Nūhou

No ka nānā ʻana i nā lāʻau lapaʻau, ʻo 2020 kahi makahiki piha i nā pilikia a me nā manaʻolana. I ka makahiki i hala iho nei, ua hoʻopuka ʻia ka lehulehu o nā kulekele koʻikoʻi, ua hana ʻia nā mea nui i ka ʻae ʻana i ka pilikia, a ua hoʻokumu ʻia nā ʻano hana hou…

01 Ua hoʻonui ʻia ka wikiwiki o ka loiloi pilikia a me ka ʻae ʻana i nā mea lapaʻau i kā mākou hoʻoikaika ʻana e pale a kāohi i ka maʻi maʻi.

Ma hope o ka puka ʻana o Covid-19, ua hoʻokumu ka Center for Medical Device Evaluation of National Medical Products Administration i kahi kaʻina loiloi pilikia ma Ianuali 21. Ua komo mua ka poʻe loiloi a pane i nā pilikia 24 mau hola i ka lā e hoʻolako i nā lawelawe holomua no nā mea noi inoa no ka huahana. hoʻomohala a hoʻopaʻa inoa. Ma ka lā 26 o Ianuali, ua hoʻomaka ʻia kekahi mau mea hoʻokalakupua nucleic acid detection reagents ma Kina; i ka lā 22 o Pepeluali, ua hoʻomaka ka ʻae ʻia ʻana o nā reagents detection antibody coronavirus, a hiki i kēia mau mea ke hoʻokō i nā pono o kā mākou hoʻoikaika ʻana e hakakā i ka maʻi maʻi. Eia kekahi, ua ʻae ʻia nā mea lapaʻau ʻē aʻe i hoʻohana ʻia no ka ʻae ʻana i ka ulia pōpilikia no ke kumu o ka pale ʻana a me ka mālama ʻana i ka maʻi maʻi, e like me nā gene sequencers, ventilators, a me nā mea hoʻokalakupua nucleic acid analyzers mau.

02 Ua ʻae ʻia kekahi mau mea lapaʻau artificial intelligence no ke kūʻai aku ʻana.

I kēia makahiki, ua ʻike ʻo Kina i nā holomua nui i ka ʻae ʻana i nā mea lapaʻau artificial intelligence. I Ianuali, ua loaʻa ʻo Beijing Kunlun Medical Cloud Technology Co., Ltd. i ka palapala hoʻopaʻa inoa ʻana i ka palapala hoʻopaʻa inoa ʻana i ka papa III no kāna polokalamu helu helu fractional flow; i Pepeluali, ua kākau inoa ʻia a ʻae ʻia ka AI "ECG analysis software" o Lepu Medical; i ka mahina o Iune, ua ʻae ʻia ka polokalamu MR imaging-assisted diagnostics no nā ʻōpū intracranial ma ke ʻano he mau lāʻau lapaʻau Class III; I Iulai, ua ʻae ʻia ka AI "ECG machine" o Lepu Medical; I ʻAukake, ua ʻae ʻia ka huahana hou "Diabetic retinopathy fundus image-aided diagnostic software" i hana ʻia e Shenzhen Siji Intelligent Technology Co., Ltd. a me "Diabetic retinopathy analysis software" i hana ʻia e Shanghai Yingtong Medical Technology Co., Ltd. Ma ka lā 16 o Kekemapa, ua ʻae ʻia ka huina o 10 mau huahana lāʻau lapaʻau artificial intelligence no ka papa inoa.

03 Hoʻolaha ʻia nā mea e pili ana i ka hoʻokele ʻana i nā hoʻokolohua lapaʻau lōʻihi o nā mea lapaʻau (no ka hoʻokolokolo)

Ma Malaki 20, ua hoʻopuka pū ka National Medical Products Administration a me ka National Health Commission i nā Provisions on the Administration of Extended Clinical Trials of Medical Devices (no Trial), e ʻae ana i nā huahana i pono i ka nānā mua ʻana i ke kino akā ʻaʻole i ʻae ʻia no ke kūʻai aku. , i hoʻohana ʻia no nā maʻi maʻi koʻikoʻi i loaʻa ʻole ka lāʻau lapaʻau kūpono, ke loaʻa ka ʻae ʻike ʻia a mālama ʻia ka loiloi etika. Eia kekahi, ua ʻae ʻia ka ʻikepili palekana o nā hoʻokolohua lapaʻau lōʻihi o nā lāʻau lapaʻau e hoʻohana no ka noi inoa inoa.

04 ʻO ka huahana lāʻau lapaʻau mua o Kina e hoʻohana ana i ka ʻikepili honua maoli i ʻae ʻia no ke kūʻai aku

Ma Malaki 26, ua ʻae ka National Medical Products Administration i ke kākau inoa ʻana o ka "Glaucoma Drainage Tube" o Allergan o ʻAmelika Hui Pū ʻIa. Ke hoʻohana nei kēia huahana i nā hōʻike hōʻike hoʻomaʻamaʻa honua maoli i hōʻiliʻili ʻia ma Hainan Boao Lecheng Pioneer Area no ka loiloi ʻana i nā ʻokoʻa lāhui, a lilo i huahana home mua i ʻae ʻia ma o kēia kahawai.

05 2020 ʻO ka hoʻopaʻa ʻana i nā mea hoʻopaʻi ma ka pūnaewele no nā mea lapaʻau i hoʻopuka ʻia e ka National Medical Products Administration.

Ma ʻApelila 29, ua hoʻopuka ka National Medical Products Administration i ka 2020 "Hunting Convicts Online Initiative" no nā Mea Lapaʻau, e koi ana e alakaʻi ʻia ka hana "ma ka pūnaewele" a me ka "offline" a pono e hoʻohui ʻia ka ʻike a me ka huahana. Ua hoʻokūpaʻa pū ka manaʻo i ka paepae ʻaoʻao ʻekolu no nā lawelawe kālepa lāʻau lapaʻau pūnaewele e pono ke kuleana no ka hoʻokele ʻana i ia mau hana a ʻo ke kuleana nui e waiho ʻia me nā ʻoihana kūʻai pūnaewele no nā mea lapaʻau. ʻO nā keʻena hoʻoponopono lāʻau lapaʻau ke kuleana no ka nānā ʻana i nā mea hana i kūʻai ʻia i loko o ko lākou ʻāina, e hoʻoikaika ʻia ka nānā ʻana i nā ʻoihana lapaʻau ma ka pūnaewele, a e paʻi nui ʻia nā hewa o nā kānāwai a me nā lula.

06 Pilot Work Unique Device Identification (UDI) System Ke holomua mau nei

Ma Iulai 24, ua mālama ka National Medical Products Administration i kahi hālāwai no ka paipai ʻana i ka hana hoʻokele o ka ʻōnaehana hōʻike manaʻo kū hoʻokahi (UDI), hōʻuluʻulu i kēlā me kēia manawa i ka holomua a me ka pono o ka hana hoʻokele no ka ʻōnaehana UDI, a hoʻomaʻamaʻa i ka hoʻomohala hohonu o ka mea hoʻokele. hana. Ma Kepakemapa 29, ua hoʻopuka pū ka National Medical Products Administration, National Health Commission a me ka National Healthcare Security Administration i kahi palapala e hoʻolōʻihi i ka manawa hoʻokele o ka ʻōnaehana UDI no nā mea lapaʻau a hiki i Dekemaba 31, 2020. a me 69 mau ʻano o nā lāʻau lapaʻau papa III e hoʻokō ʻia ma Ianuali 1, 2021.

07 Pilot Application of Electronic Registration Certificate for Medical Devices by National Medical Products Administration

Ma ʻOkakopa 19, ua hoʻopuka ka National Medical Products Administration i ka Hoʻolaha no ka Pilot Application of Electronic Registration Certificate for Medical Devices, a ua hoʻoholo e hoʻopuka i nā palapala hoʻopaʻa inoa uila no nā mea lapaʻau ma ke kumu hoʻokele e hoʻomaka ana mai ʻOkakopa 19, 2020. ʻOkakopa 19, 2020 a hiki i ʻAukake 31, 2021. ʻO ke ʻano o nā lāʻau lapaʻau i kūpono e loaʻa i ia mau palapala hōʻoia e pili ana i nā lāʻau lapaʻau home Class III a me nā lāʻau lapaʻau Class II a me III i hoʻopaʻa inoa mua ʻia. E hoʻopuka lohi ʻia nā palapala hōʻoia no ka hoʻololi a me ka hoʻopaʻa inoa ʻana ma muli o ke kūlana maoli.

08 Hoʻopaʻa ʻia ka wiki hoʻolaha palekana palekana o ka Lapaʻau Lapaʻau

Mai ʻOkakopa 19 a hiki i ka 25, ua mālama ʻia ka National Medical Products Administration i ka First National Medical Device Safety Promotion Week ma kahi ākea ākea. Hoʻokumu ʻia ma ka "hoʻolaha ʻana i ke kumumanaʻo nui o ka hoʻoponopono a me ka hana hou a me ka hoʻomaikaʻi ʻana i nā mea hoʻokele hou o ka hoʻomohala ʻana i ka ʻoihana", ua pili ka hanana i kahi kumu koi a me ka pilikia, a ua hoʻokō i kāna mau hana hoʻolaha ma nā ʻano he nui. I ka wā o ka hanana, ua hana like nā keʻena hoʻoponopono lāʻau lapaʻau ma nā ʻano like ʻole a hoʻonui i ka ʻike o ka lehulehu e pili ana i nā mea lapaʻau ma o ka mālama ʻana i nā ʻano hana like ʻole.

09 Nā alakaʻi alakaʻi ʻenehana no ka hoʻohana ʻana i ka ʻikepili o ka honua maoli no nā loiloi hōʻoia o nā mea lapaʻau (no ka hoʻāʻo) i hoʻolaha ʻia.

Ma ka lā 26 o Nowemapa, ua hoʻopuka ka National Medical Products Administration i ka Technical Guidelines for Use Real-World Data for the Clinical Evaluations of Medical Devices (no Trial) e wehewehe ana i nā manaʻo koʻikoʻi e like me ka ʻikepili honua maoli, ka noiʻi honua maoli, a me nā hōʻike honua maoli. Hāʻawi ke alakaʻi i nā kūlana maʻamau 11 e hoʻohana ʻia ai nā hōʻike maoli i ka loiloi loiloi o nā mea lapaʻau a wehewehe i ke ala o ka ʻikepili honua maoli i hoʻohana ʻia i ka loiloi lapaʻau o nā mea lapaʻau, pēlā e hoʻonui ai i nā kumu o ka ʻikepili lapaʻau.

10 Ua hoʻonohonoho ʻia ka National Food and Drug Administration e hoʻoikaika i ka nānā ʻana i ka maikaʻi o nā Stents Coronary i koho ʻia ma ke kūʻai ʻana i waena.

I Nowemapa, ua hoʻonohonoho ka moku'āina i ke kūʻai kikowaena o nā stents coronary. Ma ka lā 11 o Nowemapa, ua hoʻopuka ka National Medical Products Administration i kahi leka e hoʻoikaika ai i ka nānā ʻana i ka maikaʻi o nā stents coronary i koho ʻia i ke kūʻai ʻana i ke kikowaena kūloko; Ma ka lā 25 o Nowemapa, ua hoʻonohonoho ka National Medical Products Administration i kahi hālāwai kūkā wikiō e pili ana i ka maikaʻi a me ka mālama palekana o nā stents coronary i koho ʻia ma ke kūʻai ʻana i ke kikowaena kūloko e piʻi i ka maikaʻi a me ka mālama palekana o nā huahana i koho ʻia; Ma ka lā 10 o Kekemapa, ua alakaʻi ʻo Xu Jinghe, ka hope luna o ka National Medical Products Administration, i kahi hui kiaʻi a me ka hui hoʻokolokolo e noiʻi i ka hoʻokele maikaʻi ʻana o nā mea hana stent coronary i koho ʻia ma Beijing.

Source: Hui Kina no ka ʻoihana lāʻau lapaʻau