{"id":769,"date":"2024-01-17T16:52:10","date_gmt":"2024-01-17T08:52:10","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=769"},"modified":"2024-01-17T16:52:10","modified_gmt":"2024-01-17T08:52:10","slug":"medical-term-list","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/it\/medical-term-list\/","title":{"rendered":"Elenco dei termini medici"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Cinese<\/span><\/td>\nInglese<\/span><\/td>\n<\/tr>\n
\u4ea7\u54c1\u6280\u672f\u8d44\u6599<\/span><\/td>\nMateriale tecnico del prodotto<\/span><\/td>\n<\/tr>\n
\u68c0\u9a8c\u4e2d\u5fc3<\/span><\/td>\nCentro di test<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u68c0\u9a8c<\/span><\/td>\nTest di registrazione<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5355\u5143<\/span><\/td>\nUnit\u00e0 registrata<\/span><\/td>\n<\/tr>\n
\u9884\u8bc4\u4ef7\u610f\u89c1<\/span><\/td>\nPareri di pre-valutazione<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0<\/span><\/td>\nDispositivo medico predicato<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784<\/span><\/td>\nIstituti di sperimentazione clinica<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a<\/span><\/td>\nComitato etico<\/span><\/td>\n<\/tr>\n
\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nSperimentazioni cliniche multicentriche<\/span><\/td>\n<\/tr>\n
\u5f62\u5f0f\u5ba1\u67e5<\/span><\/td>\nEsame formale<\/span><\/td>\n<\/tr>\n
\u8ba4\u8bc1\u8bc1\u4e66<\/span><\/td>\nAutorit\u00e0 di certificazione, CA<\/span><\/td>\n<\/tr>\n
\u53d7\u7406\u901a\u77e5\u5355<\/span><\/td>\nAvviso di accettazione<\/span><\/td>\n<\/tr>\n
\u7f34\u8d39\u901a\u77e5\u4e66<\/span><\/td>\nPolizza di pagamento<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66<\/span><\/td>\nLettera di carenza<\/span><\/td>\n<\/tr>\n
\u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66<\/span><\/td>\nAvviso di rifiuto<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u8981\u6c42<\/span><\/td>\nRequisiti del supplemento<\/span><\/td>\n<\/tr>\n
\u53d1\u8865\u540e\u54a8\u8be2<\/span><\/td>\nConsultazione dopo il Supplemento<\/span><\/td>\n<\/tr>\n
\u73b0\u573a\u54a8\u8be2<\/span><\/td>\nConsultazione in loco<\/span><\/td>\n<\/tr>\n
\u7f51\u4e0a\u54a8\u8be2<\/span><\/td>\nConsultazione online<\/span><\/td>\n<\/tr>\n
\u8865\u6b63\u8d44\u6599\u9884\u5ba1\u67e5<\/span><\/td>\nPre-valutazione per i documenti integrativi<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a<\/span><\/td>\nRiunione di consultazione degli esperti<\/span><\/td>\n<\/tr>\n
\u8bb8\u53ef\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nModifiche delle voci di autorizzazione<\/span><\/td>\n<\/tr>\n
\u767b\u8bb0\u4e8b\u9879\u53d8\u66f4<\/span><\/td>\nModifiche delle voci del Registro di sistema<\/span><\/td>\n<\/tr>\n
\u8bf4\u660e\u4e66\u66f4\u6539\u544a\u77e5<\/span><\/td>\nNotifica sulle modifiche alle istruzioni per l'uso<\/span><\/td>\n<\/tr>\n
\u5730\u533a\u6027\u7ba1\u7406\u4fe1\u606f<\/span><\/td>\nAmministrativo regionale<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599\u76ee\u5f55<\/span><\/td>\nIndice della presentazione<\/span><\/td>\n<\/tr>\n
\u672f\u8bed\u7f29\u5199\u8bcd\u5217\u8868<\/span><\/td>\nElenco dei termini\/acronimi<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u5217\u8868<\/span><\/td>\nElenco dei dispositivi<\/span><\/td>\n<\/tr>\n
\u7b26\u5408\u6027\u9648\u8ff0\u8ba4\u8bc1\u58f0\u660e<\/span><\/td>\nDichiarazioni\/Certificazioni\/Dichiarazioni di conformit\u00e0<\/span><\/td>\n<\/tr>\n
\u5668\u68b0\u63cf\u8ff0<\/span><\/td>\nDescrizione del dispositivo<\/span><\/td>\n<\/tr>\n
\u9002\u7528\u8303\u56f4\u548c\u6216\u9884\u671f\u7528\u9014\u53ca\u7981\u5fcc\u75c7<\/span><\/td>\nIndicazioni per l'uso e\/o uso previsto e controindicazioni<\/span><\/td>\n<\/tr>\n
\u5168\u7403\u4e0a\u5e02\u5386\u7a0b<\/span><\/td>\nStoria del mercato globale<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6709\u6548\u57fa\u672c\u8981\u6c42(EP)\u6e05\u5355<\/span><\/td>\nLista di controllo dei Principi Essenziali (PE)<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u8d44\u6599<\/span><\/td>\nProve non cliniche<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76<\/span><\/td>\nStudi non clinici<\/span><\/td>\n<\/tr>\n
\u975e\u4e34\u5e8a\u7814\u7a76\u6587\u732e<\/span><\/td>\nBibliografia non clinica<\/span><\/td>\n<\/tr>\n
\u8d27\u67b6\u5bff\u547d\u548c\u5305\u88c5\u9a8c\u8bc1<\/span><\/td>\nPeriodo di scadenza e convalida del pacchetto<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bc1\u636e\u7efc\u8ff0<\/span><\/td>\nRiassunto complessivo delle evidenze cliniche<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\u7684\u76f8\u5173\u6587\u4ef6<\/span><\/td>\nModuli di consenso informato approvati dall'IRB<\/span><\/td>\n<\/tr>\n
\u76d1\u7ba1\u4fe1\u606f<\/span><\/td>\nInformazioni normative<\/span><\/td>\n<\/tr>\n
\u4ee3\u7406\u4eba<\/span><\/td>\nAgente<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u4ee3\u7406\u4eba<\/span><\/td>\nAgente registrato<\/span><\/td>\n<\/tr>\n
\u5883\u5185\u7533\u8bf7\u4eba<\/span><\/td>\nImprese manifatturiere nazionali<\/span><\/td>\n<\/tr>\n
\u5883\u5916\u7533\u8bf7\u4eba<\/span><\/td>\nImprese manifatturiere d'oltremare<\/span><\/td>\n<\/tr>\n
\u5f53\u5730\u7701\u5c40<\/span><\/td>\nUfficio provinciale locale<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3\u54a8\u8be2\u767b\u8bb0\u8868<\/span><\/td>\nModulo di registrazione per la consultazione presso il CMDE<\/span><\/td>\n<\/tr>\n
\u533b97\u21a9\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u7814\u7a76\u6240<\/span><\/td>\nCentro per la supervisione standardizzata<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u8d44\u8d28<\/span><\/td>\nQualificazione dei test sui dispositivi medici<\/span><\/td>\n<\/tr>\n
\u68c0\u6d4b\u4e2d\u5fc3\u627f\u68c0\u76ee\u5f55\u5e93<\/span><\/td>\nElenco dei centri d'esame<\/span><\/td>\n<\/tr>\n
\u9700\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u6279\u7684\u7b2c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u76ee\u5f55<\/span><\/td>\nCatalogo dei dispositivi medici di classe III che richiedono l'approvazione di sperimentazioni cliniche<\/span><\/td>\n<\/tr>\n
\u540c\u54c1\u79cd\u6bd4\u5bf9<\/span><\/td>\nConfronto con il dispositivo medico di riferimento\u00a0<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u7b49\u540c<\/span><\/td>\nEquivalente sostanziale (SE)<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u4ea7\u54c1<\/span><\/td>\nOggetto Prodotto<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848<\/span><\/td>\nProtocollo di sperimentazione clinica<\/span><\/td>\n<\/tr>\n
\u5c0f\u6837\u672c\u53ef\u884c\u6027\u7814\u7a76<\/span><\/td>\nStudio di fattibilit\u00e0 su piccolo campione<\/span><\/td>\n<\/tr>\n
\u4f26\u7406\u59d4\u5458\u4f1a\u610f\u89c1<\/span><\/td>\nPareri del Comitato etico<\/span><\/td>\n<\/tr>\n
\u5b89\u5168\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nMetodo di valutazione della sicurezza<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/td>\nMetodo di valutazione dell'efficacia<\/span><\/td>\n<\/tr>\n
\u4e13\u5bb6\u54a8\u8be2\u4f1a\u8bae<\/span><\/td>\nRiunione di consultazione degli esperti<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u53f8<\/span><\/td>\nDipartimento per la regolamentazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u54c1\u8f36\u54c1\u68c0\u5b9a\u7814\u7a76\u9662<\/span><\/td>\nIstituti nazionali per il controllo degli alimenti e dei farmaci<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a<\/span><\/td>\nCommissione della Farmacopea cinese<\/span><\/td>\n<\/tr>\n
\u4e2d\u56fd\u54c1\u8f36\u54c1\u56fd\u9645\u4ea4\u6d41\u4e2d\u5fc3<\/span><\/td>\nCentro cinese per lo scambio internazionale di alimenti e farmaci<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178<\/span><\/td>\nFarmacopea della Repubblica Popolare Cinese<\/span><\/td>\n<\/tr>\n
\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u6807\u51c6\u5316\u6cd5<\/span><\/td>\nLegge sulla standardizzazione della Repubblica Popolare Cinese<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nle misure amministrative per l'ispezione a campione della qualit\u00e0 dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u91cd\u70b9\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nle misure amministrative per i laboratori chiave dell'NMPA<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u51fa\u53e3\u9500\u552e\u8bc1\u660e<\/span><\/td>\nLicenza di esportazione e vendita di dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8bb8\u53ef\u8bc1<\/span><\/td>\nCertificato di produzione per dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u5907\u6848\u51ed\u8bc1<\/span><\/td>\nCertificato di deposito di fabbricazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u5185\u90e8\u6838\u67e5<\/span><\/td>\nVerifica interna<\/span><\/td>\n<\/tr>\n
\u7f51\u7edc\u6838\u9a8c<\/span><\/td>\nVerifica online<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42\u548c\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u683c\u5f0f\u7684\u516c\u544a<\/span><\/td>\nAvviso sui requisiti dei fascicoli di domanda di registrazione dei dispositivi medici e sul formato dei documenti di approvazione<\/span><\/td>\n<\/tr>\n
\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42\u548c\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u683c\u5f0f\u7684\u516c\u544a<\/span><\/td>\nAvviso sui requisiti dei dossier di registrazione dei reagenti diagnostici in vitro e sul formato dei documenti di approvazione<\/span><\/td>\n<\/tr>\n
\u533b75\u21a9\u5668\u68b0\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6<\/span><\/td>\nStandard industriali obbligatori per i dispositivi medici<\/span><\/td>\n<\/tr>\n
\u5f3a\u5236\u6027\u884c\u4e1a\u6807\u51c6\u4f53\u7cfb<\/span><\/td>\nSistema di standard industriali obbligatori<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u671f\u9669\u8bc4\u21aaLOHAN_4EF\u62a5\u544a<\/span><\/td>\nRapporti periodici di valutazione del rischio dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u72ec\u7acb\u8f6f\u4ef6\u73b0\u573a\u68c0\u67e5\u6307\u5bfc\u539f\u5219<\/span><\/td>\nGuida per l'ispezione in loco del software indipendente allegato alle Norme di Buona Fabbricazione per i Dispositivi Medici<\/span><\/td>\n<\/tr>\n
\u9ad8\u503c\u533b\u7528\u8017\u6750<\/span><\/td>\nMateriali di consumo medicali di alto valore<\/span><\/td>\n<\/tr>\n
\u96c6\u4e2d\u91c7\u8d2d<\/span><\/td>\nApprovvigionamento centralizzato<\/span><\/td>\n<\/tr>\n
\u65e0\u83cc\u548c\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u76d1\u7763\u68c0\u67e5<\/span><\/td>\nSupervisione e ispezione dei dispositivi medici sterili e impiantabili<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba<\/span><\/td>\nRegistranti di dispositivi medici<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u4fe1\u606f\u7cfb\u7edf<\/span><\/td>\nil Sistema nazionale di informazione sul monitoraggio degli eventi avversi ai dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b97\u21a9\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\u901a\u62a5<\/span><\/td>\nNotifica di informazioni sugli eventi avversi dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8b66\u6212\u5feb\u8baf<\/span><\/td>\nEspressioni di farmacovigilanza dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u53ef\u7591\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<\/span><\/td>\nSospetti eventi avversi da dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u62d3\u5c55\u6027\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nRegolamenti per la gestione delle sperimentazioni cliniche estese sui dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b97\u21a9\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u6570\u636e\u5e93<\/span><\/td>\nDatabase di identificazione univoca dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u901a\u7528\u540d\u79f0\u547d\u540d<\/span><\/td>\nNomenclatura dei nomi comuni dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/span><\/td>\nAmministrazione nazionale dei prodotti medici, NMPA<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4<\/span><\/td>\nCommissione nazionale per la salute NHC<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u4e2d\u5fc3<\/span><\/td>\nCentro di gestione degli standard dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3<\/span><\/td>\nCentro per la valutazione dei dispositivi medici, CMDE<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b<\/span><\/td>\nRegolamenti per la supervisione e l'amministrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposizioni per la registrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposizioni per la registrazione dei reagenti diagnostici in vitro<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\u7ba1\u7406\u89c4\u5b9a<\/span><\/td>\nDisposizioni per le istruzioni e le etichette dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6807\u51c6\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposizioni per gli standard dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5206\u7c7b\u89c4\u5219<\/span><\/td>\nRegole per la classificazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nBuona pratica clinica per i dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u751f\u4ea7\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/td>\nDispositivi medici GMP<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u548c\u518d\u8bc4\u4ef7\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nDisposizioni per il monitoraggio e la rivalutazione degli eventi avversi dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u8d28\u91cf\u62bd\u67e5\u68c0\u9a8c\u7ba1\u7406\u529e\u6cd5<\/span><\/td>\nMisure amministrative per l'ispezione a campione della qualit\u00e0 dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4eba\u5236\u5ea6<\/span><\/td>\nSistema di registrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u521b\u65b0\u533b\u7597\u5668\u68b0R\u522b\u5ba1\u67e5\u7a0b\u5e8f<\/span><\/td>\nProcedure speciali di revisione dei dispositivi medici innovativi<\/span><\/td>\n<\/tr>\n
\u533b97\u21a9\u5668\u68b0\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02<\/span><\/td>\nApprovazione condizionata per la commercializzazione di dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6ce8\u518c\u9879\u76ee\u7acb\u5377\u5ba1\u67e5<\/span><\/td>\nRevisione della registrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5\u4fe1\u606f\u5316\u7cfb\u7edf<\/span><\/td>\nsistema elettronico di presentazione dei prodotti regolamentati (eRPS)<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7535\u5b50\u7533\u62a5<\/span><\/td>\nApplicazione elettronica della registrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u9996\u6b21\u6ce8\u518c<\/span><\/td>\nRegistrazioni iniziali<\/span><\/td>\n<\/tr>\n
\u5ef6\u7eed\u6ce8\u518c<\/span><\/td>\nRinnovo della registrazione<\/span><\/td>\n<\/tr>\n
\u53d8\u66f4\u6ce8\u518c<\/span><\/td>\nModifiche alla registrazione<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u68c0\u6d4b\u673a\u6784<\/span><\/td>\nOrganizzazioni di ispezione e test dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u8bc4\u7533\u8bf7<\/span><\/td>\nRichiesta di esame e approvazione della sperimentazione clinica<\/span><\/td>\n<\/tr>\n
\u514d\u4e8e\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u533b\u7597\u5668\u68b0\u76ee\u5f55<\/span><\/td>\nCataloghi dei dispositivi medici esenti da sperimentazione clinica<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6838\u67e5<\/span><\/td>\nVerifica del sistema di gestione della qualit\u00e0 per la registrazione dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u751f\u4ea7\u73b0\u573a\u68c0\u67e5<\/span><\/td>\nIspezioni del sito di produzione<\/span><\/td>\n<\/tr>\n
\u533b\u7597\u5668\u68b0\u5b89\u5168\u548c\u6027\u80fd\u57fa\u672c\u539f406\u21a9<\/span><\/td>\nPrincipi fondamentali per la sicurezza e le prestazioni dei dispositivi medici<\/span><\/td>\n<\/tr>\n
\u7533\u62a5\u8d44\u6599<\/span><\/td>\nDossier di candidatura<\/span><\/td>\n<\/tr>\n
\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279<\/span><\/td>\nRevisione e approvazione della registrazione<\/span><\/td>\n<\/tr>\n
\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u5e74\u5ea6\u62a5\u544a<\/span><\/td>\nRelazione annuale per il monitoraggio nazionale degli eventi avversi ai dispositivi medici<\/span><\/td>\n<\/tr>\n
\u56fd\u4ea7\u5668\u68b0<\/span><\/td>\nDispositivo domestico<\/span><\/td>\n<\/tr>\n
\u8fdb\u53e3\u5668\u68b0<\/span><\/td>\nDispositivo importato<\/span><\/td>\n<\/tr>\n
\u5916\u6e90\u56e0\u5b50<\/span><\/td>\nAgenti avventizi<\/span><\/td>\n<\/tr>\n
\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nStudi controllati attivi<\/span><\/td>\n<\/tr>\n
\u7533\u8bf7\u4eba<\/span><\/td>\nRichiedente<\/span><\/td>\n<\/tr>\n
\u7b80\u8981\u603b\u7ed3<\/span><\/td>\nBreve sintesi<\/span><\/td>\n<\/tr>\n
\u83b7\u76ca\u4e0e\u98ce\u9669\u7ed3\u8bba<\/span><\/td>\nConclusioni su benefici e rischi<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u836f\u5242\u5b66\u7814\u7a76<\/span><\/td>\nStudi biofarmaceutici<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u5229\u7528\u5ea6<\/span><\/td>\nBiodisponibilit\u00e0<\/span><\/td>\n<\/tr>\n
\u751f\u7269\u7b49\u6548\u6027<\/span><\/td>\nBioequivalenza<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7efc\u8ff0<\/span><\/td>\nPanoramica clinica<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u603b\u7ed3<\/span><\/td>\nRiassunto clinico<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span><\/td>\nRapporti di studi clinici<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u6709\u6548\u6027<\/span><\/td>\nEfficacia clinica<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u5b89\u5168\u6027<\/span><\/td>\nSicurezza clinica<\/span><\/td>\n<\/tr>\n
\u4e34\u5e8a\u836f\u7406\u5b66<\/span><\/td>\nFarmacologia clinica<\/span><\/td>\n<\/tr>\n
\u63a7\u5236\u7b56\u7565<\/span><\/td>\nStrategia di controllo<\/span><\/td>\n<\/tr>\n
\u836f\u5178\u5404\u8bba<\/span><\/td>\nMonografie compendiali<\/span><\/td>\n<\/tr>\n
\u5173\u952e\u6b65\u9aa4<\/span><\/td>\nPassi critici<\/span><\/td>\n<\/tr>\n
\u836f\u5178<\/span><\/td>\nCompendiale<\/span><\/td>\n<\/tr>\n
\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/td>\nStudi clinici controllati<\/span><\/td>\n<\/tr>\n
\u7269\u6599\u63a7\u5236<\/span><\/td>\nControllo dei materiali<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u6280\u672f\u6587\u6863<\/span><\/td>\nDocumento tecnico comune<\/span><\/td>\n<\/tr>\n
\u6d53\u5ea6<\/span><\/td>\nConcentrazione<\/span><\/td>\n<\/tr>\n
\u5305\u88c5\u7cfb\u7edf<\/span><\/td>\nSistema di chiusura del contenitore<\/span><\/td>\n<\/tr>\n
\u5236\u5242<\/span><\/td>\nProdotto farmaceutico<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u9633\u6027\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nStudio in doppio cieco, controllato attivo<\/span><\/td>\n<\/tr>\n
\u539f\u6599\u836f\/\u539f\u6db2<\/span><\/td>\nSostanza stupefacente<\/span><\/td>\n<\/tr>\n
\u5242\u578b<\/span><\/td>\nForma di dosaggio<\/span><\/td>\n<\/tr>\n
\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c<\/span><\/td>\nStudio in doppio cieco, controllato con placebo<\/span><\/td>\n<\/tr>\n
\u8bbe\u5907<\/span><\/td>\nAttrezzatura<\/span><\/td>\n<\/tr>\n
\u8f85\u6599<\/span><\/td>\nEccipiente<\/span><\/td>\n<\/tr>\n
\u6709\u6548\u6027<\/span><\/td>\nEfficacia<\/span><\/td>\n<\/tr>\n
\u8bbe\u65bd<\/span><\/td>\nStruttura<\/span><\/td>\n<\/tr>\n
\u7ed3\u679c<\/span><\/td>\nRisultati<\/span><\/td>\n<\/tr>\n
\u6307\u5357<\/span><\/td>\nGuida<\/span><\/td>\n<\/tr>\n
\u7c92\u5ea6\u6587\u4ef6<\/span><\/td>\nDocumento di granularit\u00e0<\/span><\/td>\n<\/tr>\n
\u57fa\u672c\u4fe1\u606f<\/span><\/td>\nInformazioni generali<\/span><\/td>\n<\/tr>\n
\u901a\u7528\u672f\u8bed\u8868<\/span><\/td>\nGlossario generale dei termini<\/span><\/td>\n<\/tr>\n
\u4e00\u822c\u539f\u5219<\/span><\/td>\nPrincipi generali<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>","protected":false},"excerpt":{"rendered":"

Chinese English \u4ea7\u54c1\u6280\u672f\u8d44\u6599 Product Technical Materials \u68c0\u9a8c\u4e2d\u5fc3 Testing Center \u6ce8\u518c\u68c0\u9a8c Registration Test \u6ce8\u518c\u5355\u5143 Registered Unit \u9884\u8bc4\u4ef7\u610f\u89c1 Pre-evaluation Opinions \u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0 Predicate Medical Device \u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784 Clinical Trial\u00a0Institutes \u4f26\u7406\u59d4\u5458\u4f1a Ethics Committee \u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c Multi-center Clinical Trials \u5f62\u5f0f\u5ba1\u67e5 Formal Examination \u8ba4\u8bc1\u8bc1\u4e66 Certificate Authority, CA \u53d7\u7406\u901a\u77e5\u5355 Notice of Acceptance \u7f34\u8d39\u901a\u77e5\u4e66 Bill of Payment \u8865\u6b63\u8d44\u6599\u901a\u77e5\u4e66 Deficiency Letter \u4e0d\u4e88\u53d7\u7406\u901a\u77e5\u4e66 Notice of Rejection \u53d1\u8865\u8981\u6c42 […]<\/p>","protected":false},"author":4,"featured_media":770,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70],"tags":[201,202],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/posts\/769"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/comments?post=769"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/posts\/769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/media\/770"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/media?parent=769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/categories?post=769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/it\/wp-json\/wp\/v2\/tags?post=769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}