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July 2026

15.07.2026

MU102_10_001e_MB Notification of Quality Defects (PDF, 309 kB, 01.07.2026)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 588 kB, 10.07.2026)

13.07.2026

BW630_40_001e_MB Medical device registration fee (PDF, 222 kB, 13.07.2026)

09.07.2026

BW302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product) (XLSX, 55 kB, 01.07.2026)

08.07.2026

BW600_00_016e_MB Performance studies with IVD (PDF, 576 kB, 08.07.2026)

07.07.2026

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 2 MB, 07.07.2026)

01.07.2026

BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 01.07.2026)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 01.07.2026)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 01.07.2026)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.07.2026)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.07.2026)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 01.07.2026)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2026)

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 01.07.2026)

BW610_10_027e_FO Application combined study MP / ATMP and IVD (PDF, 1 MB, 01.07.2026)

BW610_10_026e_FO Application combined study MP / ATMP and MD (PDF, 1 MB, 01.07.2026)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 01.07.2026)

BW610_10_024e_FO Application performance study IVD (PDF, 1 MB, 01.07.2026)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 01.07.2026)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 01.07.2026)

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 01.07.2026)

OS000_00_029e_MB Instructions on User Management for Swissmedic Portal Roles in the eIAM Portal (PDF, 352 kB, 01.07.2026)

ZL000_00_029e_WL Guidance document Packaging texts for veterinary medicinal products (PDF, 356 kB, 01.07.2026)

BW600_00_016e_MB Performance studies with IVD (PDF, 576 kB, 08.07.2026)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 588 kB, 10.07.2026)

ZL300_00_004e_FO Variations TAM (DOCX, 693 kB, 01.07.2026)

ZL101_00_017e_WL Guidance document Simplified information requirements on the form for manufacturer information for the reduced dossier (PDF, 274 kB, 01.07.2026)

ZL000_00_049d_VL Patienteninformation für Humanarzneimittel (DOCX, 55 kB, 01.07.2026)Available in German, French or Italian only.

ZL000_00_048e_VL Product information for human medicinal products (DOCX, 58 kB, 01.07.2026)

ZL000_00_047d_VL Patienteninformation für Phytoarzneimittel HMV4 (DOCX, 74 kB, 01.07.2026)Available in German, French or Italian only.

ZL000_00_046d_VL Patienteninformation für Komplementärarzneimittel (DOCX, 76 kB, 01.07.2026)Available in German, French or Italian only.

OS000_00_003e_MB Archive access (PDF, 244 kB, 01.07.2026)

MU102_20_001d_MB Out-of-Stock Situation (PDF, 280 kB, 01.07.2026)

BW630_30_010e_MB FAQ on in vitro diagnostic medical device notifications (PDF, 293 kB, 01.07.2026)

BW630_30_009e_MB FAQ Notifications (PDF, 283 kB, 01.07.2026)

BW630_30_008e_MB Notifications devitalised human tissue (PDF, 253 kB, 01.07.2026)

BW617_00_003e_MB Derogation MEP (PDF, 264 kB, 01.07.2026)

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