Kubva paCPC National Congress yechigumi nesere, CPC Central Committee naComrade Xi Jinping pahwaro hwayo vakasimbirira kuisa hutano hwevanhu munzvimbo yepamberi yebudiriro, uye vakaita kuchengetedzwa kwehutano hwevanhu chinangwa chakakosha chekurwira vanhu kweBato. , iyo yakaratidza zvizere pfungwa yebudiriro inonangana nevanhu. Ongororo yehunyanzvi yemidziyo yekurapa inoteedzera kuratidzwa kwakakosha kweMunyori Mukuru Xi Jinping pakuvakwa kweChina ine hutano uye mweya wemirairo yakakosha pamusoro pekutarisa zvinodhaka, inonamatira kune vanhu-yakatarisana, kuchengetedza uye kukurudzira hutano hweveruzhinji hwepakutanga. mishoni, ine “zvina zvakanyanya kuomesesa” zvinodiwa segwara rakakosha, kudzamisa shanduko, uye kudzamisa kusimudzirwa kwebasa rose kwawana mhedzisiro inoshamisa. Basa racho rakawana migumisiro inoshamisa.
Kwemakore, iyo State Drug Administration Medical Device Technical Review Center (inozonzi Center) mukuomerera kune inofambiswa nekuvandudza, kuvaka nekuvandudza hurongwa kukurudzira hunyanzvi; kukurudzira kumhara kwemapurojekiti makuru enyika, kutarisa kugadzirisa dambudziko re "mutsipa"; kupedzisa kwesainzi uye nekubudirira kwekupindura kwechimbichimbi pakuongorora, kuve nechokwadi chekuti korona itsva yekudzivirira nekudzora denda, nezvimwewo kuita zvakatevedzana zvezvirongwa, zvakakosha zvakasiyana-siyana zveKuitwa kwe "kupindira kwekutanga, bhizinesi mutemo, hurongwa hwese hwekutungamira, kutsvagisa uye ongororo yekubatanidza”, kusimudzira indasitiri yemishonga, mwero wepamusoro wesainzi uye tekinoroji kuzvivimba uye kuzvimiririra, kusangana neveruzhinji nekuwana, uye kukwanisika kune nekukurumidza kudiwa kwetsva. zvombo, uye kuchengetedza zvinobudirira kodzero nezvido zveutano hweveruzhinji.
Batira kune innovation drive
Kubatsira kuvandudza kukwikwidza kweindasitiri
Chirevo che20th CPC National Congress chinosimbisa kuti tinofanira kuomerera pakuvandudza sesimba rekutanga rekutyaira, kushandisa zvakadzama chirongwa chekuvandudza chinofambiswa nehunyanzvi, kuvhura minda mitsva nemakwara matsva ebudiriro, uye kuramba tichigadzira nhanho itsva uye zvakanakira zvitsva; kukurumidzira kuzadzikiswa kwekuzvimiririra kwepamusoro-soro kwesainzi uye tekinoroji uye kuzvimiririra, uye inotungamirwa nezvinodiwa nenyika, unganidza masimba ekuita yekutanga uye inotungamira sainzi uye tekinoroji tsvagiridzo nekusimudzira, kuhwina zvakasimba muhondo yemakiyi etekinoroji. , uye kukurumidzira kuitwa kwehuwandu hwehurongwa hwepasirese uye hunotarisira mberi mapurojekiti makuru esainzi uye tekinoroji, pamwe nekuitwa kwenhevedzano yemapurojekiti esainzi uye tekinoroji. Tichakurumidzisa kuitwa kwemapurojekiti makuru enyika esainzi uye tekinoroji ane hunyanzvi uye kukosha kwepasirese, nekusimudzira kugona kwehunyanzvi hwakazvimirira.
Chirevo che20th CPC National Congress chakaratidza gwara rinoshanda rekukurudzira kuvandudzwa kwemidziyo yekurapa pasi pemamiriro matsva. Mumakore achangopfuura, kuChina mudziyo wezvokurapa sainzi uye tekinoroji tsigiro yekuvandudza ichiri kusimba, kunaka kwezvinhu zvakanyorwa uye yepasirese yepamusoro nhanho yepakati pakati pemamiriro chaiwo, zvigadzirwa zvekurapa kukurudzira hunyanzvi kusimudzira kugadziridzwa kwemaindasitiri uye hunyanzvi hwekuvandudza tekinoroji, kuvandudza maindasitiri. kukwikwidza sechinangwa, kuenzanisa pfungwa yepasirese yepamusoro yekuvandudza nekutarisa, kuronga kwenguva refu uye kuita zvishoma nezvishoma kwekuvandudza nekuvandudza mamiriro ekuongorora nekutsvaga, shanduko yezviwanikwa zvitsva kusimbisa zvinodiwa zvekuvandudza nzira yekuvaka nekushanda. uye zvimwe zvirongwa, uye zvakawana akati wandei ehurongwa uye anotarisisa mapurojekiti makuru enyika kusimudzira kugona kwakazvimirira kwekuvandudza. Kuronga kwenguva refu uye kuita zvishoma nezvishoma zvirongwa zvakaita sekuongorora uye kutonga mamiriro ekuvandudza hunyanzvi, kusimbisa kudiwa kweshanduko yebudiriro yeunyowani, nekuvaka nekushandisa nzira dzekutanga dzekutanga dzakawana mhedzisiro inoshamisa.
Kukurudzira kukurumidza kunyorwa kwezvishandiso zvekurapa zvitsva
Muna 2014 na2017, zviremera zvepasi rose zvinodzora zvinodhaka zvakatevedzana zvakagadzira nzira yakakosha yekuongorora yezvishandiso zvekurapa zvine hunyanzvi uye nzira yekubvumidza yekutanga yemidziyo yekurapa. Kubva pakavambwa machani maviri aya, Center yaita nemoyo wese zvinodikanwa zveSpecial Ongororo Procedure yeInnovative Medical Devices uye Yekutanga Kubvumidzwa Procedure yeMedhivha Devices, kumisikidza Innovative Ongororo Hofisi uye Yekutanga Audit Hofisi, uye yakakwenenzvera maitiro ekuongorora. uye kuvakwa kwehurongwa hwekukurumidza kudzokorora nzira yezvishandiso zvekurapa zvine hunyanzvi, nhanho yepamusoro uye nekukurumidzira zvinodiwa zvekiriniki, kuitira kusimudzira kupinda kwezvinhu zvitsva uye zvekiriniki zvinodiwa nekukurumidza muchiteshi chekuongorora nekukurumidza. Pakupera kwa2023, mazana maviri nemakumi mashanu neimwe michina yekurapa yemhando yepamusoro uye zana nemakumi matatu ane masere ekutanga ezvokurapa zvakange zvave kumhanyisa kumusika kuburikidza neyakasvibira chiteshi, kusanganisira nhevedzano yehunyanzvi, hwepamusoro-soro uye hunyanzvi hwekurapa hwekukurumidzira senge carbon ion therapy system, proton. therapy system, artificial heart, surgical robhoti, extracorporeal membrane oxygenation (ECMO), zvichingodaro, izvo zvinonyatsozadza maburi muminda yakakodzera, uye zviri nani kugutsa zvinodiwa nevanhu kushandisa michina yekurapa yepamusoro. Izvi zvakazadza mikaha mundima dzakakodzera uye zvakazadzisa zvirinani zvinodiwa nevanhu zvemichina yekurapa yepamusoro.
Sedhipatimendi repamusoro rekutsvagisa mudziyo wezvekurapa uye kuongororwa kwekutanga kwemidziyo yekurapa, iyo Center yakagadzira uye zvishoma nezvishoma yakagadziridza maitiro emukati ekushanda kwezvinhu zviviri izvi, izvo zvinonyanya zvinosanganisira kukwenenzvera zvinodikanwa zvekuongorora, kujekesa nzira dzekushanda, uye kubatanidza misimboti. kugamuchira maonero, nezvimwewo. Panguva imwecheteyo, Centre yakabudisa "Special Innovative Medical Device Review" uye "Special Innovative Medical Device Review". Panguva imwecheteyo, Center yakapa "Nhungamiro yeKugadzirira Kwekuzivisa Ruzivo rweKuongorora Kwakakosha kweInnovative Medical Devices", iyo inojekesa zvinodiwa pakugadzirira uye kunyorwa kweruzivo rwekuzivisa nezvekushandiswa kwezvishandiso zvekurapa zvitsva, uye inopa nhungamiro chaiyo. kune vanonyorera uye nevashandi veR&D. Kuti ive nechokwadi chekuitwa kwakanaka kwemaitiro ebasa, iyo Center yakamisawo nzira dzekutaurirana dzezvitsva uye zvekutanga zvigadzirwa zvemidziyo yekurapa, uye yakamisa chikuva chekubvunzana pamhepo kusimudzira kushanda uye kurongeka kwekuita basa rakabatana.
Iva nechokwadi chekuongorora nekuongorora kwesainzi uye kwakaringana Kuti ive nechokwadi chemhando yebasa rekuongorora hunyanzvi uye kuongororwa kwekutanga, Instrument Review Center yakagadzira ongororo yakabatana uye nzira yekuongorora, inotungamirwa nehutungamiriri hwepakati, Hofisi Yekuongorora Innovation uye Yekutanga Ongororo. Office kuita. Nhengo dzemahofisi maviri aya neState Drug Administration Division of Medical Device Registration, Instrumentation Review Center, Chinese Biomedical Engineering Society, Chinese Society for Biomaterials vashandi vakakodzera, muchimiro chenhengo dzebasa icharongwa nenzira ye misangano yekuongorora uye yekuongorora, kuongororwa kwenyanzvi kwemaonero uye zvine chekuita nenyaya dzekutsvagisa pamwe nekuita sarudzo.
Iko kushandiswa kunoshanda uye kwesainzi kwezviwanikwa zvehunyanzvi zvekunze kunobatsira kuwedzera kunaka kwebasa rekuongorora hunyanzvi uye kuongororwa kwekutanga. Dziva rehunyanzvi rekuongororwa kwehunyanzvi hwezvishandiso zvekurapa rakavhurwa zviri pamutemo muna Kurume 2017, uye Center for Instrumental Review yakagadzira hurongwa hwekutsigira manejimendi enyanzvi dzekunze kumisa kuumbwa, kusarudzwa, kushanda kwemazuva ese uye rimwe basa renyanzvi yekuongorora. dziva. Panyaya yekushanda kwemusangano wekubvunzurudza nyanzvi, yakaongorora kugadzwa kwechigadziro chekusarudza mapofu kune nyanzvi, yakavandudza chimiro chemusangano wekubvunza nyanzvi, yakadzivirira kupindira kwevanhu mukuongorora kwenyanzvi kusvika pamwero mukuru unobvira, uye yakavimbisa kururamisira, kusarerekera uye kushanda kwesainzi kwebasa rekuongorora. Parizvino, dziva renyanzvi riri pasi pehutongi hwesimba, uye musimboti, rakakamurwa nekushandiswa kwekiriniki kweClass III michina yekurapa, uye gumi nenomwe makomiti ekuraira enyanzvi akamiswa, uye kusarudzwa kwemapoka mashanu enyanzvi dzekunze kwapera. , nehwerengedzo ye2,374 nyanzvi dzekunze (kusanganisira makumi mana nerimwe ezvidzidzo), zvinosanganisira zana negumi nepfumbamwe uye mazana maviri nemakumi mana nemana ekutsvagisa nzira.
Kuwedzera Kudzokororwa Kwezvinhu Zvitsva Zvinokosha Zvigadzirwa Zvezvishandiso zvekurapa zvehunyanzvi zvine kodzero dzakazvimirira dzepfuma, padanho rinotungamira repasirese, ine kukosha kwakakosha kwekiriniki yekushandisa, uye michina yekurapa mukudiwa kwekiriniki yekukurumidzira, inotsigirwa nemapurojekiti makuru enyika uye zvirongwa zveR&D zvakakosha. Center yaenderera mberi nekuita ongororo yekutanga zvinoenderana nemusimboti wekusadzikisa zviyero uye kufambisa masevhisi mberi. Iyo Center inoenderera mberi nekukwirisa tekinoroji yekuongorora maitiro ezvigadzirwa zvekutanga, uye yakanangana nekiriniki, yakatarisana nevanoongorora vakuru kubva kumadhipatimendi akasiyana ekuongorora kuti vaumbe timu yekuongorora pamwe chete, iine yakazara ongororo maonero anoiswa pamberi nekiriniki, engineering uye zvimwe zvikwata zvehunyanzvi. Munguva yekuongorora, vanoongorora vanotumirwa kuti vatore chikamu mukuongororwa kweiyo rejista yemhando yekutonga system nenzira yekuongorora-pasaiti, kuitira kuti vanzwisise zvine hungwaru uye zvakakwana zvigadzirwa uye zvinokosheswa uye nekuisa mberi mamwe esainzi uye ane musoro maonero ekuongorora. Pamusoro pezvo, inosanganisawo nzira yekutarisa mukutonga kweprojekiti uye kutonga kwemhando kuti uone kupfupikiswa kunoshanda kwenguva yekuongorora chigadzirwa kana ichienzaniswa nemutemo wenguva yekuongorora.
Kukurudzira Shanduko Yekubudirira Kwezvitsva Inotungamirwa neClinical Needs
Clinical evaluation chinhu chakakosha chekutonga chinongedzo mune yekunyora maitiro ezvishandiso zvekurapa zvitsva. Mumakore achangopfuura, iyo Center yakaita rakateedzana rebasa mumunda wekuongororwa kwekiriniki yezvishandiso zvekurapa, zvishoma nezvishoma yakagadziridza pfungwa yekuongorora, zvinodiwa uye chimiro chekuongororwa kwekiriniki kwemidziyo yekurapa, yakapfumisa uye yakawedzera masosi e data rekiriniki, yakagadziriswa mazhinji. nyaya dzakakosha senge maitirwo ezviyedzo zvekiriniki, uye kugadzira nzira nyowani uye maturusi ekuongororwa kwekiriniki, uye zvakagadzira zano resainzi rekuongorora kiriniki. Mukuongorora kwezvakagadzirwa zvigadzirwa, nzira yekuongororwa kwekiriniki yezvigadzirwa zvakasiyana yasvika pakubvumirana mumasangano anodzora uye indasitiri, uye chikamu chemiedzo yekiriniki mukunyoreswa kwechigadzirwa uye marezinesi ekuchinja mapurojekiti ari padanho rinonzwisisika.
Kugadzira hurongwa hwakamisikidzwa hwekuongororwa kwehunyanzvi hwekuongororwa kwekiriniki Mumakore achangopfuura, Center yakagadzira magwaro ekudyidzana epasi rose kuti aongororwe nekiriniki uye akaashandura zvakafanana kuita zvinyorwa zveChina zvemazuva ese, uye akagadzira 8 general guiding misimboti uye 22 inokurudzirwa nzira dzekuongororwa kwekiriniki, iyo inovhara zvizere. nyaya dzinokosha mumunda wekuongorora kliniki. Zvichakadaro, matatu-tier tekinoroji yekuongorora yakamisikidzwa system yakamiswa nehurongwa hwe "general guiding misimboti yekuongororwa kwekiriniki - inotungamira misimboti yekuongororwa kwekiriniki yemhando dzakasiyana dzezvigadzirwa - mapoinzi akakosha ekuongororwa kwehunyanzvi hwekuongororwa kwekiriniki yemhando dzakasiyana dzezvigadzirwa" . Parizvino, pahwaro hwenheyo dzinotungamira, zvinopfuura makumi manomwe zvinotungamira misimboti yekuongororwa kwekiriniki yemhando dzakasiyana dzezvigadzirwa uye anopfuura 400 mapoinzi akakosha ekuongorora kwehunyanzvi hwekuongororwa kwekiriniki akagadzirwa, achinyatso kuona kufukidzwa kwakazara kwezvigadzirwa izvo. inoda kuongororwa nekiriniki pasi pekatatu-tier catalogue yeClassification Catalog yeMedical Devices, uye kuwana kuongororwa kwekiriniki kwemidziyo yekurapa ine chiyero chakajeka chezvigadzirwa, nzira yakajeka yekuongorora uye chaiyo yekuongorora zvinodiwa, iyo inopa nhungamiro yekutanga kune maitiro emakiriniki ekuedzwa kwezvishandiso zvekurapa zvitsva. Inopa gwara rekutanga rezvishandiso zvekurapa zvitsva kuita miedzo yekiriniki.
Kuwedzera kuwanikwa kwezvinhu zvitsva Kuwedzera kuwanikwa kwezvigadzirwa zvehunyanzvi zvekushandiswa kwekiriniki chinhu chakakosha chekuzadzisa zvinodiwa pakurapa kwevarwere vane hosha dzinotyisa. Iyo Center yakaramba ichiteerera kuzvinhu zvakakosha munharaunda iyi uye yakapa mazano akakodzera ekuita. Semuyenzaniso, Center yakaita tsvakiridzo pamusoro pemvumo yezvishandiso zvekurapa, yakanyatsoongorora njodzi uye mabhenefiti ezvigadzirwa, uye yakakwenenzvera zvinodikanwa zvekubvumidzwa nemamiriro ezvinhu, ichikurudzira kubvumidzwa kwezvishandiso zvekurapa izvo zvinoshandiswa kurapa zvirwere zvinouraya zvakanyanya. uye izvo pasina kurapwa kunoshanda kunowanikwa nekukurumidza sezvinobvira; yakaitawo tsvakiridzo pamusoro pekuwedzera kwekushandiswa kwemidziyo yekurapa mukuita kwekiriniki, yakajekesa zvinodiwa pakuwedzera miedzo yekiriniki, uye yakakurudzira kushandiswa kwekiriniki kwemidziyo yekurapa iyo inoshandiswa kurapa hosha dzakakomba dzinouraya izvo hakuna mushonga unoshanda. Kukurudzira kushandiswa kwekiriniki kwezvishandiso zvekurapa kurapa zvirwere zvakakomba izvo pasina nzira inoshanda yekurapa, uye kuzadzisa zvinodiwa nekukurumidza zvevarwere chaivo kurapwa kwekiriniki kusvika pamwero unogoneka uchivimbisa kuchengetedzwa kwekushandiswa kweveruzhinji. midziyo yekurapa; kusunda mberi zvishoma nezvishoma basa rekufambisa rekushandisa data-yepasi rose muBoao Lecheng, kuvandudza nzira dzekuongorora dzekiriniki, uye nekushingaira kuongorora nzira yekushandisa chaiyo-yepasi data yekunyoresa chigadzirwa. Mukupindura kuhurongwa huri pamusoro apa, yakatevedzana yakagadzira Misimboti Inotungamira yeKubvumidzwa Kwemamiriro Ekurapa kweMidziyo Yekunyoreswa, Iyo Technical Guiding Principles for Clinical Evaluation yeReal-World Data yeMedhiyo Devices (yeKuedza Kuitwa), uye yakapinda mukuumbwa kwe iyo Medical Devices
Ramba uchiisa pfungwa dzako panhamburiko
Tarisa pakugadzirisa dambudziko re "mutsipa".
Munyori Mukuru Xi Jinping anokoshesa zvakanyanya kune akakosha matekinoroji. Akasimbisa kuti tinofanira kuisa pfungwa pakutsvakurudza kwakakosha kwekombiyuta, kukurumidza kugadziriswa kwehuwandu hwemishonga, zvigadzirwa zvemishonga, midziyo yezvokurapa, zvirwere uye dzimwe nzvimbo dzedambudziko re "mutsipa"; kukurumidza kugadzirisa iyo pfupi bhodhi yeChina yepamusoro-yekupedzisira michina yekurapa, mhanyisa kiyi yakakosha tekinoroji yekutsvaga, kubudirira mune izvi tekinoroji mabhodhoro emidziyo, uye kuona yakazvimirira uye inodzoreka yepamusoro-yekupedzisira michina yekurapa; kusimbisa tsvakiridzo yekutanga uye sainzi uye tekinoroji innovation kuvaka, uye kuisa hupenyu hwekusimudzira indasitiri yebiomedical mumaoko edu pachedu. Tsvagiridzo yekutanga uye sainzi uye tekinoroji innovation kuvaka kugona, hupenyu hwekusimudzira indasitiri yebiomedical zvakasimba mumaoko edu.
Kuti agadzirise dambudziko re "mutsipa" mumunda wezvigadzirwa zvekurapa, kuongororwa kwehunyanzvi kwezvishandiso zvekurapa kwakaratidza pfungwa nhatu dzinokosha, dzichitarisa kubatanidzwa kwezviwanikwa zvitsva, hunyanzvi mukuita basa, kubudirira muzvinhu zvakakosha kutanga tsvakurudzo nekuisa. endesa mberi zvirongwa zvinoenderana nazvo. Mukubatanidzwa kwezviwanikwa zvitsva, zvichibva pakuunganidzwa kwezviwanikwa zvekuongorora, hurumende yemubatanidzwa, indasitiri, dzidzo, tsvakiridzo nekushandiswa kwemapato ese, mundima yehungwaru hwekugadzira uye biomaterials kuumba yakavhurika uye kugovana kwekuvandudza nekushandira pamwe; mukuvandudzwa kwemuenzaniso webasa, kutsvagisa, kukurudzira kuongororwa kwepakati pesimba rinokwevera pasi zvishoma nezvishoma kusvika padanho rekuvandudza chigadzirwa, kuitiswa kwechigadzirwa chekurapa kufanoongorora; mukubudirira kwenyaya dzakakosha, chiso cheakakwidziridzwa kuti agadzirire China yepamusoro-yekupedzisira michina yekurapa mapfupi bhodhi yemamiriro ekukurumidzira. Panyaya yekupwanya nyaya dzakakosha, pamberi pemamiriro ekukurumidzira ekukurumidza kuita bhodhi pfupi yemidziyo yekurapa yepamusoro muChina, kutsvagisa kwakadzama uye kutsigirwa kwemidziyo yekurapa yepamusoro-soro yakaitwa, uye mimwe mibairo yave kuwanikwa.
Kuvaka Yakavhurika uye Yakagovaniswa Innovation uye Cooperation Platform
Kuti tinzwisise chirongwa chehurongwa hutsva hweshanduko yesainzi uye tekinoroji uye kutarisa kunzvimbo dzakakosha kusimudzira kunyorwa kwezvishandiso zvekurapa zvemumba, Center yakavaka yakavhurika uye inodyidzana yekurapa mudziyo wekuvandudza hurongwa muminda yehungwaru hwekunyepedzera. uye biomaterials pahwaro hwekuongorora uye kutonga mamiriro ebudiriro yeChina mudziyo wekurapa mudziyo, kuedza kumisa hunyanzvi uye kushandirapamwe chikuva chekutarisa kwesainzi kwemidziyo yekurapa, hunyanzvi hwesainzi uye tekinoroji, uye shanduko yechigadzirwa kugadzira chikuva chesainzi uye tekinoroji. hunyanzvi, shanduko yebudiriro, tarisiro yehurumende, uye shanduko yechigadzirwa. Inovavarira kuvaka chikuva chekushandira pamwe chekushandira kutarisisa kwesainzi kwezvishandiso zvekurapa, hunyanzvi hwesainzi uye tekinoroji uye shanduko yechigadzirwa, uye kugadzira yakanaka inopindirana mamiriro ehunyanzvi hwesainzi uye tekinoroji, shanduko yebudiriro, kutonga kwehurumende uye kuzvitonga kweindasitiri.
Kubva payakavambwa uye kushanda muna Chikunguru 2019, iyo Artificial Intelligence Medical Device Innovation Cooperation Platform yakabudirira kuvaka China Artificial Intelligence yezvokurapa mudziyo zvinodiwa, nzira dzekuyedza uye mamwe masisitimu ane hukama, uye nhungamiro dzakakosha senge “Nzvimbo Dzakakosha dzeKudzokorora Kudzidza Kwakadzika- Assisted Decision Making Software for Medical Devices”, “Mapingo Makiyi EOngororo yePneumonia CT Imaging Assisted Diagnostic and Evaluation Software (Trial)”, uye “Nhungamiro Yekunyoreswa Ongororo yeArtificial Intelligence Medical Devices” akagadzirwa uye akaburitswa zvakatevedzana. Nheyo dzakagadzirwa uye dzakaburitswa imwe mushure meimwe, ichipa inodiwa vimbiso yekusimudzira yeAI yezvigadzirwa zvekurapa indasitiri. Pamusoro pezvo, chikuva chakabudirirawo kuvaka dhatabhesi rekutanga rebvunzo rinofukidza nzvimbo dzakawanda dzechirwere senge fundus ultrasound yechirwere cheshuga retinopathy, CT yemabayo, thyroid ultrasound, etc. Databases senge cervical cytopathic mifananidzo uye multimodal mifananidzo ye pathological myopia iri kuvakwa, kupa nzira yekuunganidza, kutonga, uye kushandiswa kwedata rezvigadzirwa zveAI kuti zviunganidzwe uye zvigovane.
Kubva payakavambwa muna Kubvumbi 2021, iyo Biomaterials Innovation Cooperation Platform yakapinda mukugadzirwa kwemisimboti inotungamira, mapoinzi ekuongorora uye tekinoroji nhungamiro inofukidza dzakasiyana siyana senge in vitro diagnostic reagents nemidziyo, yekuwedzera kugadzirwa, ECMO zvishandiso uye zvekurapa zvizorwa, iyo yakasimudzira shanduko uye kushandiswa kwesainzi uye tekinoroji kubudirira mumunda webiomaterials uye yakakosha matekinoroji mumunda wemidziyo yekurapa. Nerutsigiro rwepuratifomu, kufambira mberi kwebudiriro kwave kuchiitwa munzvimbo yekumisikidza-inotsamira mbishi zvinhu zvakadai se polyether ether ketone zvinhu (PEEK) yezvidyarwa; China inoramba ichitungamira nhandare yepasirese mumunda wezvakanakira biomedical zvinhu, senge sodium hyaluronate …… kirasi inotungamira yezvigadzirwa zvitsva iri kuramba ichiwedzera.
Ongorora kugadzwa kwekufanoongorora maitiro ebasa
Pahwaro hwekupfupikisa uye kuongorora kushanda kweshanduko yekuongorora kwechigadzirwa chekurapa uye hurongwa hwekubvumidza, Center for Instrumental Review yakaratidza iyo yepasirese yepamusoro yekuongorora modhi, uye zvishoma nezvishoma yakagadzira hunyanzvi hwekuongorora mazano ebasa, uye nekushingaira kuongorora chikamu chezvekuongorora zviwanikwa. kusvika kumagumo ekugadzirwa kwechigadzirwa chekufambisa mberi kwemuenzaniso webasa. Munguva yakapfuura, kuendeswa kwehurongwa hwekuongororwa kwehunyanzvi hwekurapa uye kuongororwa kweYangtze River Delta sub-center neBay Area District Center yakatsaurirwa kutungamira hutongi hwetsvakiridzo yechigadzirwa chekutanga uye kusimudzira, kutsvagisa kwakadzama uye kuongorora. yezvakakodzera zvemumba-yekupedzisira, zvigadzirwa zvakazvigadzira kuita kupindira kwekutanga muyedzo yekuvandudza chigadzirwa, asi zvakare yakawiriraniswa nekudzidza kwekuongorora kwepakati pesimba rinokwevera remberi rekufambiswa kweiyo chaiyo maitiro, mutyairi. Chigadzirwa chekuongorora nzira, yakatsaurirwa docking purojekiti nzira dzekutungamira uye mamwe mashoko. 2022 Muna 2022, hurumende ichatanga zviri pamutemo ongororo yezvishandiso zvekurapa, ichapa "Code of Practice yeOngororo yeMapurojekiti Akakosha uye Zvigadzirwa Zvinokosha zveKuongorora kweTekinoroji yeMidziyo Yekurapa (yeKuitwa Kwekuedza)", tarisa mapurojekiti akakosha uye ekurapa. zvishandiso zvine akakosha etekinoroji uye yakakosha kukiriniki yekushandisa kukosha, uye kusimudzira kuongororwa kwekudzokorora kwekutanga kupindira mukutsvagisa tsvakiridzo nekuvandudza zvigadzirwa nenzira yekukurumidza kupindira, bhizinesi rimwe, mutemo mumwe, kutungamira kwese kwemaitiro, uye tsvagiridzo nekudzokorora kubatana. .
Tsigira kutsvagisa nekuvandudzwa kwemidziyo yekurapa yepamusoro-soro
China chepamusoro-yekupedzisira michina yekurapa iripo muchikamu chezvipingamupinyi zvakakosha, iyo yese yekugadzira muchina nhanho yakaderera uye dzimwe nyaya. Kuti ugadzirise matambudziko ari pamusoro apa, iyo Center inotarisana nezvinodiwa nenyika zvekufunga kwakasimba, kuronga kwakasimba, kugona indasitiri uye kumberi kwekusimudzira kwesainzi uye tekinoroji, uye kugara uchiunganidza maitiro akakosha uye epakati tekinoroji yekuchengetedza, inotsigira yakakosha musimboti. tekinoroji yekutsvaga nekusimudzira, kukurumidza kuzadzikiswa kweiyo nzira yekugadziriswa kwenzvimbo yepamusoro-yekupedzisira michina yekurapa, uye kukurumidza kugadzira iyo pfupi bhodhi yemhando yepamusoro michina yekurapa. Isu tichaita tsvakiridzo yakadzama pamusoro pemamiriro ezvinhu aripo e "choke point" yemidziyo yekurapa mbishi (zvikamu), kuwedzera rutsigiro rwepamusoro-yekupedzisira michina yekurapa ine yakazvimiririra yakagadziridzwa yakakosha zvinhu zvakaita seECMO, liquid-isina helium magnetic resonance, nezvimwewo, uye kuita nzira dzakasiyana dzekutsvagisa uye kutaurirana kwakasimba. 2022, yekutanga yakagadziridzwa mudzimba proton therapy system, yekutanga kuisirwa mishonga yekurapa ine magineti-mvura levitation tekinoroji, uye yekutanga inoisirwa mishonga yekurapa ine magineti-mvura levitation tekinoroji ichagadzirwa mumusika wepamba. inosimwa kuruboshwe ventricular yekubatsira sisitimu uchishandisa magineti yemvura yekumisa tekinoroji ichatenderwa uye kutengeswa, uye iyo kabhoni ion therapy system ichave yapedza shanduko yayo nekusimudzira; muna 2023, zvigadzirwa zvitatu zveECMO zvinogadzirwa munyika zvichatenderwa uye kutengeswa, uye dambudziko remabhodhi mapfupi emidziyo yekurapa yepamusoro muChina richagadziriswa nenzira yakatsiga uye inoshanda.
Kunamatira Kuvanhu Kutanga
Kuedza kwese-kwese kuchengetedza kudzivirira uye kudzora denda
Muna Zvita 2019, denda idzva rekorona rakangoerekana ratyisidzira zvakanyanya hupenyu uye hutano hwevanhu. Munyori Mukuru Xi Jinping akaita mirairo yakakosha yekudzivirira uye kutonga kwedenda. Pasi pehutungamiriri hwakasimba hweboka rebato reState Drug Administration, ongororo yehunyanzvi hwemidziyo yekurapa, ichitungamirwa nepfungwa yaXi Jinping yesocialism ine hunhu hweChinese munguva itsva, nehana dzakaita zvinodiwa ne "zvina zvakanyanya kuomesesa", zvinotevedzwa. musimboti wekuisa kuchengetedzwa kwehupenyu uye hutano hwevanhu pakutanga, zvinoenderana ne "murairo wakabatana, kupindira kwekutanga, kubvumidzwa kwesainzi", uye "zvina zvakanyanya kuomesesa" zvinodiwa, Zvinoenderana nemisimboti ye "murairo wakabatana. , kupindira kwekutanga, kuongororwa kwepa-site uye kubvumirwa kwesayenzi" uye zvinodiwa zvekuchengetedza kuchengetedzwa kwechigadzirwa, kubudirira uye unhu hunodzoreka, tapedza basa rekuongorora rekukurumidzira nehupamhi hwepamusoro, iro rakapa chivimbiso chinoshanda chekudzivirira uye kutonga kwedenda. .
Kuburitswa kwemapoinzi ekuongorora kwechimbichimbi
Mushure mekubuda kwedenda, State Drug Administration (SDA) yakatanga nzira yekubvumidza yechimbichimbi yezvishandiso zvekurapa kekutanga, uye yakaronga huwandu hwezvigadzirwa kuti zvibatanidzwe mumvumo yechimbichimbi. Kuti utsigire vagadziri kuti vagadzire matsva ekuona coronavirus ekudzivirira uye kutonga nekukurumidza uye nekunyatso kunyoresa pamusika, zvakanyanya kukosha kuburitsa magwaro ekutungamira panguva yekutungamira kuvandudzwa kwechigadzirwa uye kunyoresa. Pahwaro hwekuunganidza mabhuku akakodzera uye kukumbira maonero enyanzvi, iyo Center for Instrumental Ongororo (CIR) yakatsvaga uye yakagadzira uye yakadhirowa pasi rose "Maiyi Mapoinzi eTekinoroji Ongororo yeKunyoreswa kwe2019 Novel Coronavirus Nucleic Acid Detection Reagents" uye "Kiyi. Mapoinzi eTekinoroji Ongororo yeKunyoreswa kwe2019 Novel Coronavirus Antigen/Antibody Detection Reagents ”, ayo anoitirwa kupa gwara kune vanonyorera mukugadzirira ruzivo rwekuzivisa, kuve nechokwadi chemhando yekuongorora, uye nekukasira kubvumidzwa kwevatsva vanoongorora coronavirus reagents. kushandiswa mukudzivirira nekudzora denda. Iwo matsva ekuona coronavirus reagents pamusika anopa hunyanzvi hwaro. Munguva yedenda, iyo Inotungamira Yekudzokororwa Kunyoreswa kweNew Coronavirus (2019-nCoV) Antigen Detection Reagents, Mazano eOngororo yePneumonia CT Imaging Inobatsirwa Kuongororwa uye Kuongorora Software (Muedzo), Mazano eKudzokorora kweExtracorporeal Membrane Lung Oxygenation (ECMO) Zvishandiso. , uye mamwe magwaro akakosha ekutungamira akaumbwa uye akaburitswa maererano nemamiriro ekurwisa denda, ayo anopa nhungamiro inoshanda yekuongorora kwehunyanzvi uye tsvakiridzo nekuvandudzwa kwezvigadzirwa zvebhizinesi.
Kuita wongororo yekukurumidzira
Famba pamirairo uye utore mitoro inorema. Mushure mekunge State Drug Administration yatanga nzira yekubvumidza yechimbichimbi, Center for Instrumental Ongororo (CIRC) yanga ichikurumidza kuita basa rekuongorora zvechimbichimbi, ichiratidza hunhu hwesainzi uye kugona kwakanyanya, uye kunyatso kudzora kunaka kwezvigadzirwa. Kuburikidza nekuvakwa kwesainzi kwekuchengetedzwa kwechigadzirwa uye inobudirira yekuongorora modhi, isu tinoita mutongo wakakwana pane izvo zvinodikanwa zvekuongorora zvezvakasiyana zvigadzirwa zvitsva, kutaurirana zvine hungwaru nekuongorora, kuongorora sisitimu uye ongororo yenyaya dzetatu, uye pamwe nekusimudzira ongororo yekukurumidzira. Specific modus operandi yeEmergency Review Working Group inosanganisira kupindira mukugadzirwa kwechigadzirwa pachine nguva, kutaurirana zvakananga neboka reR&D, kunzwisisa mamiriro eR&D, uye kutungamira magadzirirwo echigadzirwa uye nzira dzekuvandudza; kuitisa panguva yakakodzera tekinoroji ongororo yezvigadzirwa zvichaziviswa, uye kutungamira vanonyorera vanyoreri kuti vaite basa rekuzivisa rekunyoresa kekutanga; kuita ongororo yenguva yenguva yeruzivo rwakaunzwa nemabhizinesi, uye kupindura kumatambudziko emabhizinesi mukusimbisa zvigadzirwa munguva yemaawa makumi maviri nemana. Pakutanga kwedenda, Center for Instrumental Ongororo yakapedza ongororo yechina nucleic acid yekuyedza reagents emabhizinesi mana mumazuva mana, uye pane imwe nguva, maererano nemamiriro ekurwisa denda, Center yakapedzwa nesainzi uye nemazvo. ongororo yechimbichimbi yemaantigen test reagents, midziyo yemumba yeECMO uye zvimwe zvigadzirwa, izvo zvakaita basa rakanaka mukuderedza kushomeka kwemidziyo yekurapa inorwisa denda. Sekureva kwehuwandu, pakupera kwa2023, anopfuura zana nemakumi mashanu matsva ekuona coronavirus reagents, uye anopfuura makumi matatu ane hukama zviridzwa, software nemapfekero zvakabvumidzwa kushambadzira, zvinosanganisira midziyo yekuchenesa ropa, mafevha, michina yeECMO uye zvimwe zvakakosha zvekutsigira, izvo. zvakazadzisa zvinodikanwa zvekudzivirira nekudzora denda.
Nguva yekutumira: May-23-2024