November 2022

26.05.2022

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)

26.05.2022

Performance studies with IVD

New legal requirements for performance studies with IVDs since 26 May 2022.

07.04.2022

Roundtable on Medical Technology (RTMT)

Interested associations/organisations can apply to participate in the RTMT using the application for nomination form.

03.03.2022

Update of the information sheet - Unique identification number (CHRN – Swiss Single Registration Number)

Additional information on the unique identification number (CHRN – Swiss Single Registration Number)

01.03.2022

Medical devices database

Please note the information on the medical devices database

Updated PDF forms

BW690_00_001e_VL FSC-Example of a product list (PDF, 338 kB, 13.06.2022)

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 16.06.2022

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