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Xu Jinghe: Kunaka uye kutora mishoni uye kushanda nesimba kupenda chitsauko chitsva

Chinyorwa / Kubva mukutaura kwaXu Jinghe, Mutevedzeri weMutungamiriri weHurumende Drug Administration, pamusangano wezvokurapa wezvehupfumi wezvehupfumi musangano weSouthern Institute musi wa25 Gunyana.

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Zvishandiso zvekurapazvinhu zvakakosha zvekusimudzira hutano hwevanhu nekuvandudza hutano hwevanhu.Kubudirira kwemudziyo wekurapaindasitiri ine chekuita nekuitwa kwehurongwa hweHutano China uye Kugadzira Nyika Ine Simba.Bato reCentral Committee uye State Council inokoshesa zvakanyanya kune inovandudza uye yemhando yepamusoro budiriro yemudziyo wekurapaindustry.Munyori Mukuru Xi Jinping akaramba achisimbisa kukosha kwekukurumidza kugadzirisa iyo pfupi bhodhi yeChina yepamusoro-yekupedzisira michina yekurapa, kukurumidza kutsvagisa yakakosha tekinoroji, kutyora mabhodhoro etekinoroji nemidziyo, uye kuwana yakazvimirira kutonga kwepamusoro-magumo. midziyo yekurapa.Kuti utarise patsvakiridzo yakakosha yetekinoroji, mhanyisa mhinduro yehuwandu hwemishonga, midziyo yekurapa, michina yekurapa, majekiseni uye dzimwe nzvimbo dze "mutsipa" dambudziko.Kusimbisa kutsvagisa kwekutanga uye sainzi uye tekinoroji innovation kuvaka, hupenyu hwekuvandudza indasitiri yebiomedical zvakasimba mumaoko edu.

Mumakore achangopfuura, State Drug Administration yakanamatira kupfungwa yaXi Jinping yesocialism ine hunhu hweChinese munguva nyowani segwara rakakosha, yakatora chengetedzo nekusimudzira hutano hweveruzhinji sechinangwa chakanakisa, yakamhanyisa kusvetuka kubva kunyika huru yekugadzira. midziyo kune nyika yakasimba yekugadzira michina sechinangwa chekusimudzira, inotorwa sainzi, kutonga kwemutemo, kudyidzana kwenyika uye zvechizvino-zvino senzira yebudiriro, inoteedzera hukuru hwevanhu uye hukuru hwehupenyu, uye nekuziva zvakanyanya kubatanidza chikonzero chemutemo wemidziyo yekurapa mukati. basa reBato nenyika.Tichava nehanya nekubatanidza chikonzero chekutonga kwemidziyo yekurapa mubasa reBato neHurumende, kusimudzira kuvakwa kwemutemo wekutonga kwemidziyo yekurapa, kuita chirongwa chesainzi chekutonga kwezvinodhaka kweChina zvakanyanya, kudzamisa shanduko yekuongorora uye kubvumidza hurongwa hwemidziyo yekurapazvakanyanya kusimba, uye kutora chikamu mukutsinhana kwenyika nekudyidzana kwemutemo wemidziyo yekurapanenzira yakadzama, kuitira kuti kusimudzire budiriro yemhando yepamusoro yeindasitiri utsva nekutonga kwesainzi uye utongi hwemazuva ano, uye kuchengetedza kodzero dzehutano nezvido zveveruzhinji.

 

Indasitiri yakasimba inoda kudzorwa kwakasimba, uye kudzora kwakasimba kunogadzira indasitiri yakasimba.Pamberi penguva itsva yekuwedzera kunetseka kwevanhu pamusoro pemufaro uye hutano, uye nzira itsva yekuvandudza yemukati nepasi rose kutenderera kweviri, China.mudziyo wekurapaindasitiri yanga ichivandudza nekuvandudza, kufora kumberi nekurota, uye yaona budiriro kubva padiki kusvika pakukura, kubva kune isina simba kusvika kune yakasimba, uye yapinda mudanho idzva rekusimudzira re "kumhanya padivi, kumhanya kwakafanana, kutungamira" uye zviripo.Parizvino, indasitiri yemidziyo yekurapa yeChina inopa maitiro anotevera:

Chekutanga, chiyero cheindasitiri chiri kukura zuva nezuva.Mumakore achangopfuura, indasitiri yemidziyo yekurapa yekuChina yave kukura nekukurumidza, iine mabhizinesi ekugadzira anopfuura zviuru makumi matatu nezviviri uye anopfuura zviuru zvitatu nemazana maviri nemakumi manomwe nesere, 000. gore, iro rakakwira zvakanyanya kudarika mwero wekukura kweindasitiri yemishonga yeChina uye kukura kweindasitiri yepasi rose yemidziyo yekurapa.Sekureva kweSouthern Institute of Pharmaceutical Economics yeState Drug Administration, mari yekuChina yemidziyo yekurapa ichapfuura mazana maviri emabhiriyoni emadhora ekuAmerica muna 200, uye chikamu chemusika wepasi rose wemidziyo yekurapa chichasvika 28.5%.

Chechipiri, maitiro eindasitiri ari kujeka.Iko kukurumidza kusimudzira kwemaindasitiri masumbu, kusangana kwemaindasitiri uye kuchinjisa maindasitiri nenzira yakafanana, kuumbwa kweiyo maindasitiri masumbu chiyero uye akasiyana maficha.Bohai Rim, Yangtze Rwizi Delta neGuangdong, Hong Kong neMacao Bay Area sezvo masumbu makuru matatu echinyakare ari kuramba achikura nekumhanya, dzimwe nzvimbo dzekusimudzira tekinoroji, nzvimbo dzekusimudzira hupfumi uye tekinoroji uye mamwe masumbu makuru eindasitiri ari kuwedzera. , achigadzira masumbu eindasitiri edunhu ane hunyanzvi hwekuita niche minda.Sepakati peiyo indasitiri yeketani, kuwedzera kwehukuru hweindasitiri yemidziyo yekurapa inofambisa kusimudzira kweiyo indasitiri chain.

Chechitatu, nhanho yetekinoroji iri kuwedzera kukwidziridzwa.Mumakore achangopfuura, China haina kungowedzera kukurumidza kugadzira mabhodhoro uye mapfupi mabhodhi muminda yezvakakosha zvikamu, basic software, basic materials uye basic tekinoroji, asi zvakare yakakohwa mhedzisiro inoshamisa mukuvandudzwa kwekuita kwechigadzirwa uye mhando yemhando yepamusoro-. kupedza michina yekurapa, kupaza akati wandei ehunyanzvi hwekuita zvinhu zvakakosha senge superconducting magineti, ma electron accelerators, RF/spectrometers, nezvimwewo, uye hunyanzvi hwekuita tekinoroji yeproton uye kabhoni ion therapy system, marobhoti ekuvhiya emapfupa, chizvarwa chechitatu chemoyo wekugadzira. , yakanangana neFocused Ultrasound Therapy System, Gene Sequencing System, nezvimwewo vari pedyo kana kuti vasvika padanho repamusoro repasi rose.

Chechina, kugona kwekuvandudza kweindasitiri kuri kuwedzera zuva nezuva.Mumakore achangopfuura, State Drug Administration kukurudziramudziyo wekurapatekinoroji innovation policy inoramba ichimanikidza.Kubva gore rino, zvigadzirwa zvehunyanzvi zvakaramba zvichichengetedza kukurumidza kwekukura, uye kusvika pari zvino 41 zvigadzirwa zvitsva zvakabvumidzwa kuti zvinyorwe.Zvimwe zvigadzirwa zvehunyanzvi, senge brain pacemaker, zvakahwina mubairo wekutanga wekufambira mberi kwesainzi uye tekinoroji.

Chechishanu, iyo yemhando yepamusoro system iri kuramba ichiwedzera kukwana.Mumakore achangopfuura, nekufambira mberi kwakatsiga kweiyo indasitiri yemhando yehurongwa hwekuratidzira kuvaka, kutarisa uye kugadzirisa kuedza kuri kuramba kuchiwedzera, basa guru ramabhizinesi rekusimbisa kuitiswa kwemhando yehutongi hwemhando yeindasitiri yemidziyo yekurapa inoramba ichivandudza.

Yechitanhatu, pesvedzero yenyika yose iri kuwedzera.Mumakore achangopfuura, pesvedzero yepasi rose yemabhizinesi emidziyo yekurapa yeChinese yave kuwedzera.Mabhizinesi mazhinji eChinese ane tekinoroji yepamusoro, mashandiro anoenderana uye mhando yemhando yakashandisa zano rekutumira zvigadzirwa zvavo kugungwa uye zvishoma nezvishoma vakaratidza pesvedzero yavo yepasirese.Zvinoenderana nerunyorwa rwepamusoro 100 pasi rosemudziyo wekurapavagadziri muna 2022 vakaburitswa newebhusaiti ine mvumo yeindasitiri yemidziyo yekurapa, makambani gumi nemaviri eChinese akabudirira kupinda muchirongwa.

Chirongwa che "Healthy China 2030" chinoti hutano chinhu chinodiwa pakusimudzira budiriro yevanhu uye chinhu chakakosha chekusimudzira hupfumi nemagariro.Senzira yakakosha yekuchengetedza hutano hwevanhu,midziyo yekurapakuita basa rinowedzera kukosha muminda yekudzivirira, kuongororwa uye kurapwa.Kubva pane zvinodiwa zvekukurumidzira zvenyika uye kudiwa kwenguva refu, indasitiri yezvishandiso zvekurapa ibasa rakakosha rinoda kutarisa pane zvinobatsira zviwanikwa, uye inyanzvi iri kusimukira indasitiri ine kukura kwakasimba, kukosha uye kukurudzira.Tsvagiridzo yakazara uye mutongo, parizvino, indasitiri yemidziyo yekurapa yeChina ichiri mu "nguva yebudiriro yegoridhe".Pasi perutsigiro runoenderera mberi uye kugoneswa kweruzivo, digitization uye hungwaru, shanduko nyowani zhinji dzichabuda muzvikamu zvakasiyana uye mateki e.midziyo yekurapa.Semuyenzaniso, chizvarwa chitsva chekufungidzira kwezvokurapa chichakurumidzisa kukura kwehungwaru, kure, miniaturised, kukurumidza, kwakarurama, multi-modal fusion, kuongororwa uye kubatanidzwa kwekurapa, uye kuenderera mberi nekuvandudza zvishoma nezvishoma nzira uye kushanda kwekuongorora genetic, concomitant diagnosis tumors uye kuongororwa kwekutanga, kudzivirira kwechirwere chetachiona uye kuongororwa, uye kuonekwa kwezvirwere zvinobuda.Plant interventional device tekinoroji yekusimudzira nzvimbo yakapamhama, hunyanzvi uye kuvandudzwa kwezvitsva zvinomera zvemoyo pacemakers, neurostimulators uye zvimwe zvigadzirwa, zvinoda kutarisisa kuvandudzwa kwetishu kuvandudzwa uye kugadzirisa basa rebioactive composite zvinhu tsvakiridzo nekusimudzira uye shanduko, uye kusimudzira kushandiswa kwezvinhu zvepamberi, engineering yetishu, 3D kudhinda uye humwe hunyanzvi.

 

Kutanga, kuvandudza hurongwa hwekugadzirisa, kusimbisa nheyo yekuvandudza.2021 yakagadziridzwa Mitemo yeKutarisira uye Kutungamira kweMedical Devices, mutemo wemutemo wekubatanidza uye kudzamisa zvakabudirira zvekuvandudzwa kwekuongorora uye kubvumidza sisitimu yezvishandiso zvekurapa, kugadzwa kwakazara kwechirongwa chekunyoresa mudziyo wekurapa, kuongororwa kwekiriniki kwezvinodiwa zveyepasirese mwero, kuitiswa rekodhi sisitimu yemasangano ekuyedzwa kwekiriniki, kuitiswa kwekiriniki yekuyedza purojekiti yaireva mvumo system, inobvumira mabhizinesi kuita chigadzirwa chekuzviongorora zvinoenderana nemutemo.Pamusoro pezvo, hurongwa hwemvumo yezvimiro uye yakawedzera kiriniki yekuyedza system yakamiswa kuti ipe kukosha kuwongororo uye kubvumidzwa kwezvishandiso zvekurapa zvine hunyanzvi uye kutsigira kusimudzirwa kwekiriniki uye kushandiswa kwezvigadzirwa zvitsva.Kusvika pari zvino, hupenyu hwese kutenderera kwemhando uye kuchengetedza manejimendi yemidziyo yekurapa yakaumbwa ne "Regulations for the Supervision and Administration of Medical Devices" seyo musimboti, inotsigirwa negumi nemana inotsigira mirau, anopfuura 140 magwaro enormative, kupfuura. 600 inotungamira misimboti yekunyoresa uye ongororo yehunyanzvi, uye anopfuura 760 tekinoroji yekuongorora mapoinzi, ayo anopa mutemo wakasimba wemutemo wekuvandudza uye kwemhando yepamusoro indasitiri yemidziyo yekurapa.

Chechipiri, kurongeka kwezvinonyanya kukosha, kufamba kwegwara rekusimudzira.2021, State Drug Administration uye akati wandei madhipatimendi akabatana akapa "14th Five-Year Plan" yekuchengetedzwa kwenyika zvinodhaka uye kusimudzira budiriro yemhando yepamusoro, zvakajeka pakupera kwe "14th Five-Year Plan" nguva, iyo huwandu hwekutonga kwezvinodhaka padhuze nedanho repamusoro repasi rose, kuchengetedzwa kwezvinodhaka uye kuchengetedzwa kwedanho rekusimudzira kweindasitiri yemidziyo yekurapa.Pakupera kwe "14th Five-Year Plan" nguva, huwandu hwekutonga zvinodhaka hunenge hwave padyo nedanho repamusoro repasi rose, mwero wekuchengetedzwa kwezvinodhaka nekuchengetedzeka ucharamba uchivandudza, uye vanhu vachagutsikana zvakanyanya nezvimwe. pakusununguka nekunaka uye kuchengetedzwa kwezvinodhaka.Nzvimbo yekutonga yekutsigira kusimudzira kwemhando yepamusoro yeindasitiri ichave yakagadziridzwa, shanduko yekudzokorora uye hurongwa hwekubvumidza hucharamba huchidzika, huwandu hwemishonga inodiwa yekiriniki ichabvumidzwa, rondedzero yekiriniki-yakakosha. Mishonga inovandudzwa ichakwidziridzwa, uye zvinodhaka zvepasi rose nemidziyo yekurapa yakatsvagirwa kuChina ichanyorwa mundima nekukurumidza.State Drug Administration, pamwe neBazi reMaindasitiri neRuzivo rweTekinoroji, Bazi rezvehutano nemamwe madhipatimendi, vakabatana vakapa "Chirongwa cheMakore mashanu" chekuvandudza indasitiri yemidziyo yekurapa, zvichijekesa kuti panosvika gore ra2025, chiyero cheindasitiri yemidziyo yekurapa yeChina ichavandudzwa zvakanyanya maererano nenheyo yepamusoro uye yemazuva ano yeketani yemaindasitiri, michina yekurapa yakajairika ichapihwa zvinobudirira, uye mwero wepamusoro-yekupedzisira mashandiro emidziyo yekurapa uye mhando ichavandudzwa zvakanyanya, kutanga kuumba hwaro hwehutano hweveruzhinji nemidziyo yekurapa.Kuita uye nhanho yemhando yepamusoro-yekupedzisira michina yezvigadzirwa zvekurapa ichave yakavandudzwa zvakanyanya, uye yakakwana yekutsigira kugona kwehutano hweveruzhinji uye zvekurapa uye zvehutano zvinodiwa zvichatanga kuumbwa.Mumakore achangopfuura, State Drug Administration nemadhipatimendi akakodzera vakapa pamwe chete Chirongwa cheAction for Concentrated Attack pane High-end Medical Equipment, Implementation Plan yeRobhoti + Application Action, uye Mafungiro Anotungamira paKukurumidzira Kuvandudzwa kweIndasitiri Yezvokurapa, izvo zvakasimbisa dhizaini yepamusoro-soro uye kubatsira mutsigiro yemitemo kuvhura nzira yakakura yebudiriro yekuvandudza uye yemhando yepamusoro yeindasitiri yemidziyo yekurapa.Nzira yebudiriro yakakura.

Chechitatu, kubatanidza zviwanikwa zveutongi uye kuunganidza masimba ebudiriro.Mumakore achangopfuura, State Drug Administration yakasimbisa kushandira pamwe nemadhipatimendi mazhinji, uye yakagadzira hungwaru hwekugadzira.mudziyo wekurapainnovation mushandirapamwe chikuva uye biomaterials innovation yekudyidzana chikuva, kusimudzira kushanda kwakabatana kweindasitiri, academia, kutsvagisa, kushandisa uye manejimendi, uye kuunganidza simba remapato ese kuti aumbe kuwedzera kwesimba rekinetic yekusimudzira kwemhando yepamusoro yekuvandudza maindasitiri.State Drug Administration yakabatana pamwe neBazi reIndasitiri neRuzivo rweTekinoroji (MIIT) basa rekufumura rondedzero yezvigadzirwa zvehunyanzvi zvehungwaru zvekurapa uye biomaterials, vachitarisa kumberi kwekuvandudza tekinoroji, kuisa pamberi, kusarudza yepamusoro-soro.midziyo yekurapa, uye kutarisa parutsigiro rwemhando yepamusoro yekuvandudzwa kwemidziyo yekurapa kuunganidza simba nekugonesa.Shingairira Bazi reSainzi neTekinoroji kutsvagisa nekuvandudzwa kwezvinhu zvitsva zvekuona coronavirus, Bazi reMaindasitiri neRuzivo rweTekinoroji yakakosha extracorporeal lung membrane oxygenation muchina (ECMO) chirongwa chekunyoresa chigadzirwa.Iyo Yangtze Rwizi Delta, iyo Bay Area, mbiri yekuongororwa kwemidziyo yekurapa uye yekuongorora diki-centre iri kushanda zvakatsiga, kushandira zvirinani hurongwa hukuru hwenyika, uye kushandira zvirinani indasitiri yezvishandiso zvekurapa nekusimudzira kwemhando yepamusoro.

Chechina, kudzamisa kuvandudzwa kwemvumo uye nzira yekuvandudza.Mumakore achangopfuura, iyo State Drug Administration yakaramba ichidzamisa shanduko yekudzokorora uye kubvumidza system, zvinoenderana ne "Special Ongororo Maitiro eInnovative.Mishonga Yezvokurapa” uye “Maitirwo Emvumo Yekutanga eMidziyo Yezvokurapa”, uye ipa pamberi pakuongorora nekubvumidzwa kwemidziyo yekurapa yepamusoro-soro ine hunyanzvi hwekutanga hune patents ekugadzirwa muChina, uye zvigadzirwa zvine yekutanga kugadzirwa kwemumba kweiyo huru yekushanda musimboti / nzira ye chigadzirwa, uye izvo zvigadzirwa zvine kukosha kwakakosha kwekushandiswa kwekiriniki uye zvinodikanwa nekukurumidza mukiriniki, uye kubvumira zvigadzirwa izvi "kumira zvakaparadzana, zvichimhanya munzira yese".Kusvika pari zvino, mazana maviri nemakumi matatu ezvigadzirwa zvekurapa zvakaita semumba uropi pacemaker, kabhoni ion therapy system, proton therapy system, 5.0T magineti resonance imaging system, panoramic dynamic PET/CT, yechitatu-chizvarwa mwoyo wekuzvarwa, tsinga dzeropa uye zvimwe hunyanzvi hwekurapa. zvakatenderwa uye zvakanyorwa pamusika, zvichiona kubudirira kwemidziyo yemumba yepamusoro-yekupedzisira.Mumakore achangopfuura, Medical Device Technical Review Center yakaramba ichivandudza zvirongwa zvekuongorora uye yakagadzira nzira yekushanda yekushandura tarisiro yehunyanzvi hwekurapa tekinoroji kuenda kudanho rekuvandudza chigadzirwa, ichitarisa pane zvigadzirwa zvinogona kubudirira muhunyanzvi matekinoroji, zvakakosha zvinhu uye. zvakakosha, uye vane kodzero yakazvimirira yehungwaru pfuma, seECMO system, proton carbon ion therapy system uye ventricular assist system uye mamwe epamusoro-ekupedzisira maturusi ekurapa, nezvimwewo, uye kupindira kumberi kutungamira nekumhanyisa The kiyi yakakosha tekinoroji yekutsvaga uye. kusimudzira, kuitira kutungamira nzira, kusimudzira michina yekurapa yeChina yepamusoro kuti iwane budiriro huru.Parizvino, State Drug Administration yakamisa zviteshi zvipfumbamwe zvekushandisa zvekurapa kutsigira indasitiri yemidziyo yekurapa indasitiri uye kusimudzira kwemhando yepamusoro.

Chechishanu, kugadzira sainzi yekudzora kusimudzira danho rebudiriro. Muna 2019, iyo State Drug Administration yakatanga China yeDrug Regulatory Science Action Plan kuti ienderane nezvinetso zvitsva zvinounzwa nehunyanzvi hutsva, zvigadzirwa, maitiro, zvigadzirwa, mabhizinesi uye nzira dzekushanda kune iyo. kubvumidza uye kudzora, uye kugadzira zvishandiso zvitsva, zviyero, uye nzira dzekutonga, mukuyedza kuita kuti mutemo uve mutungamiri uye unogonesa kusimudzira uye kwemhando yepamusoro indasitiri.Kusvika ikozvino, SDA yaziva 9mudziyo wekuraparegulatory sainzi mabhesi ekutsvagisa, makumi maviri nemapfumbamwe marabhoritari ane hukama nemunda wemidziyo yeSDA, uye akatanga mabheji maviri emapurojekiti esainzi.Nekudzika kuri kuwedzera kwekutsvagisa kwesainzi, maturusi matsva, zviyero uye nzira dziri kushandiswa mukuongorora uye kubvumidzwa kwemidziyo yekurapa nekutarisa uye manejimendi, ichipa rutsigiro rwesainzi uye tekinoroji uye nerutsigiro rwehuchenjeri mukusimudzira hunyanzvi hwemaindasitiri nemhando yepamusoro.

Yechitanhatu, kudzamisa shanduko uye kubatana kuwedzera nzvimbo yekusimudzira.Mumakore achangopfuura, iyo State Drug Administration kuwedzera shanduko dzepasirese uye kushandira pamwe, kubatsira iyo yepasirese yezvokurapa mudziyo wekudzora kuchinjika, kurongeka uye kuvimba, yakatungamira kuvandudzwa kwezvishandiso zvina zvepasirese zvekurapa kiriniki evaluation manejimendi manejimendi, yakatungamira kuvandudzwa kwe "medical magetsi emidziyo Chikamu. 2-90 yakakwirira-kuyerera yekufema kurapa midziyo, yekutanga kuchengetedza uye yekutanga kuita ” "in vitro diagnostic test system - nucleic acid amplification nzira yekuona novel Zvinodiwa uye Kurudziro yeCoronavirus (SARS-CoV-2)" uye mamwe matanhatu epasi rose zviyero.Parizvino, huwandu hwese hwezviyero zvemidziyo yekurapa muChina hwasvika 1,961, uye dhigirii rekuenderana nemitemo yepasi rose rasvika kupfuura 90%.Isu tinoshingairira kutora chikamu muzviitwa zve IMDRF, GHWP nemamwe masangano epasi rese kubatsira kusimudzira pasi rose.mudziyo wekuraparegulatory convergence, kudyidzana uye kuvimbana, uye kubatsira michina yeChina yezvokurapa kuti zvifambe pasi rose.

 

Munyori Mukuru Xi Jinping akasimbisa kakawanda kuti hutano hwevanhu chiratidzo chakakosha chekubudirira kwenyika uye simba renyika;kuti kuomerera kune hutsva kune nzvimbo yepakati mumamiriro ese echizvino-zvino cheChina;uye kuti budiriro yemhando yepamusoro ibasa rekutanga mukuvakwa kwakazara kwenyika yemazuva ano yesocialist.Chiratidzo chakakosha, chinzvimbo chepakati uye basa rekutanga rinotsanangura zvakanyanya kukosha kwehunyanzvi uye chinzvimbo chakatanhamara chehutano hwevanhu, hutsva uye budiriro yemhando yepamusoro mukuvaka kwesocialist yemazuva ano.Chirevo che20th Party Congress chinokurudzira kuti tinofanira kusimbirira kuisa pfungwa yekusimudzira hupfumi pahupfumi chaihwo, kusimudzira maindasitiri matsva, kukurumidza kuvakwa kwenyika yakasimba yekugadzira, nyika yakasimba yemhando, nyika ine network yakasimba, dhijitari yakasimba. China uye zvichingodaro.Kukurudzira kubatanidzwa uye kukwidziridzwa kwemapoka emaindasitiri ari kusimukira, kuvaka chizvarwa chitsva chehunyanzvi hweruzivo, hungwaru hwekugadzira, biotechnology, simba idzva, zvishandiso zvitsva, midziyo yepamusoro, girinhi kuchengetedzwa kwezvakatipoteredza uye dzinoverengeka injini dzekukura.25 Nyamavhuvhu, musangano mukuru weState Council wakafunga uye wakatora chirongwa che "Pharmaceutical indasitiri yemhando yepamusoro yekuvandudza chiitiko (2023-2025)", "indasitiri yemidziyo yekurapa yemhando yepamusoro chirongwa chekusimudzira chiitiko (2023-2025)" uye "indasitiri yemidziyo yekurapa yakakwirira. -urongwa hwekusimudzira hwekuita (2023-2025)".Development Action Plan (2023-2025) yeMedical Equipment Industry.Musangano uyu wakasimbisa kuti indasitiri yemishonga neindasitiri yemidziyo yekurapa ndiyo hwaro hwakakosha hwekuchengetedza hutano, uye zvine chekuita nehupenyu hwevanhu uye hutano uye mamiriro ese ebudiriro yemhando yepamusoro.Nhamburiko dzinofanirwa kuitwa kuvandudza kusimba uye kuvandudzwa kweindasitiri yemishonga neindasitiri yemidziyo yekurapa, kusimudzira kugona kwemishonga yemhando yepamusoro, matekinoroji akakosha uye mbishi uye zvinhu zvekubatsira, uye kukurumidzira kugadziridzwa kwebhodhi pfupi rekurapa kwepamusoro. midziyo muChina.Ita sarudzo huru uye kutumirwa kweCPC Central Committee uye State Council, kukurumidza kuvandudzwa kwemitemo yemidziyo yekurapa yeChina, kusimudzira kufambira mberi kweChina kubva kunyika yakakura kuenda kunyika yakasimba mukugadzirwa kwemidziyo yekurapa, kubva kumagumo ekutonga kwemidziyo yekurapa, isu tichatarisa pane zvinotevera zvikamu zvebasa:

Chekutanga, ramba uchidzamisa ongororo uye kubvumidza shanduko yehurongwa, kusimudzira nhanho yezvishandiso zvekurapa pamusika.Panguva ino, Chinamudziyo wekurapaindasitiri yapinda munguva itsva yekuzvimiririra hunyanzvi uye budiriro kunyanya kubva mukutevedzera kutevedzera.Iko kugona kugadzira michina yekurapa uye kugona kuongorora zvigadziriso zvekurapa zvave zvinhu zvakakosha kuyera kukwikwidza kwepasirese kwenyika nedunhu zvigadzirwa zvekurapa.Innovation ndiyo yekutanga simba rekufambisa kutungamira budiriro uye sosi huru yekusimudzira shanduko.Zvekutariswa kusati kwamusika, chigadzirwa ndimambo.Isu tichagara tichinamatira kumweya wesainzi uye nemweya wekutonga kwemutemo, tichishingairira kuenderana nezvinodiwa zvitsva zvepasi rose zvekurapa kwesainzi uye tekinoroji kufambira mberi uye budiriro yemaindasitiri, tichishingairira kuenderana nezvinodiwa zvitsva zvevarwere kurapwa kwekiriniki, kudzika zvisingaite. Shanduko yeongororo yemidziyo yekurapa uye hurongwa hwekubvumidza, uye nekukurudzira tsvakiridzo yesainzi pamusoro pekutonga kwemidziyo yekurapa, inovandudza ongororo uye hurongwa hwekubvumidza, kugadzirisa ongororo nekubvumidza maitiro, nekuvandudza nzira yekuongorora uye yekubvumidza, kuti isu anogona, nekuita kurinani.ikurumidze kumhanya kwezvishandiso zvekurapa zvitsva pamusika.

Chechipiri, tichaita zvese zvatinogona kusimudzira kuvakwa kwemutemo wezvishandiso zvekurapa, uye nekukasira kuumbwa kweshanduro yakakwidziridzwa yemutemo wekutongamidziyo yekurapa.Mutemo weMedical Device Management wakaverengerwa mukuronga kwemutemo kwe14th National People's Congress Standing Committee, chinova chiitiko chakakosha munhoroondo yeChina chekurapa mudziyo.Mutemo mudziyo wekugadzira hupenyu hutsva.Nzira yemutemo inzira yekudzamisa kunzwisisa kwemutemo wemudziyo wekurapamanejimendi, uye maitiro ekusimudzira nhanho yesainzi, yepamutemo, yepasirese uye yemazuva ano yekutarisira mudziyo wekurapa.Tichaomerera kune dambudziko rekutarisa, chiono chepasirese, shanduko uye hunyanzvi, kusimudzira kwesainzi, uye kuunganidza simba rakawanda rekuita kuedza kwese kugadzira Medical Devices Management Law ine mamwe emazuva ano pfungwa, inowirirana hunhu, akazara masisitimu, uye mamwe magadzirirwo ane ruzha, uye kuwedzera kusimudzira uye kusimudzira mashandiro emidziyo yekurapa yeChina.Mutemo urongwa hwemasangano kuti vanhu vafare.Tichatevedzera mutemo wesainzi, wedemocracy uye wakavhurika, uye tinogashira nemoyo wese zvikamu zvevanhu kuti vatore chikamu mumutemo weMedical Devices Management Law uye edza kupa hungwaru nesimba rako.

Chechitatu, tichaita zvakadzama zviito zvekubatanidza nekuvandudza kuchengetedzwa kwezvinodhaka, uye nekunyatsosimbisa kutariswa kwemhando yepamusoro.midziyo yekurapamuhupenyu hwavo hwose.Kwemakore, tichitarisa panjodzi uye mutoro, hurongwa uye kugona, kunaka uye kugona, takaenderera mberi nekuita hutongi hwemudziyo wekurapakunaka uye kuchengetedzwa, kwakasimbiswa mhando dzakakosha, hukama hwakakosha, nzvimbo dzakakosha uye matunhu akakosha, uye yakasimbirira pakuvandudza nzira yekutonga, kusimudzira masimba ekutonga, kuongorora nyaya huru uye kudzora njodzi dzekuchengetedza.Parizvino, zvinoenderana nezvinodiwa zvekubatanidzwa kwekuchengetedzwa kwezvinodhaka uye kusimudzira chiito, zvakatenderedza nyaya dzakatanhamara dzeruzhinji kune veruzhinji, pamusoro pekukanganisa uye kushaya simba kwehurongwa hwekurapa mudziyo wekudzora uye kuvaka hunyanzvi, kuitira kuti vabatanidze zvizere mhedzisiro yekugadziriswa kwakakosha uye nekushingairira kusimudzira kushanda kwekutonga kwekusungwa, matanho anoshanda, sitiroko inoshanda, uye kutsvaga mhedzisiro inobatika, kuitira kuti vanhu vave nepfungwa huru yekuwana vanhu, kuitira kuti vatongi vave nepfungwa huru kubudirira, uye kuitira kuti vatori vechikamu vave nekunzwa kukuru kwekugutsikana.

Chechina, kushingaira kukurudzira kuvakwa kwehutano hwehutano hwehutano, rubatsiromudziyo wekurapakuvandudzwa kwemaindasitiri uye kusimudzira kwemhando yepamusoro.Hunhu hwechigadzirwa ndiyo nzira yehupenyu yebhizinesi.Chinokosha uye yakakosha poindi yemazuva ano yekurapa mudziyo manejimendi iri mumhando yekutonga system.Sezvo pasina kururamisira pasina kururamisira kwemaitiro, hapana chengetedzo yechigadzirwa pasina kuchengetedza system.Muhupenyu hwese hwekutenderera kwehudhivhisi yemhando yekutarisira maitiro, chero hurema hudiki hunogona kutungamira mukuputsika kwehurongwa.Hunhu system inomhanya zvakajairika, dambudziko rechigadzirwa netsaona;quality system inomhanya zvisingaite, chigadzirwa hachina dambudziko chipo.Mumunda wezvishandiso zvekurapa, zvinodikanwa kuita kuvakwa kwehutano hwekutonga system, kudzivirira njodzi nehurongwa, kuve nechokwadi chekuchengetedza nehurongwa, kusimbisa kugona kwehurongwa, kutsvaga budiriro nehurongwa.Mukusimudzira kuvakwa kwemidziyo yekurapa quality management system, tinovimba kutimudziyo wekurapaindasitiri kusangana inogona kuve nekuzvipira kukuru uye kuita.

Chechishanu, kutora chikamu nesimba mukutsinhana kwepasi rose nekushandira pamwe, batsira yepasi rose yezvokurapa mudziyo unodzora kusanganisa, kurongeka uye kuvimbana.Nyika yanhasi inyika yakavhurika.Munyori Mukuru Xi Jinping akataura kuti "kuvaka nharaunda yezvinozoitika remangwana revanhu vepasirese.""Parizvino, kuchinja kwenyika, kuchinja kwenguva uye kuchinja kwenhoroondo zviri kuitika nenzira isati yamboitika.""Tinofanirwa kuwedzera chiono chedu chepasirese, kuwana ruzivo rwakadzama pamusoro pemafambiro uye kufambira mberi kwevanhu, kupindura zvakanaka kune zvinonetsa pasi rose zvevanhu vanobva munyika dzese, kubatsira mukugadzirisa matambudziko akatarisana nevanhu, uye kutora uye kutora zvese. kubudirira kwakatanhamara kworudzi rwomunhu nendangariro yakafara inobatanidza nzizi dzose, kuti isimudzire kuvakwa kwenyika iri nani.”Kuchinjira kubudiriro yekudyidzana kwenyika dzepasi rose uye kutengeserana kusununguka, tichatora chikamu mune zvepasi rosemudziyo wekurapakuchinjana kwemitemo uye kushanda pamwe nekuona kwakafara, mafungiro akanaka uye kukurumidza kudzikama, uye kuedza kusimudzira kuwirirana, kurongeka uye kuvimbana, kuitira kuti pave nekubatana kuhutano hweveruzhinji hwepasirese nenzira. izvo zvakafanira nguva huru iyi.

Hatizovi kure namakomo nemakungwa;hatizoganhurirwi nezuva nemwedzi patinenge tichitasva pamusoro.Ramangwana rakajeka reChina indasitiri yemidziyo yekurapa iri mune ramangwana, kumberi uye pasi petsoka.Ngatishandei pamwe chete, maererano nezvinodiwa neHurumende yeDrug Administration "kutaura zvematongerwo enyika, kutarisa kwakasimba, kuchengetedza kuchengetedzwa, kukurudzira budiriro uye kubatsira hupenyu hwevanhu", kufambira mberi, kushanda nesimba, kukurumidza kusvetuka kubva munyika huru kuenda kune yakasimba. nyika mukugadziramidziyo yekurapa, uye kupa mipiro yakakura mukuchengetedza nekusimudzira hutano hweveruzhinji.

 

Hongguan chengetedza hutano hwako.

Ona zvimwe Hongguan Chigadzirwa→https://www.hgcmedical.com/products/

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Nguva yekutumira: Oct-17-2023