Kusukela kuKhongolose Kazwelonke we-CPC we-18, iKomidi eliPhakathi le-CPC noComrade Xi Jinping emnyombeni walo liphikelele ekubekeni impilo yabantu endaweni yamasu okuthuthuka, futhi lenze ukuvikelwa kwempilo yabantu kwaba umgomo obalulekile womzabalazo weQembu kubantu. , eseyibonise ngokugcwele imibono yentuthuko egxile kubantu. Ukubuyekezwa kwezobuchwepheshe kwemishini yezokwelapha kulandela eduze ukuvezwa okubalulekile kukaNobhala Jikelele u-Xi Jinping mayelana nokwakhiwa kweShayina enempilo kanye nomoya weziyalezo ezibalulekile zokuqondisa izidakamizwa, ukunamathela ekugxileni kwabantu, ukuvikela kanye nokukhuthazwa kwezempilo yomphakathi ekuqaleni. umgomo, ngezidingo “ezine eziqine kakhulu” njengesiqondiso esiyisisekelo, ukujulisa uguquko, futhi kujulise ukukhuthazwa kwawo wonke umsebenzi kuzuze imiphumela emangalisayo. Umsebenzi uthole imiphumela emangalisayo.
Ngokuhamba kweminyaka, Isikhungo Sokubukeza Ubuchwepheshe Bedivayisi Yokulawulwa Kwezidakamizwa sikahulumeni (ngemuva kwalokhu esizobizwa ngokuthi Isikhungo) ekubambeleleni ekuthuthukisweni okuqhutshwa emisha, ukwakha nokuthuthukisa uhlelo ukuze kugqugquzelwe ukuqamba okusha; ukugqugquzela ukufika kwamaphrojekthi amakhulu kazwelonke, okugxile ekuxazululeni inkinga "yentamo"; ukuqedwa ngokwesayensi nangempumelelo kwempendulo yezimo eziphuthumayo ekubuyekezweni, ukuqinisekisa ukuthi umqhele omusha wokuvimbela nokulawula ubhubhane, njll. usebenzisa uchungechunge lwezinhlelo, izinhlobo ezibalulekile zezinhlobonhlobo zokuqaliswa "kokungenelela kusenesikhathi, inqubomgomo yebhizinisi, yonke inqubo yokuqondisa, ucwaningo kanye nokuxhumana kokubuyekezwa”, ukukhuthaza imboni yezemithi, izinga eliphezulu lokuzethemba kwezesayensi nobuchwepheshe kanye nokuzimela, ukuhlangabezana ngokuphumelelayo. umphakathi okwaziyo ukufinyelela, futhi othengekayo esidingweni esiphuthumayo sezikhali ezintsha, kanye nokuvikela ngempumelelo amalungelo nezintshisakalo zempilo yomphakathi jikelele.
Namathela kudrayivu yokusungula
Ukusiza ukuthuthukisa kancane kancane ukuncintisana kwemboni
Umbiko weNgqungquthela Kazwelonke ye-CPC yama-20 ugcizelela ukuthi kufanele siphikelele ekusungulweni kwezinto ezintsha njengamandla okuqala okushayela, sisebenzise ngokujulile isu lentuthuko eliqhutshwa emisha, sivule imikhakha emisha nemikhondo emisha yentuthuko, futhi silolonge ngokuqhubekayo umfutho omusha kanye nezinzuzo ezintsha; ukusheshisa ukufezeka kokuzethemba okusezingeni eliphezulu kwezesayensi nezobuchwepheshe, futhi okuqondiswa yizidingo zamasu kazwelonke, ukuqoqa amandla okwenza ucwaningo nokuthuthukiswa kwesayensi nobuchwepheshe, ukunqoba ngokuqinile impi yobuchwepheshe obuyinhloko. , futhi kusheshiswe ukuqaliswa kwenani lamaphrojekthi kazwelonke amakhulu esayensi nezobuchwepheshe, namasu amakhulu abheke phambili, kanye nokuqaliswa uchungechunge lwamasu namaphrojekthi aphelele esayensi nezobuchwepheshe. Sizosheshisa ukuqaliswa kwenani lamaphrojekthi amakhulu kazwelonke esayensi nezobuchwepheshe anamasu kanye nokubaluleka komhlaba wonke, futhi sithuthukise amandla okusungula izinto ezimele.
Umbiko weNgqungquthela Kazwelonke ye-CPC yama-20 uveze isiqondiso esisebenzayo sokukhuthaza ukusungulwa kwemishini yezokwelapha ngaphansi kwesimo esisha. Eminyakeni yamuva nje, ukusekelwa kwemishini emisha yesayensi nobuchwepheshe baseChina kusebuthakathaka, ikhwalithi yemikhiqizo esohlwini kanye nezinga elithuthukisiwe lamazwe ngamazwe legebe phakathi kwesimo sangempela, imishini yezokwelapha ukukhuthaza emisha ukukhuthaza ukuhlelwa kabusha kwezimboni kanye nokusungulwa kwezinto zobuchwepheshe, ukuthuthukisa izimboni. ukuncintisana njengomgomo, ukulinganisa umqondo othuthukisiwe wamazwe ngamazwe wokuqamba kanye nokuqondisa, ukuhlela isikhathi eside kanye nokuqaliswa kancane kancane kokuqanjwa kabusha nokuthuthukiswa kokuhlaziywa kwesimo nocwaningo, uguquko yempumelelo emisha yokuqinisekisa izidingo zokwakhiwa nokusebenza kwesiteshi okubalulekile okubalulekile kanye nezinye izinhlelo, futhi kuzuzwe inani lamaphrojekthi amakhulu kazwelonke anamasu nabheke phambili ukuze kuthuthukiswe ikhono elizimele lokuqamba. Ukuhlelwa kwesikhathi eside nokuqaliswa kancane kancane kwezinhlelo ezinjengokuhlaziya nokwahlulela isimo sokuthuthukiswa kokusungula izinto ezintsha, ukuqinisekisa isidingo soguquko lwempumelelo emisha, nokwakha nokusebenzisa imigudu ebaluleke kakhulu yokusungula kuzuze imiphumela emangalisayo.
Ukukhuthaza ukufakwa kuhlu okusheshayo kwemishini yezokwelapha emisha
Ngo-2014 nango-2017, iziphathimandla zikazwelonke ezilawula izidakamizwa zamisa ngokulandelanayo isiteshi sokubuyekeza esikhethekile semishini emisha yezokwelapha kanye nesiteshi sokugunyaza okubalulekile semishini yezokwelapha. Selokhu kwasungulwa le migudu emibili, iSikhungo sisebenzise ngobuqotho izidingo ezifanele zeNqubo Yokubuyekeza Okukhethekile Yamadivayisi Ezokwelapha Athuthukile kanye Nenqubo Yokugunyazwa Okubalulekile Yamadivayisi Ezokwelapha, samisa Ihhovisi Lokubuyekeza Okusha kanye Nehhovisi Lokucwaninga Okubalulekile, futhi senza inqubo yokubuyekeza yaba iphelele. kanye nokwakhiwa kwesistimu yeshaneli yokubuyekeza ngokushesha yemishini yezokwelapha enezidingo ezintsha, ezisezingeni eliphezulu neziphuthumayo, ukuze kuthuthukiswe ukungena kokusha kanye nokuphuthuma ngokomtholampilo. ezidingekayo zezokwelapha zingene esiteshini sokubuyekeza ngokushesha. Ekupheleni kuka-2023, imishini yezokwelapha emisha engama-251 kanye nemishini yezokwelapha eseqhulwini eyi-138 isithuthelwe ngokushesha emakethe ngesiteshi esiluhlaza, okuhlanganisa nochungechunge lwemishini emisha, yobuchwepheshe obuphezulu kanye nemishini yezokwelapha ephuthumayo njengohlelo lwe-carbon ion therapy, i-proton. uhlelo lokwelapha, inhliziyo yokwenziwa, irobhothi elihlinzayo, i-extracorporeal membrane oxygenation (ECMO), njll., egcwalisa ngempumelelo izikhala emikhakheni efanele, kanye ukwanelisa kangcono isidingo sabantu sokusebenzisa imishini yezokwelapha esezingeni eliphezulu. Lokhu kugcwalise ngempumelelo izikhala emikhakheni efanele futhi kwahlangabezana kangcono nesidingo sabantu semishini yezokwelapha esezingeni eliphezulu.
Njengomnyango ophethe wokubuyekezwa kwemishini yezokwelapha emisha kanye nokubuyekezwa okubalulekile kwemishini yezokwelapha, iSikhungo sisungule futhi sathuthukisa kancane kancane izinkambiso zangaphakathi zokusebenza zalezi zindaba ezimbili, ezihlanganisa ikakhulukazi ukucwengisiswa kwezidingo zokubuyekeza, ukucacisa izindlela zokusebenza, kanye nokuhlanganisa izimiso zokusebenza. ukwamukela imibono, njll. Ngesikhathi esifanayo, Isikhungo sikhiphe “Ukubuyekezwa Okukhethekile Kwedivayisi Yezokwelapha” kanye “Nokubuyekezwa Okukhethekile Kwedivayisi Yezokwelapha”. Ngesikhathi esifanayo, Isikhungo sikhiphe “Iziqondiso Zokulungiselela Ulwazi Lwezimemezelo Zokubuyekezwa Okukhethekile Kwamadivayisi Ezokwelapha Ezintsha”, ezicacisa izidingo zokulungiselelwa nokubhala imininingwane yesimemezelo ukuze kusetshenziswe imishini yezokwelapha emisha, futhi inikeza isiqondiso esiqondile. kubafakizicelo nabasebenzi be-R&D. Ukuze kuqinisekiswe ukuqaliswa okushelelayo kwezinqubo zomsebenzi, iSikhungo siphinde sasungula imigudu yokuxhumana yemikhiqizo yemishini yezokwelapha emisha futhi ebaluleke kakhulu, futhi samisa inkundla yokubonisana nge-inthanethi ukuze kuthuthukiswe ukuqaliswa kokusebenza kahle nokuhlelekile komsebenzi ohlobene.
Ukuqinisekisa ukubuyekezwa kanye nokucwaningwa kwamabhuku kwezesayensi nokungenzeleli Ukuqinisekisa izinga lomsebenzi wokubuyekezwa kokusungula kanye nokubuyekezwa okubalulekile, I-Instrument Review Centre isungule ukubuyekezwa okuhlanganyelwe kanye nendlela yokucwaningwa kwamabhuku, eholwa ubuholi obungamele besikhungo, Ihhovisi Lokubuyekezwa Kwezinto Ezintsha kanye Nokubuyekezwa Okubalulekile. Ihhovisi elizosebenza. Amalungu amahhovisi amabili yi-State Drug Administration Division of Medical Device Registration, Instrumentation Review Center, i-Chinese Biomedical Engineering Society, i-Chinese Society for Biomaterials abasebenzi abafanelekile, ngendlela yamalungu omsebenzi azohlelwa ngendlela ye- imihlangano yokubuyekeza kanye nokucwaningwa kwamabhuku, ukubuyekezwa kochwepheshe kwemibono nezindaba ezihlobene nocwaningo oluyiqoqo kanye nokuthathwa kwezinqumo.
Ukusetshenziswa okuphumelelayo nokungokwesayensi kwezinsiza zochwepheshe bangaphandle kusiza ekuthuthukisweni kwekhwalithi yomsebenzi wokubuyekezwa kokuqamba okusha kanye nokubuyekezwa okubalulekile. Ichibi lochwepheshe lokubuyekezwa kobuchwepheshe bemishini yezokwelapha yethulwa ngokusemthethweni ngoNdasa wezi-2017, kanti iCentre for Instrumental Review isungule uhlelo olusekelayo lokuphathwa kochwepheshe bangaphandle ukuze kumiswe ukwakheka, ukukhethwa, ukusebenza kwansuku zonke kanye nomunye umsebenzi wochwepheshe bokubuyekeza. ichibi. Mayelana nokusebenza komhlangano wokubonisana nochwepheshe, iye yahlola ukusungulwa kwendlela yokukhetha ochwepheshe abangaboni ngaso linye, yathuthukisa indlela yomhlangano wokubonisana nochwepheshe, yagwema ukungenelela kwabantu ekubuyekezweni kochwepheshe ngezinga elikhulu kakhulu elingenzeka, futhi yaqinisekisa ukuthi ubuqotho, ukungakhethi kanye nempumelelo yesayensi yomsebenzi wokubuyekeza. Njengamanje, iqoqo lochwepheshe lingaphansi kokuphathwa okunamandla, futhi ngokomthetho, lihlukaniswe ukusetshenziswa komtholampilo kwemishini yezokwelapha ye-Class III, futhi sekusungulwe amakomiti abeluleki bochwepheshe abayi-17, futhi ukukhethwa kwamaqoqo ama-5 ochwepheshe bangaphandle sekuqediwe. , ngochwepheshe bangaphandle abayizi-2,374 (kuhlanganise nezifundiswa ezingama-41), okubandakanya amakhono ayi-119 kanye neziqondiso zocwaningo ezingama-244.
Ukusheshisa Ukubuyekezwa Kwemikhiqizo Ebalulekile Emisha Kumathuluzi ezokwelapha asungulayo anamalungelo azimele empahla yengqondo, ezingeni elihamba phambili lamazwe ngamazwe, anenani elibalulekile lesicelo somtholampilo, kanye nemishini yezokwelapha enesidingo esiphuthumayo somtholampilo, esekelwa amaphrojekthi kazwelonke akhethekile kanye nezinhlelo zikazwelonke ezibalulekile ze-R&D, Isikhungo siqhubekile nokusebenzisa ukubuyekezwa okubalulekile ngokuhambisana nomgomo wokungehlisi amazinga kanye nokuyisa izinsiza phambili. Isikhungo siyaqhubeka nokuthuthukisa inqubo yokubuyekezwa kobuchwepheshe yemikhiqizo emisha ebaluleke kakhulu, futhi sigxile emtholampilo, sigxile kubabuyekezi abaphezulu abavela eminyangweni ehlukahlukene yokubuyekeza ukuze sakhe ithimba elizobuyekezwa ngokuhlanganyela, nemibono yokubuyekeza ebanzi evezwa amathimba ezokwelapha, ezobunjiniyela namanye amaqembu ochwepheshe. Phakathi nenqubo yokubuyekeza, ababuyekezi bathunyelwa ukuze babambe iqhaza ekuqinisekiseni uhlelo lokulawulwa kwekhwalithi yokubhalisa ngendlela yokubuyekeza endaweni, ukuze baqonde ngokujulile nangokuphelele imikhiqizo emisha nebekwe eqhulwini futhi babeke phambili imibono yokubuyekeza yesayensi nenengqondo. Ngaphezu kwalokho, iphinde ihlanganise indlela yokuqondisa ekuphathweni kwephrojekthi kanye nokulawulwa kwekhwalithi ukuze kufinyelelwe ukufinyezwa okusebenzayo kwesikhathi sokubuyekezwa komkhiqizo uma kuqhathaniswa nomkhawulo wesikhathi wokubuyekeza osemthethweni.
Ukukhuthaza Ukuguqulwa Kwezimpumelelo Ezisungulwe Izidingo Zomtholampilo
Ukuhlolwa komtholampilo kuyisixhumanisi esibalulekile sokulawula ohlelweni lokufakwa kuhlu lwemishini yezokwelapha emisha. Eminyakeni yamuva nje, iSikhungo senze uchungechunge lomsebenzi emkhakheni wokuhlolwa komtholampilo kwemishini yezokwelapha, kancane kancane salungisa umqondo wokubuyekeza, izidingo kanye nohlaka lokuhlolwa komtholampilo kwemishini yezokwelapha, yacebisa futhi yandisa imithombo yedatha yomtholampilo, yaxazulula eziningi. izindaba ezibalulekile ezifana nokuthi kwenziwa kanjani ukuhlolwa komtholampilo, futhi kwakhiwe izindlela ezintsha namathuluzi okuhlolwa komtholampilo, futhi ngokuyisisekelo kwakha umqondo wokuhlolwa komtholampilo wesayensi. Ekubuyekezweni kwemikhiqizo ethile, indlela yokuhlolwa komtholampilo yemikhiqizo ehlukahlukene ngokuyisisekelo ifinyelele ukuvumelana kuma-ejensi alawulayo kanye nemboni, futhi ingxenye yezivivinyo zomtholampilo ekubhalisweni komkhiqizo namaphrojekthi okushintsha amalayisensi isezingeni elifanele.
Ukwakha uhlelo olujwayelekile lokubuyekezwa kobuchwepheshe kokuhlolwa komtholampilo Eminyakeni yamuva nje, iSikhungo senze imibhalo yokuxhumana yamazwe ngamazwe ukuze ihlolwe umtholampilo futhi ngokulinganayo yashintsha yaba imibhalo yaseShayina evamile, futhi yakha izimiso ezijwayelekile eziyi-8 nezindlela ezinconyiwe ezingu-22 zokuhlolwa komtholampilo, ezihlanganisa ngokuphelele. izingqinamba ezibalulekile emkhakheni wokuhlolwa komtholampilo. Khonamanjalo, sekusungulwe uhlelo olunezigaba ezintathu lokubuyekezwa kobuchwepheshe ngohlaka “lwezimiso ezijwayelekile eziyisiqondiso sokuhlolwa komtholampilo - izimiso eziqondisayo zokuhlolwa komtholampilo kwezinhlobo ezihlukahlukene zemikhiqizo - amaphuzu abalulekile okubuyekezwa kobuchwepheshe kokuhlolwa komtholampilo kwezinhlobo ezihlukahlukene zemikhiqizo" . Njengamanje, ngesisekelo sezimiso ezijwayelekile zokuqondisa, izimiso eziqondisayo ezingaphezu kuka-70 zokuhlolwa komtholampilo kwezinhlobo ezahlukene zemikhiqizo kanye namaphuzu abalulekile angaphezu kuka-400 okubuyekezwa kobuchwepheshe kokuhlolwa komtholampilo kuye kwasungulwa, ngokuyisisekelo kutholwa ukumbozwa okuphelele kwemikhiqizo leyo. idinga ukuhlolwa ngokomtholampilo ngaphansi kwekhathalogi yezigaba ezintathu ze-Classification Catalog of Medical Devices, kanye nokuzuza ukuhlolwa komtholampilo kwezokwelapha. amadivayisi anobubanzi obucacile bemikhiqizo, indlela ecacile yokuhlola kanye nezidingo ezithile zokuhlola, ezinikeza imihlahlandlela eyisisekelo yokwenziwa kokuhlolwa kwemitholampilo kwemishini yezokwelapha emisha. Inikeza isiqondiso esiyisisekelo semishini yezokwelapha emisha ukuze yenze izivivinyo zomtholampilo.
Ukuthuthukisa ukufinyeleleka kwemikhiqizo emisha Ukuthuthukisa ukufinyeleleka kwemikhiqizo emisha ukuze isetshenziswe emtholampilo kuyisixhumanisi esibalulekile sokuhlangabezana nezidingo zokwelapha zeziguli ezinezifo ezisongela ukuphila. ISikhungo siqhubekile nokunaka izindaba ezibalulekile kule ndawo futhi sesenze isiphakamiso sezinhlelo ezifanele zokuqaliswa kwazo. Isibonelo, Isikhungo senze ucwaningo ngokugunyazwa okunemibandela kwemishini yezokwelapha, sahlola ngokucophelela ubungozi nezinzuzo zemikhiqizo, futhi salungisa izimfuneko zokugunyazwa okunemibandela, sikhuthaza ukugunyazwa okunemibandela kwemishini yezokwelapha esetshenziselwa ukwelapha izifo ezisongela ukuphila. futhi okungekho ukwelashwa okusebenzayo okutholakalayo ngokushesha ngangokunokwenzeka; yenze nocwaningo ngokunwetshwa kokusetshenziswa kwemishini yezokwelapha emisebenzini yokwelapha, yacacisa izidingo zokwandisa izivivinyo zomtholampilo, futhi yakhuthaza ukusetshenziswa komtholampilo kwemishini yezokwelapha esetshenziselwa ukwelapha izifo ezisongela ukuphila ezikhona. akukho ukwelashwa okusebenzayo. Ukukhuthaza ukusetshenziswa komtholampilo kwemishini yezokwelapha ekwelapheni izifo eziyingozi kakhulu ezingenazo izindlela zokwelapha ezisebenzayo, kanye nokuhlangabezana nezidingo eziphuthumayo zeziguli ezithile zokwelapha ngokwezinga eliphezulu ngangokunokwenzeka ngenkathi kuqinisekiswa ukuphepha kokusetshenziswa komphakathi imishini yezokwelapha; ukuqhubekisela phambili kancane kancane umsebenzi wokuhlola wokusebenzisa idatha yomhlaba wangempela e-Boao Lecheng, ukusungula izindlela zokuhlola umtholampilo, futhi uhlole ngenkuthalo indlela yokusebenzisa idatha yomhlaba wangempela yokubhaliswa komkhiqizo. Ukuphendula lezi zinyathelo ezingenhla, iye yakha ngokulandelana Izimiso Eziqondisayo Zokuvunyelwa Okunemibandela Kwamadivayisi Ezokwelapha Ukuze Afakwe ohlwini, Izimiso Zokuqondisa Zezobuchwepheshe Zokuhlolwa Komtholampilo Kwedatha Yangempela Yezwe Yamadivayisi Ezokwelapha (Yokusebenza Kokuhlolwa), futhi yabamba iqhaza ekwakhiweni kwe Imishini Yezokwelapha
Gxila emizamweni yokugxilisa ingqondo
Gxila ekuxazululeni inkinga "yentamo".
UNobhala Jikelele u-Xi Jinping ubheka ukubaluleka okukhulu kubuchwepheshe obuyinhloko. Ugcizelele ukuthi kufanele sigxile ocwaningweni lwezobuchwepheshe oluyisihluthulelo, sisheshise isisombululo semithi eminingi, imishini yezokwelapha, imishini yezokwelapha, imigomo kanye nezinye izindawo zenkinga "yentamo"; ukusheshisa ukulungisa ibhodi elifushane lemishini yezokwelapha yaseShayina esezingeni eliphezulu, ukusheshisa ucwaningo oluyisihluthulelo lobuchwepheshe, ukuphumelela kulezi zinkinga zemishini yezobuchwepheshe, kanye nokuqaphela imishini yezokwelapha esezingeni eliphezulu ezimele nelawulekayo; ukuqinisa ucwaningo oluyisisekelo kanye nokwakhiwa kwamakhono esayensi nezobuchwepheshe, futhi sibeke impilo yentuthuko yemboni yezokwelapha ngokuqinile ezandleni zethu. Ucwaningo oluyisisekelo kanye nokwakhiwa kwamakhono esayensi nezobuchwepheshe, impilo yokuthuthukiswa kwemboni yezokwelashwa ngokuqinile ezandleni zethu.
Ukuze kuxazululwe inkinga "yentamo" emkhakheni wemishini yezokwelapha, ukubuyekezwa kwezobuchwepheshe kwemishini yezokwelapha kuhlonze amaphuzu amathathu abalulekile, okugxile ekuhlanganisweni kwezinsiza ezintsha, ukuthuthukiswa kwimodi yomsebenzi, ukuphumelela ezindabeni ezibalulekile ukuqala ucwaningo nokubeka. dlulisela phambili izinhlelo ezihambisanayo zokuqalisa. Ekuhlanganisweni kwezinsiza ezintsha, ezisekelwe ekugqugquzeleni izinsiza zokubuyekeza, uhulumeni ohlanganyelwe, izimboni, izifundiswa, ucwaningo kanye nokusetshenziswa kwazo zonke izinhlangothi, emkhakheni wezobunhloli bokwenziwa kanye nama-biomaterials ukuze kwakheke ukuvuleka nokwabelana ngokusungula kanye nokubambisana; ekusungulweni kwemodeli yomsebenzi, ucwaningo, ukukhuthaza ukubuyekezwa kwesikhungo samandla adonsela phansi kancane kancane kuya esigabeni sokuthuthukiswa komkhiqizo, ukuqaliswa kokubuyekezwa kwangaphambili kwedivayisi yezokwelapha; ekuthuthukisweni kwezingqinamba ezibalulekile, ubuso bokusheshisa ukwenza ibhodi elifushane lemishini yezokwelapha yaseChina yesimo esiphuthumayo. Mayelana nokugqekeza ezindabeni ezibalulekile, lapho kubhekwa isimo esiphuthumayo sokusheshisa ukwakha ibhodi elifushane lemishini yezokwelapha esezingeni eliphezulu eChina, kwenziwe ucwaningo olunzulu nokusekelwa kwemishini yezokwelapha esezingeni eliphakeme yasekhaya, futhi imiphumela ethile isizuziwe.
Ukwakha Iplathifomu Yokusungula Nokubambisana Okuvulekile Nokwabelwana Ngayo
Ukuze sibambe umkhankaso wamasu womjikelezo omusha woguquko lwesayensi nobuchwepheshe futhi sigxile ezindaweni ezibalulekile zokukhuthaza ukufakwa kuhlu kwemishini yezokwelapha emisha yasekhaya, iSikhungo sakhe uhlelo olusha oluvulekile noluhlanganyelayo lokusungula idivayisi yezokwelapha emikhakheni yobuhlakani bokwenziwa. kanye nama-biomaterials ngesisekelo sokuhlaziya nokwahlulela isimo sokuthuthukiswa komkhakha wemishini yezokwelapha yaseChina, silwela ukumisa inkundla yokuqamba kanye nokubambisana. ukuze kugadwe isayensi yemishini yezokwelapha, ukusungulwa kwesayensi nobuchwepheshe, kanye nokuguqulwa komkhiqizo ukuze kwakheke inkundla yokusungula izinto ezintsha zesayensi nezobuchwepheshe, ukuguqulwa kwempumelelo, ukugadwa kukahulumeni, nokuguqulwa komkhiqizo. Izama ukwakha inkundla yokubambisana emisha ukuze isebenzele ukugadwa kwesayensi kwemishini yezokwelapha, ukusungulwa kwesayensi nobuchwepheshe kanye nokuguqulwa kwemikhiqizo, nokudala isimo esihle sokusebenzisana sokusungula izinto ezintsha zesayensi nezobuchwepheshe, ukuguqulwa kwempumelelo, ukugadwa kukahulumeni kanye nokuzilawula kwemboni.
Kusukela yasungulwa futhi yasebenza ngoJulayi 2019, i-Artificial Intelligence Medical Device Innovation Cooperation Platform yakhe ngempumelelo izidingo zobuchwepheshe zedivayisi yezokwelapha yase-China, izindlela zokuhlola nezinye izinhlelo ezijwayelekile ezihambisanayo, kanye nemihlahlandlela ebalulekile njengokuthi “Amaphuzu Abalulekile Okubuyekeza Ukufunda Okujulile- Isoftware Esizwayo Yokwenza Izinqumo Yamadivayisi Ezokwelapha", "Amaphuzu Abalulekile Wokubuyekezwa Kwe-Pneumonia CT Imaging Assisted Isoftware Yokuhlola Nokuhlola (Isivivinyo)”, kanye “Nemihlahlandlela Yokubuyekezwa Kokubhaliswa Kwamadivayisi Ezokwelapha Obuhlakani Okwenziwayo” yenziwe futhi yakhululwa ngokulandelana. Izimiso zenziwe zakhululwa ngokulandelana, zinikeza isiqinisekiso esiyisisekelo esidingekayo sokuthuthukiswa kwemboni yemishini yezokwelapha ye-AI. Ngaphezu kwalokho, inkundla iphinde yakha ngempumelelo imininingwane yolwazi yoqobo yokuhlolwa okuhlanganisa izindawo eziningi zezifo ezifana ne-fundus ultrasound ye-retinopathy yesifo sikashukela, i-CT ye-pneumonia, i-ultrasound yegilo, njll. Imininingo egciniwe efana nezithombe ze-cytopathic yomlomo wesibeletho kanye nemifanekiso ehlukahlukene ye-myopia ye-pathological isakhiwa, ihlinzeka ngendlela yokuqoqwa, ukuphathwa, kanye nokusetshenziswa kwedatha ukuze imikhiqizo ye-AI ihlanganiswe futhi kwabelwane ngayo.
Kusukela yasungulwa ngo-Ephreli 2021, i-Biomaterials Innovation Cooperation Platform ibambe iqhaza ekwakhiweni kwezimiso eziqondisayo, amaphuzu okubuyekeza nemihlahlandlela yobuchwepheshe ehlanganisa imikhakha eyahlukene efana nama-in vitro diagnostic reagents namadivayisi, ukukhiqiza okungeziwe, amadivaysi e-ECMO nezinto zokuzilungisa zezokwelapha, ekhuthaze ukuguqulwa kanye nokusetshenziswa kwezimpumelelo zesayensi nezobuchwepheshe emkhakheni we-biomaterials kanye nobuchwepheshe obubalulekile insimu yemishini yezokwelapha. Ngokusekelwa kweplatifomu, inqubekelaphambili yentuthuko yenziwe endaweni yezinto zokusetshenziswa ezincike ekungeniseni ezifana ne-polyether ether ketone materials (PEEK) zokufakelwa; I-China iyaqhubeka nokuhola inkundla yamazwe ngamazwe emkhakheni wezinto eziwusizo ze-biomedical, njenge-sodium hyaluronate …… isigaba esiholayo semikhiqizo emisha siyaqhubeka nokwanda.
Hlola ukusungulwa kwendlela yokusebenza yokubuyekeza kuqala
Ngesisekelo sokufingqa nokuhlaziya ukusebenza kahle kwezinguquko zokubuyekezwa kwemishini yezokwelapha kanye nohlelo lokugunyazwa, i-Center for Instrumental Review yalinganisela imodeli yokubuyekeza okuthuthukile yamazwe ngamazwe, futhi kancane kancane yakha imibono emisha yokubuyekeza umsebenzi, futhi yahlola ngenkuthalo ingxenye yezinsiza zokubuyekeza. ekupheleni kokuthuthukiswa komkhiqizo wokuqhubekela phambili kwemodeli yomsebenzi. Esikhathini esidlule, ukuthunyelwa kwamalungiselelo okubuyekezwa kobuchwepheshe bemishini yezokwelapha kanye nokuhlolwa kwesikhungo esingaphansi kwe-Yangtze River Delta kanye Nesikhungo Sesifunda Sesifunda sase-Bay Area ezinikezelwe ukuqondisa indawo yokucwaninga nokuthuthukiswa komkhiqizo obalulekile, ucwaningo olujulile nokuhlolwa. yemikhiqizo yasekhaya esezingeni eliphezulu, ezithuthukisiwe ukuze ingenelele kusenesikhathi esivivinyweni sokuthuthukiswa komkhiqizo, kodwa futhi evumelaniswe nocwaningo lokubuyekezwa kwesikhungo somandla adonsela phansi. yokudlulela phambili kokuqaliswa kwenqubo ethile, izindlela zokuhlola umkhiqizo, izindlela zokulawulwa kwephrojekthi yokudokha okuzinikele kanye neminye imininingwane. 2022 Ngo-2022, uhulumeni uzokwethula ngokusemthethweni ukubuyekezwa kwemishini yezokwelapha, akhiphe “Ikhodi Yokusebenza Yokubuyekezwa Kwemiklamo Ebalulekile Nemikhiqizo Ebalulekile Yokubuyekezwa Kobuchwepheshe Kwamadivayisi Ezokwelapha (Okusebenza Kokuhlolwa)”, ahlole amaphrojekthi abalulekile kanye nezokwelapha. amadivayisi anobuchwepheshe obuyinhloko kanye nenani elibalulekile lesicelo somtholampilo, futhi akhuthaze ukubuyekezwa kokubuyekezwa kokungenelela kusenesikhathi ocwaningweni olusha nokuthuthukiswa kwemikhiqizo ngokungenelela kusenesikhathi, okukodwa. ibhizinisi, inqubomgomo eyodwa, isiqondiso senqubo yonke, nokuxhumana kocwaningo nokubuyekezwa.
Sekela ucwaningo nokuthuthukiswa kwemishini yezokwelapha esezingeni eliphezulu
Imishini yezokwelapha yaseChina ephezulu ikhona engxenyeni yezithiyo zenqubo ebalulekile, izinga lokukhiqiza umshini liphansi uma kuqhathaniswa nezinye. Ukuze kuxazululwe lezi zinkinga ezingenhla, iSikhungo sigxile ezidingweni zamasu kazwelonke zokucabanga okusebenzayo, ukuhlela okusebenzayo, ukuphatha kahle imboni kanye nokuhamba phambili kwentuthuko yesayensi nezobuchwepheshe, kanye nokuqongelela njalo izinqubo ezibalulekile kanye nemithombo yobuchwepheshe eyisisekelo, esekela umnyombo oyinhloko. ucwaningo nokuthuthukiswa kobuchwepheshe, ukusheshisa ukugcwaliseka kwenqubo yokwenziwa kwendawo kwemishini yezokwelapha ephezulu, nokusheshisa ukwenza ibhodi elifushane lemishini yezokwelapha ephezulu. Sizokwenza ucwaningo olunzulu ngesimo samanje se-"choke point" yezinto zokusetshenziswa kwezokwelapha (izingxenye), ukwandisa ukusekelwa kwemishini yezokwelapha ephezulu enezingxenye ezizimele ezithuthukisiwe ezifana ne-ECMO, i-helium magnetic resonance magnetic resonance, njll., nokwenza izinhlobo ezahlukene zocwaningo kanye nokuxhumana okusebenzayo. Ngo-2022, uhlelo lokuqala lokwelapha lwe-proton olwakhiwe ekhaya, okokuqala okufakelwayo kwezokwelapha okufakelwayo ngobuchwepheshe be-levitation ka-magnetic-liquid, kanye nemishini yezokwelapha yokuqala efakelwayo enobuchwepheshe be-magnetic-liquid levitation izothuthukiswa emakethe yasekhaya. uhlelo lokusiza lwe-ventricular kwesokunxele olufakelwayo olusebenzisa ubuchwepheshe bokumisa uketshezi kazibuthe luzovunyelwa futhi ludayiswe, futhi uhlelo lwe-carbon ion therapy luzobe seluqedile ukuguqulwa nokuthuthukiswa kwalo; ngo-2023, imikhiqizo emithathu yemishini ye-ECMO ekhiqizwe ekhaya izogunyazwa futhi idayiswe, futhi inkinga yamabhodi amafushane emishini yezokwelapha esezingeni eliphezulu e-China izoxazululwa ngendlela eqhubekayo nephumelelayo.
Ukunamathela Kubantu Kuqala
Imizamo yonke yokuvikela ukuvikela nokulawula ubhubhane
NgoZibandlela wezi-2019, ubhubhane olusha olusanda kwenzeka lwasongela kakhulu izimpilo nokuphepha kwezempilo kwabantu. UNobhala Jikelele u-Xi Jinping wenze imiyalelo ebalulekile yokuvimbela nokulawulwa kwalolu bhubhane. Ngaphansi kobuholi obuqinile beqembu leqembu le-State Drug Administration, ukubuyekezwa kwezobuchwepheshe kwemishini yezokwelapha, okuholwa umcabango kaXi Jinping wokusebenzelana kwabantu abanezici zaseShayina enkathini entsha, kwafeza ngobuqotho izidingo “zezine eziqine kakhulu”, ezilandelwa umgomo wokubeka ukuphepha nempilo yabantu endaweni yokuqala, ngokuvumelana “nomyalo obumbene, ukungenelela kusenesikhathi, ukugunyazwa kwesayensi”, kanye “nokune okuqinile” izidingo, Ngokuhambisana nezimiso "zomyalo obumbene, ukungenelela kusenesikhathi, ukubuyekezwa kwendawo kanye nokugunyazwa kwesayensi" kanye nezimfuneko zokuqinisekisa ukuphepha komkhiqizo, ukusebenza kahle kanye nekhwalithi elawulekayo, siqedele umsebenzi wokubuyekeza izimo eziphuthumayo ngekhwalithi ephezulu, esinikeze isiqinisekiso esisebenzayo sokuvimbela nokulawulwa kwalolu bhubhane.
Ukukhishwa kwezindawo zokubuyekeza izimo eziphuthumayo
Ngemva kokuqubuka kwalolu bhubhane, i-State Drug Administration (SDA) yaqala inqubo yokugunyaza izimo eziphuthumayo zemishini yezokwelapha ngesikhathi sokuqala, futhi yanquma ububanzi bemikhiqizo okufanele ifakwe ekugunyazweni kwezimo eziphuthumayo. Ukuze kusekelwe abakhiqizi ukuthi bakhe ama-reagents amasha okuhlonza i-coronavirus ukuze kuvinjwe futhi kulawulwe ubhubhane ngokushesha ngangokunokwenzeka futhi kubhaliswe ngempumelelo emakethe, kubaluleke kakhulu ukukhipha imibhalo yokuqondisa ngesikhathi ukuze iqondise ukuthuthukiswa nokubhaliswa komkhiqizo. Ngesisekelo sokuqoqa izincwadi ezifanele nokucela imibono yochwepheshe, iCentre for Instrumental Review (CIR) icwaninge futhi yakha futhi yakhipha emhlabeni wonke “Amaphuzu Abalulekile Okubuyekezwa Kobuchwepheshe Kokubhaliswa Kwama-2019 Novel Coronavirus Nucleic Acid Detection Reagents” kanye “nokhiye Amaphuzu Okubuyekezwa Kwezobuchwepheshe Kokubhaliswa Kwe-2019 Novel Coronavirus Antigen/Antibody Detection Reagents”, okuhloswe ngazo ukuhlinzeka ngesiqondiso kubafakisicelo ekulungiseleleni ulwazi lwesimemezelo, ukuqinisekisa ikhwalithi yokubuyekezwa, futhi kusheshiswe ukugunyazwa kwama-reagents amasha okuhlola i-coronavirus ukuze asetshenziswe ekuvimbeleni nasekulawuleni ubhubhane. Ama-reagents amasha okutholwa kwe-coronavirus emakethe ahlinzeka ngesisekelo sobuchwepheshe. Phakathi nalolu bhubhane, Imihlahlandlela Yokubuyekezwa Kokubhaliswa Kwama-Antigen Detection Reagents E-New Coronavirus (2019-nCoV), Imihlahlandlela Yokubuyekezwa Kwe-Pneumonia CT Imaging Assisted Diagnosis and Evaluation Software (Trial), Izeluleko Zokubuyekezwa Kwamadivayisi E-Extracorporeal Membrane Lung Oxygenation (ECMO) , kanye neminye imibhalo ebalulekile eyisiqondiso yenziwe futhi yakhululwa ngokuvumelana nesimo yokulwa nobhubhane, ehlinzeka ngemihlahlandlela esebenzayo yokubuyekezwa kobuchwepheshe kanye nocwaningo nokuthuthukiswa kwemikhiqizo yebhizinisi.
Ukwenza isibuyekezo esiphuthumayo
Hamba ngama-oda futhi uthathe imithwalo esindayo. Ngemva kokuba i-State Drug Administration yethule inqubo yokugunyaza izimo eziphuthumayo, i-Centre for Instrumental Review (CIRC) ibisebenzisa ngokuphuthumayo umsebenzi wokubuyekeza izimo eziphuthumayo, igqamisa izici zesayensi nokusebenza kahle okuphezulu, nokulawula ngokuqinile ikhwalithi yemikhiqizo. Ngokwakhiwa kwesayensi kokuphepha komkhiqizo kanye nemodeli yokuhlola ephumelelayo, senza ukwahlulela okunembile kuzimfuneko zokubuyekezwa kwemikhiqizo emisha ehlukahlukene, sixhumana ngokuphumelelayo nokuhlola, ukuhlolwa kwesistimu nokubuyekezwa kwezindaba eziyingxenye emithathu, futhi sikhuthaze ngokuhlanganyela isibuyekezo esiphuthumayo. I-Specific modus operandi Yeqembu Lokusebenza Lokubuyekeza Okuphuthumayo ihlanganisa ukungenelela ekuthuthukisweni komkhiqizo kusenesikhathi, ukuxhumana ngokuqondile nethimba le-R&D, ukuqonda isimo se-R&D, nokuqondisa ukwakheka komkhiqizo nezindlela zokuthuthukisa; ukwenza ukuhlolwa kobuchwepheshe okufika ngesikhathi kwemikhiqizo ezomenyezelwa, kanye nokuqondisa abafake izicelo zokubhalisa ukuthi benze umsebenzi wokumemezela ukubhalisa okokuqala; ukwenza ukubuyekezwa kwansuku zonke kolwazi oluthunyelwe ngamabhizinisi, nokuphendula ezinkingeni zamabhizinisi ekuqinisekisweni kwemikhiqizo esikhathini esingamahora angama-24. Ekuqaleni kokugqashuka kobhubhane, iCentre for Instrumental Review yaphothula ukubuyekezwa kwezindawo ezine zokuhlola i-nucleic acid zamabhizinisi amane ngezinsuku ezine, kwathi ngokuhamba kwesikhathi, ngokuhambisana nesimo sokulwa nobhubhane, iSikhungo saphothula ngokwesayensi nangempumelelo. ukubuyekezwa okuphuthumayo kwama-reagents okuhlola ama-antigen, imishini yasekhaya ye-ECMO neminye imikhiqizo, okubambe iqhaza elihle ekunciphiseni ukushoda kwemishini yezokwelapha elwa nobhubhane. Ngokwezibalo, ngasekupheleni kuka-2023, ngaphezu kwe-150 ama-reagents amasha okutholwa kwe-coronavirus, kanye nezinsimbi ezihlobene nama-30, isoftware kanye nezingubo zokugqoka zagunyazwa ukumakethwa, okubandakanya imishini yokuhlanza igazi, ama-ventilators, imishini ye-ECMO nezinye izinto eziyisisekelo zokusekela. yahlangabezana ngempumelelo nezidingo zokuvimbela nokulawula ubhubhane.
Isikhathi sokuthumela: May-23-2024