Kuyambira pa 18 CPC National Congress, Komiti Yaikulu ya CPC yokhala ndi Comrade Xi Jinping pachimake idalimbikira kuyika thanzi la anthu pachitukuko, ndipo yapangitsa chitetezo chaumoyo wa anthu kukhala cholinga chofunikira kwambiri pakumenyera ufulu kwa chipani cha anthu. , zomwe zasonyeza bwino lomwe maganizo a chitukuko okhudza anthu. Kuwunika kwaukadaulo kwa zida zamankhwala kumatsatira zomwe Mlembi Wamkulu Xi Jinping adawonetsa pomanga China yathanzi komanso mzimu wa malangizo ofunikira pakuyang'anira mankhwala, amatsatira anthu, kuteteza ndi kupititsa patsogolo thanzi la anthu apachiyambi. Cholinga, ndi "zofunikira zinayi zolimba" monga chiwongolero chofunikira, kukulitsa kukonzanso, ndikukulitsa kukwezedwa kwa ntchito yonse kwapeza zotsatira zabwino. Ntchitoyi yapindula kwambiri.
Kwa zaka zambiri, Bungwe la State Drug Administration Medical Device Technical Review Center (lomwe limadziwika kuti Center) potsatira chitukuko chopangidwa ndi zatsopano, kumanga ndi kukonza dongosolo kuti lilimbikitse zatsopano; kulimbikitsa kutera kwa ntchito zazikulu za dziko, kuyang'ana kuthetsa vuto la "khosi"; kukwaniritsidwa kwasayansi ndi koyenera kwa kuyankha mwadzidzidzi pakuwunikanso, kuwonetsetsa kuti korona watsopano wa kupewa ndi kuwongolera mliri, ndi zina zambiri, akwaniritse zoyeserera zingapo, mitundu yayikulu yamitundu yosiyanasiyana ya kukhazikitsa "kulowererapo koyambirira, ndondomeko yabizinesi, njira yonse yowongolera, kufufuza ndi kuwunikiranso kulumikizana ", kulimbikitsa makampani opanga mankhwala, kudalirika kwasayansi ndiukadaulo komanso kudzidalira, kuti akwaniritse bwino anthu omwe ali ndi mwayi wopeza zida zatsopano komanso zotsika mtengo, komanso kuteteza bwino ufulu ndi zofuna za umoyo wa anthu onse.
Tsatirani ku drive innovation
Kuthandizira kupititsa patsogolo mpikisano wamakampani
Lipoti la 20th CPC National Congress likugogomezera kuti tiyenera kuumirira pazatsopano monga mphamvu yoyamba yoyendetsa galimoto, kugwiritsira ntchito mozama njira yachitukuko yoyendetsedwa ndi zatsopano, kutsegula minda yatsopano ndi njira zatsopano zachitukuko, ndikupitiriza kuumba mphamvu zatsopano ndi ubwino watsopano; imathandizira kukwaniritsidwa kwa sayansi ndiukadaulo wapamwamba wodzidalira komanso kudzidalira, komanso kutengera zofuna zadziko, kusonkhanitsa mphamvu kuti achite kafukufuku ndi chitukuko cha sayansi ndiukadaulo, motsimikiza kupambana nkhondo yaukadaulo wapamwamba kwambiri. , ndikufulumizitsa kukhazikitsidwa kwa ma projekiti angapo anzeru padziko lonse lapansi ndi omwe akuyembekezera zam'tsogolo padziko lonse lapansi zasayansi ndiukadaulo, komanso kukhazikitsa mndandanda wama projekiti anzeru komanso atsatanetsatane asayansi ndiukadaulo. Tidzafulumizitsa kukhazikitsidwa kwa mapulojekiti angapo akuluakulu a dziko lonse asayansi ndi luso lamakono okhala ndi zofunikira komanso zofunikira zapadziko lonse lapansi, ndikupititsa patsogolo luso lodzipangira okha.
Lipoti la 20th CPC National Congress lafotokoza njira zothandiza zolimbikitsira zatsopano za zida zamankhwala pansi pamikhalidwe yatsopanoyi. M'zaka zaposachedwapa, kwa China mankhwala chipangizo sayansi ndi luso thandizo luso akadali ofooka, khalidwe la mankhwala kutchulidwa ndi mlingo wapadziko lonse patsogolo kusiyana pakati pa zinthu zenizeni, zipangizo zachipatala kulimbikitsa luso kulimbikitsa kukonzanso mafakitale ndi luso lamakono, kusintha mafakitale. kupikisana monga cholinga, kuwonetsa malingaliro apamwamba apadziko lonse lapansi aukadaulo ndi kuyang'anira, kukonzekera kwanthawi yayitali ndikukhazikitsa pang'onopang'ono kwatsopano ndi chitukuko cha kusanthula ndi kafukufuku, kusintha zakuchita bwino pofuna kutsimikizira zosoweka za ntchito yomanga ndi kugwirira ntchito kwa njira zatsopano zatsopano ndi zina, ndikukwaniritsa mapulojekiti akuluakulu adziko lonse anzeru komanso amtsogolo kuti apititse patsogolo luso lodzipangira okha. Kukonzekera kwanthawi yayitali ndikukhazikitsa pang'onopang'ono zoyeserera monga kusanthula ndikuwunika momwe zinthu ziliri pakupanga zatsopano, kutsimikizira kufunikira kwa kusintha kwa zinthu zatsopano, komanso kupanga ndikugwiritsa ntchito njira zotsogola zatsopano zapeza zotsatira zabwino kwambiri.
Kulimbikitsa ndandanda wachangu wa zida zachipatala zatsopano
Mu 2014 ndi 2017, akuluakulu oyang'anira zachipatala motsatizana adakhazikitsa njira yapadera yowunikira zida zamakono komanso njira zovomerezera zida zamankhwala. Chiyambireni kukhazikitsidwa kwa njira ziwirizi, Center yakhala ikuchita mowona mtima zofunikira za Special Review Procedure for Innovative Medical Devices ndi Preority Approval Procedure for Medical Devices, kukhazikitsa Innovative Review Office ndi Priority Audit Office, ndi kukonza ndondomeko yowunikiranso. ndikumanga dongosolo la njira yowunikira mwachangu pazida zamankhwala zokhala ndi zatsopano, zapamwamba komanso zofunikira zachipatala mwachangu, kuti zilimbikitse kulowa kwazinthu zatsopano komanso zachipatala mwachangu. zida zofunikira zachipatala munjira yowunikira mwachangu. Pofika kumapeto kwa chaka cha 2023, zida 251 zatsopano zamankhwala ndi zida 138 zotsogola zidatsatiridwa mwachangu pamsika kudzera munjira yobiriwira, kuphatikiza zida zaukadaulo, zaukadaulo wapamwamba komanso zida zachipatala zachangu monga carbon ion therapy system, proton. dongosolo lamankhwala, mtima wochita kupanga, loboti yopangira opaleshoni, extracorporeal membrane oxygenation (ECMO), ndi zina zambiri, zomwe zimadzaza bwino mipata m'magawo oyenera, ndi kukhutitsa bwino kufunikira kwa anthu kugwiritsa ntchito zida zachipatala zapamwamba. Izi zadzaza bwino mipata m'magawo ofunikira ndikukwaniritsa zosowa za anthu pazida zapamwamba zachipatala.
Monga dipatimenti yayikulu yowunikira zida zachipatala zowunikira komanso kuunikanso zofunikira pazida zamankhwala, Center idakonza ndikuwongolera pang'onopang'ono machitidwe amkati mwazinthu ziwirizi, zomwe zimaphatikizapo kuyenga zowunikiranso, kuwunikira njira zogwirira ntchito, ndikugwirizanitsa mfundo zachitetezo chamankhwala. kulandira malingaliro, ndi zina zotero. Panthawi imodzimodziyo, Center yatulutsa "Special Innovative Medical Device Review" ndi "Special Innovative Medical Device Review". Panthawi imodzimodziyo, Center yapereka "Malangizo Okonzekera Chidziwitso cha Declaration for Special Review of Innovative Medical Devices", yomwe imamveketsa bwino zofunikira pokonzekera ndi kulemba chidziwitso cha chilengezo chogwiritsa ntchito zipangizo zamakono zamakono, ndikupereka malangizo enieni. kwa ofunsira komanso ogwira ntchito ku R&D. Pofuna kuonetsetsa kuti njira zogwirira ntchito zikuyenda bwino, Center yakhazikitsanso njira zoyankhulirana zopangira zida zachipatala zatsopano komanso zofunika kwambiri, ndikukhazikitsa njira yolumikizirana pa intaneti kuti ilimbikitse kukhazikitsidwa bwino komanso mwadongosolo kwa ntchito zofananira.
Kuwonetsetsa kuti kuwunika kwasayansi ndi chilungamo ndikuwunika Kuwonetsetsa kuti ntchito yowunikira zinthu zatsopano ndi kuwunikiranso koyambirira, bungwe la Instrument Review Center lakhazikitsa njira yolumikizirana ndi yowunikira, motsogozedwa ndi utsogoleri woyang'anira malo, Ofesi Yowunikira Zatsopano ndi Kuwunika Kwambiri. Office kukhazikitsa. Mamembala a maofesi awiriwa ndi State Drug Administration Division of Medical Device Registration, Instrumentation Review Center, Chinese Biomedical Engineering Society, Chinese Society for Biomaterials ogwira nawo ntchito, mwa mawonekedwe a mamembala a ntchitoyo adzakonzedwa mwa mawonekedwe a kuwunika ndi kuwunika misonkhano, kuunikanso kwa akatswiri pamalingaliro ndi nkhani zokhudzana ndi kafukufuku wamagulu onse ndi kupanga zisankho.
Kugwiritsa ntchito moyenera komanso mwasayansi kwa akatswiri akunja kumathandiza kupititsa patsogolo ntchito yabwino yowunikiranso zatsopano komanso kuunikanso koyambirira. Gulu la akatswiri pakuwunika kwaukadaulo kwa zida zamankhwala lidakhazikitsidwa mwalamulo mu Marichi 2017, ndipo Center for Instrumental Review yakhazikitsa njira yothandizira oyang'anira akatswiri akunja kuti akhazikitse mapangidwe, kusankha, kugwira ntchito tsiku ndi tsiku ndi ntchito zina za akatswiri owunikira. dziwe. Pankhani yogwira ntchito ya msonkhano wokambirana ndi akatswiri, lafufuza za kukhazikitsa njira yosankha mwachisawawa kwa akatswiri, kuwongolera mawonekedwe a msonkhano wokambirana ndi akatswiri, kupeŵa kulowererapo kwa anthu pakuwunikanso akatswiri kwambiri, ndikutsimikizira chilungamo, kupanda tsankho ndi mphamvu zasayansi za ntchito yowunikira. Pakadali pano, dziwe la akatswiri likuyang'aniridwa mwamphamvu, ndipo kwenikweni, limagawidwa ndikugwiritsa ntchito kwachipatala kwa zida zachipatala za Gulu lachitatu, ndipo makomiti alangizi a akatswiri 17 akhazikitsidwa, ndipo kusankha magulu 5 a akatswiri akunja kwatha. , okhala ndi akatswiri akunja okwana 2,374 (kuphatikiza akatswiri 41), kuphatikiza akatswiri 119 ndi mayendedwe 244 ofufuza.
Kupititsa patsogolo Kuwunikiridwa kwa Zinthu Zotsogola Zazachipatala zokhala ndi ufulu wodziyimira pawokha, pamlingo wotsogola wapadziko lonse lapansi, zokhala ndi mtengo wofunikira wachipatala, ndi zida zamankhwala zomwe zikufunika mwachangu, mothandizidwa ndi mapulojekiti apadera adziko lonse ndi mapulogalamu akuluakulu a R&D, Center yapitilizabe kuwunikiranso zowunikira molingana ndi mfundo yosatsitsa miyezo ndikupititsa patsogolo ntchito. Center ikupitilizabe kukhathamiritsa kuwunika kwaukadaulo kwazinthu zotsogola, ndipo imayang'ana kwambiri zachipatala, kuyang'ana owunikira akuluakulu ochokera m'madipatimenti osiyanasiyana owunikira kuti apange gulu loti liwunikenso pamodzi, ndi malingaliro owunikira bwino omwe amaperekedwa ndi azachipatala, uinjiniya ndi magulu ena akatswiri. Pakuwunikanso, owunikira amatumizidwa kuti akatenge nawo gawo pakutsimikizira kasamalidwe kaubwino wolembetsa powunikiranso pamasamba, kuti amvetsetse bwino komanso momveka bwino zinthu zatsopano komanso zotsogola ndikuyika patsogolo malingaliro asayansi ndi omveka bwino. Kuphatikiza apo, imaphatikizanso njira yoyang'anira mu kasamalidwe ka projekiti ndi kawongolero kabwino kuti muzindikire kufupikitsa koyenera kwa nthawi yowunikira zinthu poyerekeza ndi nthawi yowunikiranso yovomerezeka.
Kulimbikitsa Kusintha kwa Zochita Zatsopano Zomwe Zimayendetsedwa ndi Zosowa Zachipatala
Kuunika kwachipatala ndichinthu chofunikira kwambiri pakuwongolera zida zachipatala zatsopano. M'zaka zaposachedwa, Center wagwira ntchito zingapo m'munda wa kuwunika kwachipatala kwa zida zamankhwala, pang'onopang'ono kulinganiza lingaliro lowunikira, zofunikira ndi dongosolo la kuwunika kwachipatala kwa zida zamankhwala, kukulitsa ndikukulitsa magwero a data yachipatala, kuthetseratu ambiri. nkhani zazikulu monga momwe angachitire mayesero azachipatala, ndikupanga njira zatsopano ndi zida zowunikira zachipatala, ndipo adapanga lingaliro lasayansi lowunika zachipatala. Pakuwunikanso zinthu zinazake, njira yowunikira zinthu zosiyanasiyana zachipatala yafika pa mgwirizano m'mabungwe owongolera ndi mafakitale, ndipo kuchuluka kwa mayesero azachipatala pakulembetsa kwazinthu ndi ma projekiti osintha malayisensi ali pamlingo woyenera.
Kupanga njira yokhazikika yowunikiranso zaukadaulo pakuwunika kwachipatala M'zaka zaposachedwa, Center idapanga zikalata zolumikizana padziko lonse lapansi kuti ziwunikire zachipatala ndikuzisinthanso kukhala zolemba zaku China, ndikupanga mfundo 8 zotsogola ndi njira 22 zoyezetsa zachipatala, zomwe zimafotokoza momveka bwino. zinthu zofunika kwambiri pazachipatala. Pakadali pano, njira yowunikiranso zaukadaulo yamagulu atatu yakhazikitsidwa ndi "Mfundo zazikuluzikulu zowunikira zachipatala - mfundo zowongolera pakuwunika kwamankhwala amitundu yosiyanasiyana yazinthu - mfundo zazikuluzikulu zowunikiranso zaukadaulo pakuwunika kwamankhwala amitundu yosiyanasiyana" . Pakalipano, pamaziko a mfundo zotsogola, zopitilira 70 zowunikira zamitundu yosiyanasiyana yazamankhwala komanso mfundo zazikulu zopitilira 400 zowunikiranso zaukadaulo pakuwunika kwachipatala zidapangidwa, ndikuzindikira kufalikira kwazinthu zonse ziyenera kuwunikiridwa mwachipatala pansi pa mndandanda wa magawo atatu a Classification Catalogue of Medical Devices, ndikukwaniritsa kuwunika kwachipatala. zida zokhala ndi kuchuluka kwazinthu zomveka bwino, njira yowunikira bwino komanso zofunikira zowunikira, zomwe zimapereka zitsogozo zoyambira pakuyesa kwachipatala kwa zida zachipatala zatsopano. Limapereka chitsogozo chofunikira pazida zamakono zochitira mayeso azachipatala.
Kupititsa patsogolo kupezeka kwa zinthu zatsopano Kupititsa patsogolo kupezeka kwa zinthu zatsopano zomwe zimagwiritsidwa ntchito pachipatala ndi njira yofunika kwambiri yopezera chithandizo cha odwala omwe ali ndi matenda oopsa kwambiri. Center yapitilizabe kulabadira zinthu zofunika kwambiri m'derali ndipo yapereka njira zoyenera zogwirira ntchito. Mwachitsanzo, Center idachita kafukufuku wokhudzana ndi kuvomereza kovomerezeka kwa zida zamankhwala, kuwunika mozama kuopsa ndi maubwino azinthuzo, ndikuwongolera zofunikira kuti zivomerezedwe mwapang'onopang'ono, ndikulimbikitsa kuvomereza kovomerezeka kwa zida zamankhwala zomwe zimagwiritsidwa ntchito pochiza matenda oopsa. ndipo palibe chithandizo chothandiza chomwe chikupezeka posachedwa; yachitanso kafukufuku wokhudzana ndi kukula kwa kugwiritsa ntchito zipangizo zachipatala muzochitika zachipatala, kulongosola zofunikira kuti awonjezere mayesero achipatala, ndikulimbikitsanso kugwiritsa ntchito zipangizo zamankhwala zomwe zimagwiritsidwa ntchito pochiza matenda aakulu omwe alipo. palibe mankhwala othandiza. Kulimbikitsa kugwiritsa ntchito zida zamankhwala pochiza matenda oopsa omwe alibe njira zochiritsira, komanso kukwaniritsa zofunikira za odwala omwe akufunika chithandizo chamankhwala mpaka momwe angathere ndikutsimikizira chitetezo chogwiritsidwa ntchito ndi anthu. zida zamankhwala; kuti tipitirire patsogolo ntchito yoyendetsa ndege yogwiritsira ntchito deta yeniyeni ku Boao Lecheng, kupanga njira zowunikira zachipatala, ndi kufufuza mwakhama njira yogwiritsira ntchito deta yeniyeni polembetsa katundu. Poyankha zomwe zili pamwambazi, yapanga motsatizana Mfundo Zotsogolera Zovomerezeka Zovomerezeka za Zida Zachipatala Zolemba, Technical Guiding Principles for Clinical Evaluation of Real-World Data for Medical Devices (for Trial Implementation), ndikuchita nawo ntchito yopanga Zida Zachipatala
Limirirani kuyesetsa kwambiri
Ganizirani za kuthetsa vuto la "khosi".
Mlembi Wamkulu Xi Jinping amawona kufunikira kwakukulu kwa matekinoloje ofunikira. Anagogomezera kuti tiyenera kuyang'ana pa kafukufuku wofunikira kwambiri waukadaulo, kufulumizitsa njira yothetsera mankhwala angapo, zida zamankhwala, zida zamankhwala, katemera ndi madera ena a vuto la "khosi"; kufulumizitsa kupanga kwa gulu lalifupi la zida zachipatala zaku China zapamwamba, kufulumizitsa kafukufuku wofunikira pachimake chaukadaulo, zopambana pazida zaukadaulo izi, ndikuzindikira zida zachipatala zodziyimira pawokha komanso zowongolera; kulimbikitsa kafukufuku wofunikira komanso luso lopanga luso la sayansi ndiukadaulo, ndikuyika moyo wa chitukuko chamakampani azachipatala m'manja mwathu. Kafukufuku woyambira komanso luso lopanga luso la sayansi ndi ukadaulo, zomwe zimadzetsa chitukuko chamakampani azachipatala mwamphamvu m'manja mwathu.
Kuti athetse vuto la "khosi" pazida zamankhwala, kuwunika kwaukadaulo kwa zida zamankhwala kwapeza mfundo zitatu zofunika, poyang'ana kuphatikizika kwazinthu zatsopano, zatsopano munjira yogwirira ntchito, zopambana pazofunikira kuti ayambe kufufuza ndikuyika. kupititsa patsogolo njira zogwiritsiridwa ntchito. Kuphatikizika kwa zinthu zatsopano, kutengera kusonkhanitsa kwazinthu zowunikira, boma logwirizana, mafakitale, maphunziro, kafukufuku ndi kugwiritsa ntchito maphwando onse, pankhani yanzeru zopangapanga ndi biomaterials kuti apange kutseguka ndi kugawana zatsopano ndi mgwirizano; mu luso lachitsanzo ntchito, kafukufuku, kulimbikitsa kubwereza kwa likulu mphamvu yokoka pang'onopang'ono kwa siteji chitukuko mankhwala, kukhazikitsa chipangizo chachipatala chisanadze kuunikanso; pakupambana kwazinthu zazikuluzikulu, nkhope ya omwe adathamanga kuti apange zida zakuchipatala zaku China zapamwamba zaku China zomwe zachitika mwachangu. Pankhani yodutsa zinthu zazikuluzikulu, poyang'anizana ndi vuto lofulumira kuti apange gulu lalifupi la zida zachipatala zapamwamba ku China, kafukufuku wozama ndi kuthandizira zida zachipatala zapamwamba zapakhomo zachitika, ndipo zotsatira zina zapezeka.
Kumanga Pulatifomu Yotseguka ndi Yogawana Zatsopano ndi Mgwirizano
Kuti timvetsetse njira yoyambira kusintha kwatsopano kwa sayansi ndiukadaulo ndikuyang'ana kwambiri mbali zazikuluzikulu zolimbikitsira mindandanda yazida zodziwika bwino zapakhomo, Center yakhazikitsa njira yotseguka komanso yothandizana ndi zida zamankhwala pazanzeru zopanga. ndi biomaterials pamaziko a kusanthula ndi kuweruza mkhalidwe chitukuko cha munda mankhwala mankhwala China, kuyesetsa kukhazikitsa luso ndi mgwirizano nsanja. kuyang'anira sayansi pazida zamankhwala, luso la sayansi ndi luso laukadaulo, ndikusintha kwazinthu kuti apange nsanja yaukadaulo wasayansi ndiukadaulo, kusintha kopambana, kuyang'anira boma, ndikusintha kwazinthu. Amayesetsa kumanga nsanja yogwirizana kuti ikhale yoyang'anira sayansi yazida zamankhwala, sayansi ndi ukadaulo waukadaulo komanso kusintha kwazinthu, ndikupanga njira yabwino yolumikizirana yaukadaulo wasayansi ndiukadaulo, kusintha kopambana, kuyang'anira boma komanso kudziletsa pamakampani.
Chiyambireni kukhazikitsidwa ndikugwira ntchito mu Julayi 2019, Artificial Intelligence Medical Device Innovation Cooperation Platform yamanga bwino zida zachipatala zaku China za Artificial Intelligence, njira zoyesera ndi machitidwe ena ofananira nawo, ndi malangizo ofunikira monga "Mfundo Zofunikira Zowunikira Maphunziro Ozama- Mapulogalamu Othandizira Opanga zisankho pazida Zachipatala", "Mfundo Zofunikira Zowunikiranso Kujambula kwa Pneumonia CT Kuthandizidwa Diagnostic and Evaluation Software (Trial)”, ndi “Guidelines for the Registration Review of Artificial Intelligence Medical Devices” apangidwa ndikutulutsidwa motsatizana. Mfundo zakhazikitsidwa ndikumasulidwa chimodzi pambuyo pa chimzake, ndikupereka chitsimikizo chofunikira chofunikira pakukula kwa mafakitale a zida zachipatala za AI. Komanso, nsanja nayenso bwinobwino anamanga Nawonso achichepere choyambirira mayesero kuphimba ambiri matenda madera monga fundus ultrasound kwa matenda a shuga retinopathy, CT chibayo, chithokomiro ultrasound, etc. Databases monga khomo lachiberekero zithunzi cytopathic ndi multimodal zithunzi za matenda myopia akumangidwa, kupereka njira yosonkhanitsira, kuyang'anira, ndi kugwiritsa ntchito deta kuti zinthu za AI ziphatikizidwe ndikugawidwa.
Kuyambira pomwe idakhazikitsidwa mu Epulo 2021, Biomaterials Innovation Cooperation Platform yatenga nawo gawo popanga mfundo zotsogola, mfundo zowunikira komanso malangizo aukadaulo okhudza magawo osiyanasiyana monga ma in vitro diagnostic reagents ndi zida, zopangira zowonjezera, zida za ECMO ndi zida zodzikongoletsera zamankhwala, zomwe zalimbikitsa kusintha ndi kugwiritsa ntchito zopambana zasayansi ndi ukadaulo m'munda wa biomaterials ndi matekinoloje ofunikira mu gawo la zida zamankhwala. Ndi chithandizo cha pulatifomu, kupititsa patsogolo kwapangidwe kwakhala kukuchitika m'malo opangira zinthu zomwe zimadalira kunja monga polyether ether ketone materials (PEEK) kwa implants; China ikupitilizabe kutsogolera m'mabwalo apadziko lonse pazamankhwala opindulitsa, monga sodium hyaluronate …… gulu lotsogola lazinthu zatsopano likupitilira kuwonjezeka.
Onani kukhazikitsidwa kwa njira yowunikiranso ntchito
Pamaziko a kufotokoza mwachidule ndi kusanthula mphamvu ya kusintha kwa kuwunika kwa chipangizo chachipatala ndi kuvomereza dongosolo, Center for Instrumental Review inasonyeza chitsanzo chapamwamba chapadziko lonse lapansi, ndipo pang'onopang'ono inapanga malingaliro atsopano owunikira ntchito, ndikufufuza mwakhama mbali yazinthu zowunikira. mpaka kumapeto kwa chitukuko cha mankhwala akupita patsogolo kwa chitsanzo cha ntchito. M'mbuyomu, kutumizidwa kwa makonzedwe aukadaulo waukadaulo wa zida zamankhwala ndikuwunikanso malo apakati a Yangtze River Delta ndi Bay Area District Center yodzipereka kuti itsogolere kayendetsedwe ka kafukufuku ndi chitukuko, kafukufuku wakuya ndi kuwunika. za zofunikira zapakhomo zapamwamba, zodzipangira zokha kuti zitheke kulowererapo koyambirira kwa woyendetsa chitukuko cha zinthu, komanso kulumikizidwa ndi kafukufuku wa kuwunika kwapakati pa mphamvu yokoka. za kupititsa patsogolo kukhazikitsidwa kwa njira yeniyeni, njira zowunikira zoyeserera, njira zoyendetsera polojekiti yodzipereka ndi zina zambiri. 2022 Mu 2022, boma lidzakhazikitsanso kuwunika kwa zida zachipatala, ndikutulutsa "Code of Practice for Review of Key Projects and Key Products for the Technical Review of Medical Devices (poyesa Kuyesa)", kuwonetsa ntchito zazikulu ndi zamankhwala. zida zokhala ndi matekinoloje ofunikira kwambiri komanso mtengo wofunikira wachipatala, ndikulimbikitsa kuwunikiridwanso kwa kulowererapo koyambirira pakufufuza kwatsopano ndi kupanga zinthu pogwiritsa ntchito kulowererapo koyambirira, chimodzi bizinesi, ndondomeko imodzi, chiwongolero chonse cha ndondomeko, ndi kufufuza ndi kuwunikira.
Kuthandizira kafukufuku ndi chitukuko cha zipangizo zachipatala zapamwamba zapakhomo
Zida zachipatala zaku China zapamwamba zimakhalapo m'mbali mwazolepheretsa, makina onse opanga makina ndi otsika komanso zovuta zina. Kuti athetse mavuto omwe ali pamwambawa, Center imayang'ana kwambiri zofunikira zadziko zoganiza zogwira ntchito, kukonzekera mwachangu, kudziwa bwino zamakampani ndi chitukuko cha sayansi ndiukadaulo, ndikudziunjikira nthawi zonse njira zazikulu ndi nkhokwe zaukadaulo, kuchirikiza chinsinsi chachikulu. kafukufuku wamakono ndi chitukuko, kufulumizitsa kukwaniritsidwa kwa ndondomeko ya kukhazikitsidwa kwa zipangizo zamakono zachipatala, ndikufulumizitsa kupanga gulu lalifupi la zida zachipatala zapamwamba. Tidzachita kafukufuku wozama pa zomwe zikuchitika masiku ano "chotsekeka" cha zipangizo zamankhwala zopangira (zigawo), kuonjezera chithandizo cha zipangizo zamankhwala zapamwamba zomwe zili ndi zigawo zikuluzikulu zomwe zimapangidwira monga ECMO, madzi opanda helium magnetic resonance, etc., ndikuchita kafukufuku wamitundu yosiyanasiyana komanso kulumikizana mwachangu. 2022, njira yoyamba yopangira mankhwala a proton, zida zamankhwala zoyamba zoyikika zokhala ndi ukadaulo wa maginito wamadzimadzi, komanso zida zamankhwala zoyambira zokhala ndi ukadaulo wa maginito-liquid levitation zidzapangidwa pamsika wapanyumba. makina othandizira kumanzere kwa ventricular pogwiritsa ntchito ukadaulo wamaginito kuyimitsidwa kwamadzi adzavomerezedwa ndikugulitsidwa, ndipo makina opangira kaboni ion therapy adzakhala atamaliza kusintha kwake ndikukweza; mu 2023, zinthu zitatu zopangidwa m'nyumba za ECMO zidavomerezedwa ndikugulitsidwa, ndipo vuto la matabwa afupiafupi a zida zamankhwala zapamwamba ku China lidzathetsedwa mokhazikika komanso mogwira mtima.
Kumamatira kwa Anthu Choyamba
Kuyesetsa kwapang'onopang'ono kuteteza ndi kuteteza miliri
Mu Disembala 2019, mliri watsopano wadzidzidzi unawopseza kwambiri miyoyo ndi chitetezo chaumoyo wa anthu. Mlembi wamkulu Xi Jinping adapereka malangizo ofunikira popewa komanso kuwongolera mliriwu. Pansi pa utsogoleri wamphamvu wa gulu la chipani cha State Drug Administration, kuunikanso kwaukadaulo kwa zida zamankhwala, motsogozedwa ndi lingaliro la Xi Jinping la socialism yokhala ndi mawonekedwe achi China m'nthawi yatsopano, adakwaniritsa mosamala zofunikira za "zinayi zolimba kwambiri", zotsatiridwa. mfundo yoyika chitetezo cha moyo ndi thanzi la anthu poyambirira, molingana ndi "lamulo logwirizana, kuchitapo kanthu mwamsanga, kuvomerezedwa ndi sayansi", ndi "zinayi zokhwima" Zofunikira, Mogwirizana ndi mfundo za "lamulo logwirizana, kulowererapo koyambirira, kuwunikiranso pa malo ndi kuvomereza kwasayansi" komanso zofunikira pakuwonetsetsa kuti zinthu zili zotetezeka, zogwira mtima komanso zowongolera, tamaliza ntchito yowunikira mwadzidzidzi ndiukadaulo wapamwamba, womwe wapereka. chitsimikizo chothandiza kupewa ndi kuwongolera mliri.
Kutulutsidwa kwa mfundo zowunikira mwadzidzidzi
Mliriwu utabuka, State Drug Administration (SDA) idayambitsa njira yovomerezera zida zachipatala nthawi yoyamba, ndikutsimikiza kuchuluka kwazinthu zomwe zikuyenera kuphatikizidwa muzovomerezeka zadzidzidzi. Pofuna kuthandizira opanga kupanga zida zatsopano zowunikira ma coronavirus kuti apewe ndi kuwongolera miliri posachedwa ndikulembetsa bwino pamsika, ndikofunikira kwambiri kutulutsa zikalata zowongolera panthawi yake kuti zitsogolere chitukuko ndi kulembetsa kwazinthu. Pamaziko a kutolera zolemba zoyenera ndikupempha malingaliro a akatswiri, Center for Instrumental Review (CIR) idafufuza ndikukonza ndikutulutsa padziko lonse lapansi "Mfundo Zofunikira pakuwunika kwaukadaulo pakulembetsa kwa 2019 Novel Coronavirus Nucleic Acid Detection Reagents" ndi "Key. Mfundo Zowunikira Zaukadaulo Zakulembetsa kwa Novel Coronavirus Antigen / Antibody Detection Reagents mu 2019 ”, zomwe cholinga chake ndi kupereka chitsogozo kwa omwe adzalembetse ntchito pokonzekera zidziwitso, kuwonetsetsa kuwunikanso, ndikufulumizitsa kuvomerezedwa kwa zida zatsopano zoyezera coronavirus kuti zigwiritsidwe ntchito popewa komanso kuwongolera mliri. Ma reagents atsopano a coronavirus pamsika amapereka maziko aukadaulo. Panthawi ya mliriwu, Maupangiri Owunikira Kulembetsa kwa New Coronavirus (2019-nCoV) Antigen Detection Reagents, Malangizo Owunikanso Pneumonia CT Imaging Assisted Diagnosis and Evaluation Software (Trial), Malangizo Owunikira Zida Za Extracorporeal Membrane Lung Oxygenation (ECMO) , ndi zolemba zina zofunika zotsogola zapangidwa ndikumasulidwa malinga ndi momwe zinthu zilili za anti-epidemic, zomwe zimapereka malangizo othandiza pakuwunika kwaukadaulo komanso kafukufuku ndi chitukuko cha zinthu zamabizinesi.
Kuchita ndemanga zadzidzidzi
Pitirizani kulamula ndikunyamula katundu wolemetsa. Boma la State Drug Administration litakhazikitsa njira yovomerezera mwadzidzidzi, Center for Instrumental Review (CIRC) yakhala ikukhazikitsa mwachangu ntchito yowunikira mwadzidzidzi, kuwonetsa mawonekedwe asayansi ndi magwiridwe antchito apamwamba, ndikuwongolera mosamalitsa mtundu wazinthu. Kupyolera mu sayansi yomanga chitetezo cha mankhwala ndi chitsanzo chowunikira bwino, timapanga chigamulo cholondola pazofunikira zazinthu zatsopano zosiyanasiyana, kulankhulana bwino ndi kuyendera, kuwunika kwadongosolo ndikuwunikanso nkhani zapatatu, ndikulimbikitsana mwachidwi kuwunika kwadzidzidzi. Specific modus operandi ya Emergency Review Working Group imaphatikizapo kulowererapo pa chitukuko cha mankhwala pasadakhale, kuyankhulana mwachindunji ndi gulu la R & D, kumvetsetsa momwe zinthu zilili pa R & D, ndi kutsogolera njira zopangira mankhwala ndi chitukuko; kuwunika kwanthawi yake kwazinthu zomwe ziyenera kulengezedwa, ndikuwatsogolera olembetsa kuti achite ntchito yolengezetsa kulembetsa koyamba; kuwunika pafupipafupi zomwe zaperekedwa ndi mabizinesi, ndikuyankha zovuta zamabizinesi pakutsimikiza kwazinthuzo mu nthawi ya maola 24. Kumayambiriro kwa mliriwu, Center for Instrumental Review idamaliza kuwunikanso ma reagents anayi oyesa ma nucleic acid amakampani anayi m'masiku anayi, ndipo pambuyo pake, mogwirizana ndi zomwe zidachitika polimbana ndi mliri, Center idamalizidwa mwasayansi komanso moyenera. kuwunika kwadzidzidzi kwa ma reagents oyesa ma antigen, zida zapakhomo za ECMO ndi zinthu zina, zomwe zidathandizira kuchepetsa kuchepa kwa zida zachipatala zolimbana ndi mliri. Malinga ndi ziwerengero, pofika kumapeto kwa 2023, zida zopitilira 150 zozindikira ma coronavirus, ndi zida zopitilira 30, mapulogalamu ndi zovala zidavomerezedwa kuti zigulitsidwe, kuphatikiza zida zoyeretsera magazi, ma ventilator, zida za ECMO ndi zida zina zofunika, zomwe. adakwaniritsa zofunikira za kupewa ndi kuwongolera mliri.
Nthawi yotumiza: May-23-2024