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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Inhouse News

30.12.2021

Update of the information sheet on the obligations of economic operators

Swissmedic has updated the information on the indications of the Swiss authorised representative and the importer on the product and its accompanying documents

07.09.2021

More than 1,600 participants at the information event on the new medical devices regulation

Successful Swissmedic online event on 2 September 2021

06.01.2022

Obligations for authorised representatives, importers and distributors

Revision of medical devices law - Overview of the obligations of Swiss authorised representatives, importers and distributors

26.05.2021

New regulations applicable to medical devices as of 26 May 2021

Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU

Warnings and counterfeits

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

28.05.2021

Sicherheitsmitteilung: Rückruf bestimmter Chargen von Bausch + Lomb Kontaktlinsenlösungen

augenspülender und augenbefeuchtender Produkte

Announcements

17.01.2022

Good practice for the reprocessing of medical devices for Swiss health facilities

Publication of the "Good practice for the reprocessing of medical devices for Swiss health facilities" (GPA), version 2022

27.12.2021

FSN requirements for publication

Every recall and other FSCA reported to Swissmedic is published on the Swissmedic website, in the form and with the content provided by the manufacturer.

23.12.2021

Notification for mandate as Swiss authorised representative (CH-REP)

New form for notification for mandate as Swiss authorised representative.

30.11.2021

Medical devices: Swiss economic operators registered at Swissmedic

The overview shows all manufacturers, importers and authorised representatives domiciled in Switzerland registered at Swissmedic.

15.11.2021

Update of the information sheet Procurement of medical devices in health institutions

Additional information on the import of medical devices by healthcare professionals and health institutions

27.09.2021

Frequently Asked Questions on medical devices – FAQ MD

Updates to the frequently asked questions (FAQ) on medical devices

Updated PDF forms

MU680_21_019e_FO Field Safety Corrective Action (FSCA) Report (PDF, 2 MB, 13.01.2022)

MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 395 kB, 07.01.2022)

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 335 kB, 30.12.2021)

BW630_11_003e_FO Mandate registration form (PDF, 1 MB, 23.12.2021)

BW610_00_015e_MB Clinical trials of medical devices (PDF, 443 kB, 02.12.2021)

BW610_20_023e_FO Clinical trials of medical devices: Serious adverse events and device deficiencies in Switzerland (PDF, 1 MB, 01.12.2021)

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 19.01.2022

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