Swissmedic Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Swissmedic (Swiss Agency for Therapeutic Products)
Key Legislation:
- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA/HMG)
- Medical Devices Ordinance (MedDO) -- effective 26 May 2021, aligned with EU MDR 2017/745
- Ordinance on In Vitro Diagnostic Medical Devices (IvDO) -- effective 26 May 2022, aligned with EU IVDR 2017/746
Classification: Risk-based, 4 classes (I, IIa, IIb, III) -- mirroring the EU MDR classification system.
Registration Pathway:
- Conformity assessment under EU MDR with an EU Notified Body (CE marking required)
- Appoint a Swiss Authorised Representative (CH-REP) for foreign manufacturers
- Register as economic operator in swissdamed to obtain CHRN (Swiss Registration Number)
- Register devices in swissdamed UDI Devices module (mandatory from 1 July 2026)
Key Requirements:
- CE marking under EU MDR/IVDR is required for Swiss market access
- CH-REP is mandatory for all non-Swiss manufacturers (EU AR does not satisfy this requirement)
- swissdamed device registration: mandatory from 1 July 2026, transition period until 31 December 2026
- No interface between swissdamed and EUDAMED -- separate registration required
Current Key Guidance:
- swissdamed Registration Guide
- CH-REP & Economic Operator Registration (CHRN)
- FSCA Reporting (Vigilance)
Latest Updates
BLEPHADEMODEX Sterile Skin-Cleaning Wipe: Swissmedic FSCA by Laboratoires Théa
2026-07-10 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for BLEPHADEMODEX, a sterile skin-cleaning wipe manufactured by Laboratoires Théa. The reason for the corrective action has not been specified in the notice. Affected model and lot numbers are not detailed; however, users should immediately quarantine the product and follow the manufacturer's instructions for return or disposal. This action underscores the importance of sterility assurance in medical devices.
Tags: fsca, swissmedic, sterile_wipe, medical_device, recall, laboratoires_thea, blephademodex
Swissmedic FSCA: Getinge Disinfection AB Warming Cabinets Model 363 – General-Purpose Drying Cabinet
2026-07-09 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Getinge Disinfection AB's general-purpose drying cabinet, marketed as warming cabinets, model 363. The specific reason for the corrective action is not detailed in the notice, but the manufacturer is taking necessary measures to address a potential safety or performance issue. Affected users should follow the manufacturer's instructions provided through the FSCA and contact Getinge Disinfection AB for further guidance.
Tags: swissmedic, fsca, warming_cabinet
Swissmedic FSCA: Comecer IRIS Infusion Pump – Added German Language Version (Model 0246010026)
2026-07-08 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for Comecer Netherlands B.V.'s IRIS infusion pump, model number 0246010026. The action was taken to provide a German language version of the device documentation, addressing the risk of use errors among German-speaking users. Affected units should be updated with the new German documents following the manufacturer's instructions.
Tags: swissmedic, fsca, infusion_pump, comecer, german_language, product_correction
Swissmedic Issues FSCA for Philips Allura Stationary Angiographic X-Ray Systems
2026-07-08 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Philips Allura stationary angiographic X-ray systems manufactured by Philips Medical Systems Nederland B.V. The affected models are 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. Although the specific reason for the corrective action was not detailed in the notice, users are required to contact Philips immediately for instructions to ensure safe operation.
Tags: swissmedic, fsca, philips_allura, angiographic_x_ray, medical_device_recall
Swissmedic FSCA: BAL Flush Syringe SS, 10 ml by Jiaxing Tianhe Pharmaceutical
2026-07-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the BAL Flush Syringe SS, 10 ml (model BAL 464013) manufactured by Jiaxing Tianhe Pharmaceutical Co., Ltd. The specific reason for the corrective action has not been disclosed, but it concerns the pre-filled syringes. Healthcare facilities should identify affected products, quarantine them, and follow the manufacturer's instructions for return or disposal.
Tags: swissmedic, fsca, medical_device, prefilled_syringe, recall
Swissmedic FSCA: Boston Scientific Rapid Refill Continuous Injection System Cholangiography Tubing Set
2026-07-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Boston Scientific Rapid Refill Continuous Injection System, specifically the Cholangiography tubing set (GTIN 08714729285151, UPN M00566001). The reason for the corrective action is detailed in the manufacturer's notification. Healthcare facilities should identify affected devices, quarantine them, and follow Boston Scientific’s instructions to mitigate any safety risks.
Tags: swissmedic, fsca, boston_scientific, cholangiography_tubing, medical_device, safety_corrective_action, switzerland
Swissmedic FSCA: Automated Impella Controller by Abiomed – Models 0042-0040, 0042-0010, 0042-0000 and variants
2026-07-06 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a field safety corrective action (FSCA) for the Automated Impella Controller (AIC) manufactured by Abiomed Inc. The affected devices are intracardiac circulatory assist axial-pump catheter control units with model numbers 0042-0040, 0042-0010, 0042-0000, and their EU/UK variants. While the specific reason is not detailed in the notice, users should consult the manufacturer’s instructions for the required corrective actions to ensure patient safety.
Tags: swissmedic, fsca, impella, heart_pump, abiomed, safety_alert, cardiac_assist
FSCA: B. Braun Infusomat Space P Single-Channel Infusion Pump (Model 8713070)
2026-07-02 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the B. Braun Melsungen AG Infusomat Space P bedside infusion pump, model 8713070. The reason for the corrective action is not detailed in the brief notice, but it signals a potential safety issue requiring user attention. Healthcare facilities using this device should immediately consult the full FSCA on the Swissmedic portal and follow the manufacturer's recommended actions to mitigate any risk.
Tags: swissmedic, fsca, infusion_pump, safety, b_braun, field_safety_corrective_action
Swissmedic FSCA: Olympus Single Use Distal Cover (MAJ-2315) Patient Protection Cap
2026-07-01 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Olympus Single Use Distal Cover, a single-use endoscope patient protection cap. The affected model is MAJ-2315 and lot N6192000. While the specific reason for the corrective action was not detailed in the notification, users should immediately identify and quarantine affected products and follow Olympus' instructions to mitigate potential risks.
Tags: swissmedic, fsca, olympus, distal_cover
Swissmedic FSCA for SY-LAB IceCube Linear Rate Medical Freezers
2026-07-01 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for SY-LAB IceCube medical freezers with linear rate control, affecting models 11XS MED, 14S MED, 14M MED, 17M MED, 17L MED and their non-MED variants. The specific safety reason was not published in the initial notice. Users in laboratories and healthcare settings should immediately review the full FSCA on the Swissmedic portal and follow the manufacturer's corrective measures.
Tags: swissmedic, fsca, medical_freezer, laboratory_equipment, safety_correction
FSCA for Medline MEDSTOP Stopcock: New Language Added to Labeling
2026-06-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a field safety corrective action for the MEDSTOP stopcock manufactured by Medline Industries LP. The corrective action involves adding a new language to the device labeling to meet regulatory requirements. Affected models are identified by their Field Safety Notice (FSN). Distributors and healthcare facilities should ensure the updated labeling is used.
Tags: stopcock, labeling_update, field_safety_corrective_action, medline, swissmedic
FARADRIVE Steerable Sheath: Swissmedic FSCA for Added Language to Labeling
2026-06-16 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for Boston Scientific's FARADRIVE Steerable Sheath, a single-use vascular guide-catheter. The reason is the addition of a new language to the product labeling, categorized as a correction. Affected models are referenced in the FSN; users should update and follow the revised instructions for use.
Tags: swissmedic, fsca, labeling_update, steerable_sheath, boston_scientific
Swissmedic FSCA: Armstrong Medical PEP Therapy APL Valve – Language Addition to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic Field Safety Corrective Action (FSCA) concerns the APL Valve used in Positive Expiratory Pressure (PEP) Therapy Devices from Armstrong Medical Limited. The reason for the correction is the addition of a new language to the device labeling, likely to meet local regulatory language requirements. Affected models are listed in the Field Safety Notice (FSN). No direct patient safety issue is involved; users should follow the updated labeling instructions.
Tags: swissmedic, fsca, medical_device, labeling_update, pep_therapy, armstrong_medical, apl_valve
Swissmedic FSCA: Armstrong Medical Adult Coaxial Breathing Systems APL Valve - Added Language to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA addresses Armstrong Medical Limited's Adult Coaxial Breathing Systems, specifically the APL valve. The corrective action adds a new language to the device labeling or instructions for use, ensuring compliance with Swiss official language requirements. Affected models are detailed in the related Field Safety Notice (FSN). Users should verify they have the updated labeling and follow the manufacturer's instructions.
Tags: swissmedic, fsca, breathing_system, armstrong_medical, labeling_update, apl_valve, language
Swissmedic FSCA: Armstrong Medical Resuscitation Sets (Mapleson Systems) – APL Valve Labeling Language Update
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses Armstrong Medical Limited's Resuscitation Sets (Mapleson Systems) where the APL valve labeling required a new language addition. Affected models are listed in the Field Safety Notice (FSN). Users are advised to consult the FSN and ensure the updated labeling is integrated into the instructions for use. This is a documentation correction, not a safety defect.
Tags: swissmedic, fsca, labeling_correction, resuscitation_set, armstrong_medical
Swissmedic FSCA: Paediatric Ayres T‑Piece Systems – APL Valve Label Updated with New Language
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Armstrong Medical Limited's Paediatric Ayres T‑Piece Systems (Resuscitation Set) affecting the APL Valve. The corrective action involves adding a new language to the device labelling to ensure proper use. Affected models are detailed in the Field Safety Notice (FSN); users should review the updated instructions and share the notice with relevant personnel.
Tags: swissmedic, fsca, medical_device, labeling_correction, pediatric_resuscitation, apl_valve
Swissmedic Expands °M Warmer FSCA: 7 More Lots Affected for MEQU A/S Blood/Fluid Warmer
2026-05-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated the Field Safety Corrective Action (FSCA) for MEQU A/S's °M Warmer, a conduction blood/fluid warmer, expanding the affected scope to include 7 additional lots. The correction applies to models MWS201 (Box of 5) and MWS201W (Single in Silver Pouch). Users should identify impacted devices and follow the manufacturer's instructions provided in the original FSCA notice.
Tags: swissmedic, fsca, blood_fluid_warmer, mequ, lot_expansion
Swissmedic FSCA: Staar Surgical AG IOD Software – New Information for Ophthalmology Instruments
2026-04-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for IOD Software, a software accessory manufactured by Staar Surgical AG used with various ophthalmology instruments. The corrective action stems from new information about the software, though affected model or lot details are not specified. Users of the impacted software should follow recommended actions such as applying updates or contacting the manufacturer to maintain safe and effective operation.
Tags: swissmedic, fsca, ophthalmology, software
Swissmedic FSCA: Sphere-9 Catheter – Updated Field Safety Notice (Medtronic/BIOTRONIK)
2026-03-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Sphere-9 Catheter (Model AFR-00001), manufactured by Medtronic, Inc. and BIOTRONIK SE & Co. KG. The reason is a new version of the Field Safety Notice (FSN) for this cardiac tissue ablation device. Affected users should review the updated FSN and implement any revised instructions.
Tags: fsca, cardiac_ablation_catheter, field_safety_notice
Follow-up Field Safety Notice for ORBIS Medication 3.x by DH Healthcare GmbH
2026-01-23 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a follow-up Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. This notice provides additional information supplementing previously issued Field Safety Notices (FSNs). Affected model numbers are not specified in the notice. Users should review the updated safety information and follow the manufacturer’s recommendations.
Tags: swissmedic, fsca, field_safety_notice, follow_up, medical_device_software, dh_healthcare, orbis_medication
Zimmer Tourniquet Systems: Field Safety Corrective Action for Serial Number Update (Models 60500010100, 60320010100)
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Zimmer Surgical, Inc. has issued a Field Safety Corrective Action (FSCA) for the Zimmer Tourniquet Systems concerning models 60500010100 and 60320010100. The reason is to update serial numbers, which may involve correcting records or labeling to maintain traceability. Affected users should follow the manufacturer’s instructions to verify and update the serial numbers as required.
Tags: swissmedic, fsca, tourniquet_system, serial_number_update, zimmer_surgical
Zimmer Tourniquet Systems Serial Number Update – Swissmedic FSCA
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Zimmer Surgical's pneumatic tourniquet systems (models 60500010100, 60320010100). The corrective action is to update serial numbers, likely due to labeling or documentation discrepancies. Affected users should follow manufacturer instructions to verify and update the serial numbers; no product recall or return is required.
Tags: swissmedic, fsca, zimmer_surgical, tourniquet_system, serial_number_update