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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

10.11.2022

More than 700 participants at the information event on the new in vitro diagnostic medical devices regulation

Successful Swissmedic online event on 3 November 2022

08.11.2022

Export certificates (Free Sales Certificates)

Adaptation of the ordering process from 01.01.2023

03.10.2022

Swissmedic inspects Swiss authorised representatives (CH-REP)

Swissmedic carried out systematic, focused inspections of Swiss authorised representatives (CH-REP) in the first half of 2022 to check their implementation of the provisions in the market.

13.09.2022

Medical devices database

Please note the information on the medical devices database

05.09.2022

New regulations on in vitro diagnostic medical devices

Online information event
Thursday, 3 November 2022

30.06.2022

Roundtable on Medical Technology (RTMT)

New structure: On 27.06.2022, the Roundtable on Medical Technology (RTMT) successfully started in its new composition.

Updated PDF forms

MU680_10_014d_FO Vigilance-Kontaktperson für Medizinprodukte - Mutation (PDF, 1 MB, 30.11.2022)Document only available in German, French or Italian

IN615_30_001d_MB Einzelheiten über die Instandhaltung von MEP durch Dritte (PDF, 159 kB, 25.10.2022)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 30.09.2022)

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 28.09.2022)

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, 28.09.2022)

BW610_10_021e_FO Authorisation clinical investigation MD (PDF, 1 MB, 01.09.2022)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 01.09.2022)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 01.09.2022)

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.09.2022)

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 01.12.2022

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