[{"data":1,"prerenderedAt":165},["ShallowReactive",2],{"content-ch-representation-en":3},{"id":4,"title":5,"body":6,"description":156,"extension":157,"meta":158,"navigation":160,"path":161,"seo":162,"stem":163,"__hash__":164},"content\u002Fch-representation\u002Fch-representation.en.md","Swiss Authorized Representative (CH-REP) Services",{"type":7,"value":8,"toc":139},"minimark",[9,14,18,21,24,27,31,36,46,50,58,62,70,74,82,86,94,98,106,110,118,122,130,132,136],[10,11,13],"h2",{"id":12},"accessing-the-swiss-market","Accessing the Swiss Market",[15,16,17],"p",{},"According to the Swiss Medical Devices Ordinance (MedDO, SR 812.213), non-Swiss manufacturers placing medical devices or in vitro diagnostics on the Swiss market must appoint a Swiss Authorized Representative (CH-REP).",[15,19,20],{},"The CH-REP acts as the official legal representative of the foreign manufacturer in Switzerland, ensuring compliance with Swissmedic requirements, serving as the primary point of contact with authorities, and managing product registration in Swissdamed, the national database for medical devices.",[15,22,23],{},"ALTRION, based in Ticino, operates as your local CH-REP, ensuring regulatory alignment, correct labeling in the required Swiss languages (German, French, Italian), and continuous support throughout the entire product life cycle.",[25,26],"hr",{},[10,28,30],{"id":29},"our-services","Our Services",[32,33,35],"h3",{"id":34},"ch-rep-appointment-registration","CH-REP Appointment & Registration",[37,38,39,43],"ul",{},[40,41,42],"li",{},"Formal CH-REP appointment",[40,44,45],{},"Registration in Swissdamed for all device classes (Class I, IIa, IIb, III, and IVD)",[32,47,49],{"id":48},"labeling-language-compliance","Labeling & Language Compliance",[37,51,52,55],{},[40,53,54],{},"Verification of labeling and Instructions for Use (IFU)",[40,56,57],{},"Compliance with MedDO and MedDO-IVD multilingual requirements",[32,59,61],{"id":60},"documentation-review","Documentation Review",[37,63,64,67],{},[40,65,66],{},"Review of Declaration of Conformity",[40,68,69],{},"Verification of technical documentation consistency with MDR\u002FIVDR evidence",[32,71,73],{"id":72},"regulatory-communication","Regulatory Communication",[37,75,76,79],{},[40,77,78],{},"Communication with Swissmedic on behalf of the manufacturer",[40,80,81],{},"Notifications, vigilance reporting, and market surveillance follow-up",[32,83,85],{"id":84},"post-market-activities","Post-Market Activities",[37,87,88,91],{},[40,89,90],{},"Management of Post-Market Surveillance (PMS)",[40,92,93],{},"Coordination of Field Safety Corrective Actions (FSCA)",[32,95,97],{"id":96},"documentation-management","Documentation Management",[37,99,100,103],{},[40,101,102],{},"Archiving and maintenance of regulatory documentation in Switzerland",[40,104,105],{},"Ensuring traceability and availability for Swissmedic inspections",[32,107,109],{"id":108},"lifecycle-support","Lifecycle Support",[37,111,112,115],{},[40,113,114],{},"Support for renewals, modifications, and Swissdamed updates",[40,116,117],{},"Management of Basic UDI-DI and manufacturer data changes",[32,119,121],{"id":120},"regulatory-intelligence-optional","Regulatory Intelligence (Optional)",[37,123,124,127],{},[40,125,126],{},"Updates on Swissmedic guidance",[40,128,129],{},"Monitoring of EU–Swiss regulatory alignment",[25,131],{},[10,133,135],{"id":134},"our-approach","Our Approach",[15,137,138],{},"We act as a reliable local partner in Switzerland, ensuring that manufacturers meet all regulatory obligations while maintaining full control over their products and compliance strategy.",{"title":140,"searchDepth":141,"depth":141,"links":142},"",2,[143,144,155],{"id":12,"depth":141,"text":13},{"id":29,"depth":141,"text":30,"children":145},[146,148,149,150,151,152,153,154],{"id":34,"depth":147,"text":35},3,{"id":48,"depth":147,"text":49},{"id":60,"depth":147,"text":61},{"id":72,"depth":147,"text":73},{"id":84,"depth":147,"text":85},{"id":96,"depth":147,"text":97},{"id":108,"depth":147,"text":109},{"id":120,"depth":147,"text":121},{"id":134,"depth":141,"text":135},"Full support for CH-REP appointment, Swissmedic compliance, and Swiss market access for medical devices and IVDs.","md",{"image":159},"\u002Fimages\u002Fch-rep.jpg",true,"\u002Fch-representation\u002Fch-representation.en",{"title":5,"description":156},"ch-representation\u002Fch-representation.en","NJT-PyR25L0eXrLMwLrOQ1eRJ8SQP5D7n9jvJHDx-Lg",1775573784294]