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Nkhani

Kuwona umboni weniweni wapadziko lapansi kuti uthandizire kuunika kwachipatala

Kuchokera ku 31 October mpaka 1 November 2023, 2nd Boao International Pharmaceutical and Device Real World Research Conference inachitikira bwino ku Boao, Hainan.Ndi mutu wa "International Real-World Data Research and Scientific Development of Pharmaceutical and Device Regulation", msonkhanowu unaphatikizapo zokambirana ndi mabwalo asanu ndi atatu ofanana pa kafukufuku wapadziko lonse lapansi ndi malamulo a mankhwala, kayendetsedwe ka zipangizo zachipatala, ndi malamulo a mankhwala achi China.

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Kuyambira 2018, Medical Device Technical Review Center ya State Drug Administration (yomwe tsopano imadziwika kuti Center) yachita kafukufuku wapadziko lonse lapansi pankhani ya zida zamankhwala, ikuyenda njira yogwiritsa ntchito umboni weniweni wothandiza pazachipatala. kuunikira, ndikulimbikitsa kuvomereza ndi kutsatsa kwa zida zingapo zomwe zikufunika mwachangu kuchokera kunja.2021 Mu Meyi 2021, Center idatsogolera kafukufuku wa International Medical Devices Regulators' Forum (IMDRF) pa Mu May 2021, IMDRF motsogozedwa ndi IMDRF. phunziro "Post-market Clinical Follow-up of Medical Devices" linatulutsidwa, kufotokozera zofunikira pa magwero a deta, kuunika kwa khalidwe, mapangidwe a maphunziro ndi kusanthula mawerengero kuti agwiritse ntchito deta yeniyeni mu maphunziro otsatila pambuyo pa msika, ndi kutsogolela pakubweretsa zidziwitso zenizeni zapadziko lonse lapansi muzolemba za International Coordination za IMDRF.Center idatsogolanso pakupanga zikalata zingapo zamagwirizano apadziko lonse lapansi pakuwunika kwachipatala ndikuzisintha kukhala zikalata zaukadaulo ku China, poyambilira ndikumanga dongosolo lachitsogozo chowunikira zida zamankhwala.Center ikupitilizabe kulimbikitsa kugwiritsa ntchito umboni weniweni padziko lonse lapansi pakulembetsa zinthu, ndi zotsatira zochititsa chidwi.Mpaka pano, magulu awiri a mitundu 13 aphatikizidwa poyesa kugwiritsa ntchito deta yeniyeni pazida zamankhwala, zomwe mitundu isanu ndi iwiri yokhala ndi zinthu zisanu ndi zinayi idavomerezedwa kuti igulidwe.

Pokhala ndi mitundu yambiri yoyeserera yovomerezeka kuti igulidwe, Center ikuwunika kugwiritsa ntchito zidziwitso zenizeni zapazida zamankhwala pafupipafupi.Mu Epulo chaka chino, Center for Instrumental Review, pamodzi ndi Hainan Provincial Drug Administration ndi Administration of Hainan Boao LeCheng International Medical Tourism Advance Zone, adagwirizana pamodzi "Njira Zothandizira Kukhazikitsa kwa Clinical Real-World Data Application of Medical Devices. ku Hainan Boao LeCheng International Medical Tourism Advance Zone (poyesa Kuyesa)”.Pakadali pano, mitundu isanu ndi inayi idalowa kale munjira yolumikizirana.

M'tsogolomu, bungwe la Instrument Review Center lidzalimbikitsa kufufuza ndi kugwiritsa ntchito deta yeniyeni pansi pa ndondomeko yomanga ndondomeko yamakono yowunikira 2.0, ndikupititsa patsogolo ntchito ya umboni weniweni wapadziko lonse poyesa zipangizo zamankhwala, makamaka. mankhwala omwe ali pachiwopsezo chachikulu komanso zatsopano.

 

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Nthawi yotumiza: Nov-16-2023