Mai 31 ʻOkakopa a 1 Nowemapa 2023, ua mālama maikaʻi ʻia ka 2nd Boao International Pharmaceutical and Device Real World Research Conference ma Boao, Hainan.Me ke poʻomanaʻo o "International Real-World Data Research and Scientific Development of Pharmaceutical and Device Regulation", ua komo ka ʻaha kūkā i kahi hālāwai plenary a me ʻewalu mau sub-forums e pili ana i ka noiʻi ʻikepili honua maoli a me ka hoʻoponopono lāʻau lapaʻau, hoʻoponopono lāʻau lapaʻau, a me ka hoʻoponopono o lāʻau lapaʻau Kina.
Mai ka makahiki 2018, ua hoʻokō ka Medical Device Technical Review Center o ka State Drug Administration (ma hope aku i kapa ʻia ʻo Center) i ka noiʻi ʻikepili honua maoli ma ke kahua o nā lāʻau lapaʻau, e hele ana i kahi ala e hoʻohana ai i nā hōʻike maoli o ka honua e kōkua i ka lāʻau lapaʻau. ka loiloi, a me ka paipai ʻana i ka ʻae ʻia a me ke kūʻai aku ʻana o kekahi mau lāʻau lapaʻau e koi koke ʻia i lawe ʻia mai. Ua hoʻokuʻu ʻia ke aʻo ʻana "Post-market Clinical Follow-up of Medical Devices", e noi ana i nā koi e pili ana i nā kumu ʻikepili, ka loiloi maikaʻi, ka hoʻolālā aʻo ʻana a me ka helu helu helu no ka hoʻohana ʻana i ka ʻikepili honua maoli i nā haʻawina ma hope o ka mākeke. ke alakaʻi nei i ka hoʻokomo ʻana i ka ʻikepili maoli i loko o nā palapala hoʻohui honua o ka IMDRF.Ua alakaʻi pū ka Center i ka hoʻokumu ʻana i nā palapala hoʻonohonoho honua e pili ana i ka loiloi lapaʻau a hoʻololi iā lākou i mau palapala normative ʻenehana ma Kina, i kūkulu mua i kahi ʻōnaehana o nā kumu alakaʻi maʻamau no ka loiloi lapaʻau o nā mea lapaʻau.Ua hoʻomau ka Center i ka hoʻolaha ʻana i ka hoʻohana ʻana i nā hōʻike honua maoli no ka hoʻopaʻa inoa huahana, me nā hopena kupaianaha.A hiki i kēia manawa, ua hoʻokomo ʻia nā ʻāpana ʻelua o nā ʻano he 13 i loko o ka noi pailaka o ka ʻikepili honua maoli no nā lāʻau lapaʻau, ʻehiku mau ʻano me ka huina o ʻeiwa mau huahana i ʻae ʻia no ke kūʻai aku.
Me nā ʻano pailaka hou aʻe i ʻae ʻia no ke kūʻai aku ʻana, ke ʻimi nei ka Center i ka noi ʻana o ka ʻikepili honua maoli no nā mea lapaʻau i kēlā me kēia manawa.I ʻApelila o kēia makahiki, ua hoʻopuka pū ka Center for Instrumental Review, me ka Hainan Provincial Drug Administration a me ka Administration of Hainan Boao LeCheng International Medical Tourism Advance Zone, i ka "Implementation Measures for the Implementation of Clinical Real-World Data Application of Medical Devices. ma Hainan Boao LeCheng International Medical Tourism Advance Zone (no ka hoʻokō hoʻokolokolo)”.I kēia manawa, ua komo mua nā ʻano ʻeiwa i ke ala mua o ke kamaʻilio.
I ka wā e hiki mai ana, e hoʻoikaika ikaika ka Instrument Review Center i ka noiʻi ʻana a me ka hoʻohana ʻana i ka ʻikepili honua maoli ma lalo o ke kahua o ke kūkulu ʻana i kahi ʻōnaehana loiloi hou 2.0, a hoʻomaikaʻi hou i ka hana o nā hōʻike honua maoli i ka loiloi o nā mea lapaʻau, ʻoi aku. nā huahana kiʻekiʻe a me nā huahana hou.
Manaʻo ʻo Hongguan i kou olakino.
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Inā loaʻa nā pono o nā mea lapaʻau, e ʻoluʻolu e kelepona mai iā mākou.
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Ka manawa hoʻouna: Nov-16-2023