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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

MU680_23_001e_FO Template Periodic Summary Report (PSR) (DOCX, 386 kB, 10.12.2024)(Reporting Template)

BW690_00_002e_WL Export Certificates (PDF, 841 kB, 09.12.2024)

IN640_00_001e_MB Information sheet Medical devices – content requirements for CAPA plan (PDF, 309 kB, 02.12.2024)

BW630_30_005e_FO Notification in acc. with art. 103 para. 2 MedDO in conjunction with art. 6 para. 3 oMedDO for DEVIT products (PDF, 1 MB, 01.12.2024)

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 29.11.2024)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 29.11.2024)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 29.11.2024)

BW610_10_024e_FO Application performance study IVD (PDF, 1 MB, 29.11.2024)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 29.11.2024)

BW610_10_026e_FO Authorisation combined study IMP and MD (PDF, 1 MB, 29.11.2024)

BW610_10_027e_FO Authorisation combined study IMP and IVD (PDF, 1 MB, 29.11.2024)

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 29.11.2024)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 29.11.2024)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 29.11.2024)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 29.11.2024)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 29.11.2024)

BW630_30_008e_MB Notifications devitalised human tissue (PDF, 315 kB, 12.11.2024)

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)

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)

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 13.12.2024

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