DECRETO 10 agosto 2018 - Documento d'indirizzo per la stesura di capitolati di gara per l'acquisizione di dispositivi medici. (18A06933)
IL MINISTRO DELLA SALUTE Visto il decreto del Ministro della salute 20 febbraio 2007, recante «Nuove modalita' per gli adempimenti previsti dall'art. 13 del decreto legislativo 24 febbraio 1997, n. 46 e successive modificazioni e per la registrazione dei dispositivi impiantabili attivi nonche' per nel repertorio dei dispositivi medici»;
Visto il decreto del Ministro della salute del 21 dicembre 2009, recante modifiche ed integrazioni al decreto 20 febbraio 2007, recante «Nuove modalita' per gli adempimenti previsti per la registrazione dei dispositivi impiantabili attivi nonche' per l'iscrizione nel repertorio dei dispositivi medici»;
Visto il decreto del Ministro della salute delL'11 giugno 2010, recante «Istituzione del flusso informativo per il monitoraggio dei consumi dei dispositivi medici direttamente acquistati dal Servizio sanitario nazionale»;
Visti il decreto-legge 24 aprile 2014, n. 66 «Misure urgenti per la competitivita' e la giustizia sociale», convertito, con modificazioni, dalla legge 23 giugno 2014, n. 89;
Vista l'intesa del 10 luglio 2014 tra il Governo, le regioni e le Province autonome di Trento e Bolzano concernente il nuovo Patto per la salute per gli anni 2014-2016 (rep. atti n. 82/CSR) e, in particolare, l'art. 26, comma 3;
Visto il decreto del Presidente del Consiglio dei ministri 11 novembre 2014, recante «Requisiti per l'iscrizione nell'elenco dei soggetti aggregatori, ai sensi dell'art. 9, comma 2, secondo periodo, del decreto-legge 24 aprile 2014, n. 66, convertito, con modificazioni, dalla legge 23 giugno 2014, n. 89, insieme con il relativo elenco recante gli oneri informativi»;
Visto l'art. 1, comma 587, lettera b), della legge 23 dicembre 2014, n. 190 (legge di stabilita' 2015), il quale ha stabilito che il Ministro della salute avvalendosi dell'Agenzia nazionale per i servizi sanitari regionali (AGENAS) e dell'Agenzia italiana del farmaco (AIFA), per gli aspetti di relativa competenza, provvede a individuare, per la predisposizione dei capitolati di gara, i requisiti indispensabili per l'acquisizione dei dispositivi medici a livello nazionale, regionale, intra-regionale o aziendale, e indicare gli elementi per la...
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