{"d":{"__metadata":{"id":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')","uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')","type":"itsystems.Pd.DataServices.DataModel.Business"},"BusinessResponsibilities":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/BusinessResponsibilities"}},"RelatedBusinesses":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/RelatedBusinesses"}},"BusinessRoles":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/BusinessRoles"}},"Publications":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Publications"}},"LegislativePeriods":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/LegislativePeriods"}},"Sessions":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Sessions"}},"Preconsultations":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Preconsultations"}},"Bills":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Bills"}},"Councils":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Councils"}},"BusinessTypes":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/BusinessTypes"}},"Votes":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Votes"}},"SubjectsBusiness":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/SubjectsBusiness"}},"BusinessStates":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/BusinessStates"}},"Council":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Council"}},"Transcripts":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20258087,Language='FR')/Transcripts"}},"ID":20258087,"Language":"FR","BusinessShortNumber":"25.8087","BusinessType":14,"BusinessTypeName":"Heure des questions. Question","BusinessTypeAbbreviation":"Qst.","Title":"Quels crit\u00e8res pour la proc\u00e9dure simplifi\u00e9e d'autorisation des dispositifs m\u00e9dicaux approuv\u00e9s par la FDA ?","Description":null,"InitialSituation":null,"Proceedings":null,"DraftText":null,"SubmittedText":"<p>Dans le cadre de la mise en \u0153uvre de la motion 20.3211 et dans la perspective d'une diversification des sources d'approvisionnement en dispositifs m\u00e9dicaux, le Conseil f\u00e9d\u00e9ral pr\u00e9voit-il d'\u00e9tablir un catalogue de crit\u00e8res fondamentaux qui d\u00e9finisse \u00e0 la fois les conditions de reconnaissance d'autres autorisations non europ\u00e9ennes en plus de celles de la FDA et les exigences sp\u00e9cifiques en mati\u00e8re d'agr\u00e9ment et de comp\u00e9tence des organismes de contr\u00f4le priv\u00e9s \u00e0 mandater en Suisse?</p>","ReasonText":null,"DocumentationText":null,"MotionText":null,"FederalCouncilResponseText":"<span><p><span>Le Conseil f\u00e9d\u00e9ral a d\u00e9fini en avril 2025 les lignes directrices de mise en \u0153uvre de la motion M\u00fcller (20.3211). En accord avec le secteur des technologies m\u00e9dicales, celles-ci se concentrent actuellement uniquement sur la r\u00e9glementation des conditions g\u00e9n\u00e9rales pour la mise sur le march\u00e9 des dispositifs m\u00e9dicaux commercialis\u00e9s aux \u00c9tats-Unis. Il n'est toutefois pas exclu que d'autres syst\u00e8mes r\u00e9glementaires soient ajout\u00e9s ult\u00e9rieurement. </span></p><p><span>&nbsp;</span></p><p><span>Au vu des diff\u00e9rences entre les r\u00e9glementations suisses et \u00e9tatsuniennes, le Conseil f\u00e9d\u00e9ral a d\u00e9cid\u00e9 que des exigences sp\u00e9cifiques devront s\u2019appliquer pour la mise sur le march\u00e9 suisse de ces dispositifs. Cela pourra notamment inclure la fourniture de preuves cliniques pour d\u00e9montrer la performance des dispositifs lorsque la </span><em><span>Food and Drug Administration</span></em><span> (FDA) ne les exige pas, des \u00e9l\u00e9ments relatifs au syst\u00e8me de gestion de la qualit\u00e9, ainsi que des mesures de surveillance du march\u00e9. Comme dans la r\u00e9glementation actuelle, des organismes priv\u00e9s seront charg\u00e9s de v\u00e9rifier ces points dans le cadre d\u2019une proc\u00e9dure simplifi\u00e9e d\u2019\u00e9valuation de la conformit\u00e9. Des crit\u00e8res sp\u00e9cifiques devront \u00e9galement \u00eatre d\u00e9finis pour encadrer l\u2019activit\u00e9 de ces organismes. </span></p></span>","FederalCouncilProposal":null,"FederalCouncilProposalText":null,"FederalCouncilProposalDate":"\/Date(1765152000000)\/","SubmittedBy":"Piller Carrard Val\u00e9rie","BusinessStatus":229,"BusinessStatusText":"Liquid\u00e9","BusinessStatusDate":"\/Date(1765211989000)\/","ResponsibleDepartment":4,"ResponsibleDepartmentName":"D\u00e9partement de l'int\u00e9rieur","ResponsibleDepartmentAbbreviation":"DFI","IsLeadingDepartment":true,"Tags":"15|2841","Category":null,"Modified":"\/Date(1765212000497)\/","SubmissionDate":"\/Date(1764720000000)\/","SubmissionCouncil":1,"SubmissionCouncilName":"Conseil national","SubmissionCouncilAbbreviation":"CN","SubmissionSession":5211,"SubmissionLegislativePeriod":52,"FirstCouncil1":1,"FirstCouncil1Name":"Conseil national","FirstCouncil1Abbreviation":"CN","FirstCouncil2":null,"FirstCouncil2Name":null,"FirstCouncil2Abbreviation":null,"TagNames":"\u00c9conomie|Sant\u00e9"}}