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Su'esu'e fa'amaoniga moni i le lalolagi e fesoasoani i su'esu'ega a le falema'i

Mai le aso 31 o Oketopa i le aso 1 o Novema 2023, na fa'ataunu'uina ma le manuia le 2nd Boao International Pharmaceutical and Device Real World Research Conference i Boao, Hainan.Faatasi ai ma le autu o le "International Real-World Data Research and Scientific Development of Pharmaceutical and Device Regulation", o le konafesi na aofia ai se fonotaga faʻapitoa ma le valu faʻasalalauga faʻatasi i luga o suʻesuʻega faʻamaumauga o le lalolagi moni ma tulafono faatonutonu o vailaʻau, tulafono faatonutonu masini, ma tulafono faatonutonu o togafiti fa'aSaina masani.

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Talu mai le 2018, o le Medical Device Technical Review Center a le State Drug Administration (lea ua taʻua nei o le Nofoaga Tutotonu) na faia suʻesuʻega faʻamatalaga moni i le lalolagi i le tulaga o masini faʻafomaʻi, savalia se auala e faʻaoga ai faʻamaoniga moni o le lalolagi e fesoasoani i falemaʻi. iloiloga, ma le faalauiloaina o le faamaoniga ma le maketiina o le tele o masini faafomai faaulufale mai e manaomia vave. suʻesuʻega "Post-market Clinical Follow-up of Medical Devices" na tuʻuina atu, faʻatulagaina manaʻoga i luga o faʻamaumauga, iloiloga lelei, suʻesuʻega suʻesuʻega ma suʻesuʻega faʻafuainumera mo le faʻaogaina o faʻamatalaga moni o le lalolagi i suʻesuʻega tulitatao falemaʻi post-maketi, ma ta'imua i le fa'aofiina o fa'amatalaga moni o le lalolagi i pepa fa'amaopoopo fa'ava-o-malo a le IMDRF.O le Nofoaga Autu na taʻimua foʻi i le faʻatulagaina o le tele o faʻasalalauga faʻavaomalo pepa i luga o suʻesuʻega faʻapitoa ma suia i latou i pepa faʻapitoa faʻapitoa i Saina, muamua fausia se faiga o taʻiala taʻiala lautele mo suʻesuʻega falemaʻi o masini faʻafomaʻi.O loʻo faʻaauau pea ona faʻalauiloa e le Nofoaga Autu le faʻaogaina o faʻamaoniga moni o le lalolagi mo le resitalaina o oloa, ma iʻuga mataʻina.E oʻo mai i le taimi nei, e lua vaega o ituaiga 13 ua faʻapipiʻiina i totonu o le faʻataʻitaʻiga pailate o faʻamatalaga moni o le lalolagi mo masini faʻafomaʻi, lea e fitu ituaiga ma le aofaʻi o oloa e iva ua faʻamaonia mo le maketiina.

Faatasi ai ma le tele o ituaiga pailate ua faʻamaonia mo le maketiina, o loʻo suʻesuʻeina e le Nofoaga Autu le faʻaogaina o faʻamatalaga moni o le lalolagi mo masini faʻafomaʻi i taimi masani.Ia Aperila o le tausaga nei, na tuʻuina atu faʻatasi ai e le Center for Instrumental Review, faʻatasi ai ma le Hainan Provincial Drug Administration ma le Pulega a Hainan Boao LeCheng International Medical Tourism Advance Zone, le "Faiga Faʻatinoga mo le Faʻatinoina o Faʻamatalaga Faʻamatalaga Faʻamatalaga Moni a le Lalolagi o Mea Faʻafomaʻi. i Hainan Boao LeCheng International Medical Tourism Advance Zone (mo le Fa'atinoga o Su'ega)”.I le taimi nei, e iva ituaiga ua ulufale aloaia i le auala aʻo leʻi fesoʻotaʻi.

I le lumanaʻi, o le a faʻamalosia malosi e le Instrument Review Center le suʻesuʻega ma le faʻaogaina o faʻamatalaga moni o le lalolagi i lalo o le faʻavae o le fausiaina o se faiga toe iloilo faʻaonaponei version 2.0, ma faʻaleleia atili le matafaioi o faʻamaoniga moni-lalolagi i le iloiloga o masini faafomaʻi, aemaise lava. oloa maualuga le lamatia ma oloa fou.

 

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Taimi meli: Nov-16-2023