Kusukela zingama-31 kuMfumfu kuya kumhla lu-1 kuNovemba 2023, Ingqungquthela Yesibili Yomhlaba Wonke Yocwaningo Lwezemithi ye-Boao Yezemithi Nedivayisi yabanjwa ngempumelelo e-Boao, e-Hainan.Ngendikimba ethi “I-International Real-World Data Research and Scientific Development of Pharmaceutical and Device Regulation”, ingqungquthela ihlanganise iseshini yomhlangano kanye nezinkundla ezincane eziyisishiyagalombili ezifanayo zocwaningo lwedatha yomhlaba wangempela kanye nokulawulwa kwezidakamizwa, ukulawulwa kwemishini yezokwelapha, kanye nokulawulwa imithi yendabuko yamaShayina.
Kusukela ngo-2018, i-Medical Device Technical Review Center ye-State Drug Administration (kamuva ebizwa ngokuthi Isikhungo) yenze ucwaningo lwedatha yomhlaba wangempela emkhakheni wemishini yezokwelapha, yahamba indlela yokusebenzisa ubufakazi bomhlaba wangempela ukusiza emitholampilo. ukuhlola, kanye nokukhuthaza ukugunyazwa nokudayiswa kwenani lemishini yezokwelapha edingeka ngokushesha evela kwamanye amazwe.2021 NgoMeyi 2021, Isikhungo sahola ucwaningo lwe-International Medical Devices Regulators' Forum (IMDRF) ngoMeyi 2021, i-IMDRF eholwa yi-IMDRF. Ucwaningo oluthi "Post-market Clinical Follow-up of Medical Devices" lukhishwe, luphakamisa izidingo emithonjeni yedatha, ukuhlolwa kwekhwalithi, umklamo wocwaningo nokuhlaziywa kwezibalo ukuze kusetshenziswe idatha yomhlaba wangempela ezifundweni zokulandelela zomtholampilo zangemva kwemakethe, kanye ukuhola ekwethuleni idatha yomhlaba wangempela emibhalweni yokudidiyela yamazwe ngamazwe ye-IMDRF.Lesi sikhungo siphinde sahamba phambili ekwenzeni imibhalo eminingi yokuxhumana yamazwe ngamazwe ekuhlolweni komtholampilo kanye nokuwaguqula abe imibhalo yezimiso zobuchwepheshe e-China, ekuqaleni sakhe uhlelo lwezimiso ezijwayelekile eziyisiqondiso sokuhlolwa komtholampilo kwemishini yezokwelapha.Isikhungo siqhubekile nokukhuthaza ukusetshenziswa kobufakazi bomhlaba wangempela bokubhaliswa komkhiqizo, kube nemiphumela emangalisayo.Kuze kube manje, amaqoqo amabili ezinhlobonhlobo ezingu-13 afakiwe ekusetshenzisweni kokuhlola kwedatha yomhlaba wangempela yemishini yezokwelapha, lapho izinhlobo eziyisikhombisa ezinesamba semikhiqizo eyisishiyagalolunye zigunyazwe ukumakethwa.
Ngezinhlobo eziningi zokuhlola ezigunyazwe ukumakethwa, Isikhungo sihlola ukusetshenziswa kwedatha yomhlaba wangempela yamadivayisi ezokwelapha njalo.Ngo-Ephreli kulo nyaka, iCentre for Instrumental Review, kanye ne-Hainan Provincial Drug Administration kanye nokuphathwa kwe-Hainan Boao LeCheng International Medical Tourism Advance Zone, ngokuhlanganyela bakhiphe “Izinyathelo Zokuqaliswa Kokusetshenziswa Kwedatha Yomtholampilo Yangempela Yezwe Lokusebenza Kwemishini Yezokwelapha. e-Hainan Boao LeCheng I-International Medical Tourism Advance Zone (yokusebenzisa Isivivinyo)”.Njengamanje, izinhlobo eziyisishiyagalolunye sezingene ngokusemthethweni esiteshini sangaphambi kokuxhumana.
Ngokuzayo, Isikhungo Sokubuyekeza Insimbi sizogqugquzela ucwaningo nokusetshenziswa kwedatha yomhlaba wangempela ngaphansi kohlaka lokwakha inguqulo yesistimu yokubuyekeza yesimanje 2.0, futhi sithuthukise indima yobufakazi bomhlaba wangempela ekuhlolweni kwemishini yezokwelapha, ikakhulukazi. imikhiqizo enobungozi obukhulu kanye nemikhiqizo emisha.
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Isikhathi sokuthumela: Nov-16-2023