{"d":{"__metadata":{"id":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')","uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')","type":"itsystems.Pd.DataServices.DataModel.Business"},"BusinessResponsibilities":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/BusinessResponsibilities"}},"RelatedBusinesses":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/RelatedBusinesses"}},"BusinessRoles":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/BusinessRoles"}},"Publications":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Publications"}},"LegislativePeriods":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/LegislativePeriods"}},"Sessions":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Sessions"}},"Preconsultations":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Preconsultations"}},"Bills":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Bills"}},"Councils":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Councils"}},"BusinessTypes":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/BusinessTypes"}},"Votes":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Votes"}},"SubjectsBusiness":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/SubjectsBusiness"}},"BusinessStates":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/BusinessStates"}},"Council":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Council"}},"Transcripts":{"__deferred":{"uri":"https://ws.parlament.ch/OData.svc/Business(ID=20257163,Language='FR')/Transcripts"}},"ID":20257163,"Language":"FR","BusinessShortNumber":"25.7163","BusinessType":14,"BusinessTypeName":"Heure des questions. Question","BusinessTypeAbbreviation":"Qst.","Title":"Pour une reconnaissance FDA aux USA des dispositifs m\u00e9dicaux-th\u00e9rapeutiques dans de brefs d\u00e9lais. ","Description":null,"InitialSituation":null,"Proceedings":null,"DraftText":null,"SubmittedText":"<p>Le 28 novembre 2022, le Conseil national a transmis la motion 20.3211 au Conseil f\u00e9d\u00e9ral qui demande que les dispositifs m\u00e9dicaux soumis \u00e0 un r\u00e9gime normatif non europ\u00e9en puissent \u00eatre import\u00e9s en Suisse.&nbsp;<br>De nombreuses demandes sont dans l'attente d'une certification FDA aux USA, \u00e0 l'exemple des exosquelettes. Quel est le calendrier de mise en oeuvre de la motion ainsi que des modifications l\u00e9gislatives y relatives afin que ces dispositifs soient reconnus dans les plus brefs d\u00e9lais ?</p>","ReasonText":null,"DocumentationText":null,"MotionText":null,"FederalCouncilResponseText":"<span><p><span>L\u2019Office f\u00e9d\u00e9ral de la sant\u00e9 publique, en collaboration avec Swissmedic, le Secr\u00e9tariat d'\u00c9tat du D\u00e9partement f\u00e9d\u00e9ral des affaires \u00e9trang\u00e8res et le Secr\u00e9tariat d'\u00c9tat \u00e0 l'\u00e9conomie travaille \u00e0 une solution qui permette la commercialisation en Suisse des dispositifs m\u00e9dicaux certifi\u00e9s par la </span><span><em>Food and Drug Administration</em></span><span> aux \u00c9tats-Unis.</span></p><p><span>Afin de mettre en \u0153uvre cette motion tout en garantissant la s\u00e9curit\u00e9 des patients, une analyse comparative des r\u00e9glementations suisses et am\u00e9ricaines en mati\u00e8re de dispositifs m\u00e9dicaux a \u00e9t\u00e9 effectu\u00e9e. Cette analyse r\u00e9v\u00e8le des diff\u00e9rences significatives entre les syst\u00e8mes r\u00e9glementaires qui peuvent avoir une incidence sur la s\u00e9curit\u00e9 des patients. Pour cette raison, le groupe de travail au sein de l\u2019administration a \u00e9labor\u00e9 des mesures pour compenser ces diff\u00e9rences, ainsi que des variantes de mise en \u0153uvre qui seront soumises au Conseil f\u00e9d\u00e9ral pour d\u00e9cision d\u2019ici l\u2019\u00e9t\u00e9 2025. Le Conseil f\u00e9d\u00e9ral doit mettre en \u0153uvre cette motion en tenant compte \u00e9galement des obligations internationales de la Suisse. D\u00e8s que le Conseil f\u00e9d\u00e9ral aura pris une d\u00e9cision, celle-ci sera communiqu\u00e9e.</span></p></span>","FederalCouncilProposal":null,"FederalCouncilProposalText":null,"FederalCouncilProposalDate":"\/Date(1742169600000)\/","SubmittedBy":"Roduit Benjamin","BusinessStatus":229,"BusinessStatusText":"Liquid\u00e9","BusinessStatusDate":"\/Date(1742226344000)\/","ResponsibleDepartment":4,"ResponsibleDepartmentName":"D\u00e9partement de l'int\u00e9rieur","ResponsibleDepartmentAbbreviation":"DFI","IsLeadingDepartment":true,"Tags":"15|2841","Category":null,"Modified":"\/Date(1763090215757)\/","SubmissionDate":"\/Date(1741564800000)\/","SubmissionCouncil":1,"SubmissionCouncilName":"Conseil national","SubmissionCouncilAbbreviation":"CN","SubmissionSession":5207,"SubmissionLegislativePeriod":52,"FirstCouncil1":1,"FirstCouncil1Name":"Conseil national","FirstCouncil1Abbreviation":"CN","FirstCouncil2":null,"FirstCouncil2Name":null,"FirstCouncil2Abbreviation":null,"TagNames":"\u00c9conomie|Sant\u00e9"}}