Xov xwm

Rau kev saib xyuas cov cuab yeej kho mob, 2020 yog ib xyoos uas muaj kev sib tw thiab kev cia siab. Xyoo dhau los, muaj ntau txoj cai tseem ceeb tau tshaj tawm ua ntu zus, muaj kev cuam tshuam tseem ceeb hauv kev pom zoo thaum muaj xwm txheej ceev, thiab ntau yam kev tsim kho tshiab tau los ua… Cia peb rov qab los ua ke ntawm peb txoj kev taug kev txawv txawv hauv kev saib xyuas cov cuab yeej kho mob xyoo 2020.

01 Kev tshuaj xyuas xwm txheej ceev thiab kev pom zoo ntawm cov cuab yeej kho mob tau nrawm dua hauv peb txoj kev siv zog los tiv thaiv thiab tswj kev sib kis.

Tom qab muaj kev sib kis ntawm Covid-19, Lub Tsev Haujlwm Saib Xyuas Kev Kho Mob Ntsuas ntawm National Medical Products Administration tau tshaj tawm cov txheej txheem tshuaj xyuas xwm txheej thaum Lub Ib Hlis 21. Cov neeg tshuaj xyuas tau cuam tshuam ua ntej thiab teb rau cov xwm txheej kub ntxhov 24 teev hauv ib hnub los muab cov kev pabcuam siab tshaj rau cov neeg thov npe rau cov khoom. kev loj hlob thiab kev sau npe. Thaum Lub Ib Hlis 26, qee qhov kuaj pom tus mob coronavirus nucleic acid reagents tau pib pom zoo hauv Suav teb; Thaum Lub Ob Hlis 22, cov tshuaj tiv thaiv kab mob coronavirus tau pib pom zoo, thiab cov neeg ua haujlwm no tuaj yeem ua tau raws li qhov xav tau ntawm peb cov kev siv zog los tawm tsam kev sib kis. Tsis tas li ntawd, lwm yam khoom siv kho mob siv rau kev pom zoo thaum muaj xwm txheej ceev rau lub hom phiaj ntawm kev tiv thaiv kab mob kis thoob qhov txhia chaw, xws li gene sequencers, lub tshuab ua pa, thiab qhov ntsuas kub tsis tu ncua ntawm nucleic acid analyzers, kuj tau pom zoo.

02 Ntau yam khoom siv kho mob txawj ntse tau pom zoo rau kev lag luam.

Xyoo no, Tuam Tshoj tau pom kev ua tiav zoo hauv kev pom zoo ntawm cov khoom siv kho mob txawj ntse. Nyob rau lub Ib Hlis, Beijing Kunlun Medical Cloud Technology Co., Ltd. tau txais thawj chav kawm txuj ci kev txawj ntse III daim ntawv pov thawj kho mob rau nws cov khoom siv hluav taws xob feem ntau khaws cia hauv computer; Thaum Lub Ob Hlis, AI "ECG tsom xam software" ntawm Lepu Medical tau sau npe thiab pom zoo; Nyob rau lub Rau Hli, MR imaging-assisted diagnosis software rau intracranial hlav tau pom zoo raws li Class III cov cuab yeej kho mob; Thaum Lub Xya Hli, AI "ECG tshuab" ntawm Lepu Medical tau pom zoo; Thaum lub Yim Hli, cov khoom tshiab "Diabetic retinopathy fundus image-aided diagnosis software" tsim los ntawm Shenzhen Siji Intelligent Technology Co., Ltd. thiab "Diabetic retinopathy analysis software" tsim los ntawm Shanghai Yingtong Medical Technology Co., Ltd. tau pom zoo rau npe. Raws li lub Kaum Ob Hlis 16, tag nrho ntawm 10 cov khoom siv kho mob txawj ntse tau pom zoo rau npe.

03 Cov Kev Cai ntawm Kev Tswj Xyuas Kev Tshawb Fawb Txog Kev Tshawb Fawb Txog Kev Kho Mob (rau Kev sim) Tshaj Tawm

Thaum Lub Peb Hlis 20, National Medical Products Administration thiab National Health Commission tau sib koom ua ke tshaj tawm Cov Cai ntawm Kev Tswj Xyuas Kev Tshawb Fawb Txog Kev Tshawb Fawb Txog Kev Kho Mob (rau Kev sim), tso cai rau cov khoom uas muaj txiaj ntsig zoo hauv kev soj ntsuam ua ntej tab sis tseem tsis tau pom zoo rau kev lag luam. , siv rau cov neeg mob hnyav uas tsis muaj kev kho mob zoo, yog tias tau txais kev tso cai pom zoo thiab tshuaj xyuas kev coj ncaj ncees. Tsis tas li ntawd, cov ntaub ntawv kev nyab xeeb ntawm kev soj ntsuam txuas ntxiv ntawm cov cuab yeej kho mob raug tso cai siv rau daim ntawv thov sau npe.

04 Tuam Tshoj thawj cov khoom siv kho mob siv cov ntaub ntawv hauv ntiaj teb tiag tiag pom zoo rau kev lag luam

Thaum Lub Peb Hlis 26, National Medical Products Administration tau pom zoo rau kev tso npe ntawm "Glaucoma Drainage Tube" ntawm Allergan ntawm Tebchaws Meskas. Cov khoom no siv cov ntaub ntawv pov thawj hauv ntiaj teb tiag tiag uas tau sau tseg hauv Hainan Boao Lecheng Pioneer Area rau kev ntsuam xyuas ntawm cov haiv neeg sib txawv, dhau los ua thawj cov khoom siv hauv tsev pom zoo los ntawm cov channel no.

05 2020 Hunting Convicts Online Initiative for Medical Devices Tshaj tawm los ntawm National Medical Products Administration

Thaum Lub Plaub Hlis 29, National Medical Products Administration tau tshaj tawm 2020 "Tshaj Tawm Cov Neeg Txhaum Cai Hauv Online" rau Cov Khoom Siv Kho Mob, uas xav kom cov thawj coj yuav tsum tau ua ob qho tib si "online" thiab "offline" thiab cov ntaub ntawv thiab cov khoom yuav tsum tau ua ke. Lub tswv yim tseem tau hais ntxiv tias cov neeg sab nrauv platform rau kev pabcuam kev kho mob hauv online yuav tsum muaj lub luag haujlwm rau kev tswj cov kev lag luam thiab lub luag haujlwm tseem ceeb yuav tsum dag nrog cov lag luam muag online rau cov khoom siv kho mob. Lub tuam tsev tswj hwm tshuaj yuav tsum muaj lub luag haujlwm saib xyuas cov cuab yeej muag hauv lawv thaj chaw, kev saib xyuas cov cuab yeej kho mob hauv online yuav tsum tau ua kom hnyav dua, thiab kev ua txhaum cai thiab kev cai yuav tsum tau tshaj tawm hnyav.

06 Pilot Work Unique Device Identification (UDI) System Advancing Steadily

Thaum Lub Xya Hli 24, National Medical Products Administration tau tuav lub rooj sib tham los txhawb txoj haujlwm tsav ntawm cov cim cim cim (UDI) system, ua ntu zus los qhia txog kev nce qib thiab kev ua tau zoo ntawm kev ua haujlwm rau kev ua haujlwm rau UDI, thiab pab txhawb kev loj hlob ntawm tus tsav. ua haujlwm. Thaum lub Cuaj Hlis 29, National Medical Products Administration, National Health Commission thiab National Healthcare Security Administration tau sib koom ua ke tshaj tawm cov ntaub ntawv txuas ntxiv lub sijhawm sim ntawm UDI system rau cov khoom siv kho mob mus txog rau lub Kaum Ob Hlis 31, 2020. Qhov txuas ntxiv rau thawj pawg ntawm 9 pawg. thiab 69 hom khoom siv kho mob Class III yuav raug muab coj los siv rau lub Ib Hlis 1, 2021.

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

Thaum Lub Kaum Hli 19, Lub Tsev Haujlwm Saib Xyuas Kev Kho Mob Hauv Tebchaws tau tshaj tawm Daim Ntawv Ceeb Toom Txog Kev Ua Haujlwm ntawm Daim Ntawv Teev Npe Hluav Taws Xob rau Cov Khoom Siv Kho Mob, thiab txiav txim siab muab daim ntawv pov thawj hluav taws xob rau cov khoom siv kho mob raws li kev sim pib txij lub Kaum Hli 19, 2020. Lub sijhawm tsav tsheb yuav pib txij thaum Lub Kaum Hli 19. Lub Kaum Hli 19, 2020 txog rau Lub Yim Hli 31, 2021. Cov peev txheej ntawm cov cuab yeej kho mob tsim nyog tau txais daim ntawv pov thawj xws li Class III cov cuab yeej kho mob hauv tsev thiab cov khoom siv kho mob tuaj rau Class II thiab III uas tau sau npe thawj zaug. Daim ntawv pov thawj rau kev hloov pauv thiab rov ua dua tshiab ntawm kev sau npe yuav raug muab maj mam nyob ntawm qhov xwm txheej tiag tiag.

08 Thawj Lub Tebchaws Kev Nyab Xeeb Kev Nyab Xeeb Kev Nyab Xeeb Lub Limtiam tau tuav

Los ntawm Lub Kaum Hli 19 txog 25, National Medical Products Administration tau tuav thawj Lub Tebchaws Kev Nyab Xeeb Kev Nyab Xeeb Kev Nyab Xeeb Lub Limtiam ntawm kev ntsuas thoob tebchaws. Lub hauv paus rau "txhawb lub ntsiab lus tseem ceeb ntawm kev hloov kho thiab kev tsim kho tshiab thiab txhim kho cov tsav tsheb tshiab ntawm kev tsim kho kev lag luam", qhov kev tshwm sim tau ua raws li qhov xav tau-oriented thiab teeb meem-taw qhia txoj cai, thiab ua nws txoj kev tshaj tawm rau ntau yam. Nyob rau hauv qhov kev tshwm sim, lub tuam tsev tswj xyuas tshuaj nyob rau hauv ntau yam ua hauj lwm nyob rau hauv tandem thiab txhim khu kev paub ntawm cov pej xeem txog kev kho mob cov cuab yeej los ntawm tuav ib tug ntau yam ntawm kev ua ub no.

09 Cov Lus Qhia Txog Kev Siv Cov Ntaub Ntawv Hauv Ntiaj Teb tiag tiag rau kev soj ntsuam kev soj ntsuam ntawm cov cuab yeej kho mob (rau kev sim) tshaj tawm

Thaum Lub Kaum Ib Hlis 26, National Medical Products Administration tau tshaj tawm Cov Lus Qhia Txog Kev Siv Cov Ntaub Ntawv Hauv Ntiaj Teb tiag tiag rau kev soj ntsuam kev soj ntsuam ntawm cov cuab yeej kho mob (rau kev sim) uas txhais cov ntsiab lus tseem ceeb xws li cov ntaub ntawv ntiaj teb tiag tiag, kev tshawb fawb ntiaj teb tiag tiag, thiab cov pov thawj hauv ntiaj teb tiag. Cov lus qhia tau hais txog 11 qhov xwm txheej uas muaj pov thawj hauv ntiaj teb no siv hauv kev soj ntsuam kev soj ntsuam ntawm cov cuab yeej siv kho mob thiab qhia meej txog txoj hauv kev ntawm cov ntaub ntawv hauv ntiaj teb tiag tiag siv hauv kev tshuaj ntsuam xyuas cov cuab yeej kho mob, yog li nthuav dav cov ntaub ntawv kho mob.

10 Lub Tsev Haujlwm Saib Xyuas Khoom Noj thiab Tshuaj Hauv Tebchaws tau npaj kom muaj zog saib xyuas kev noj qab haus huv ntawm Coronary Stents xaiv hauv Centralized Procurement

Thaum lub Kaum Ib Hlis, lub xeev tau teeb tsa qhov chaw nruab nrab ntawm kev yuav khoom ntawm coronary stents. Thaum Lub Kaum Ib Hlis 11, National Medical Products Administration tau tshaj tawm tsab ntawv ceeb toom los ntxiv dag zog rau kev saib xyuas zoo ntawm cov stents coronary stents nyob rau hauv lub teb chaws centralized procurement; Thaum Lub Kaum Ib Hlis 25, National Medical Products Administration tau teeb tsa thiab tau teeb tsa lub rooj sib tham video txog kev saib xyuas zoo thiab kev nyab xeeb ntawm kev xaiv coronary stents nyob rau hauv lub teb chaws centralized procurement los mus nce qhov zoo thiab kev nyab xeeb saib xyuas ntawm cov khoom xaiv; Thaum Lub Kaum Ob Hlis 10, Xu Jinghe, tus lwm thawj coj ntawm National Medical Products Administration, tau coj ib pab neeg saib xyuas thiab kev tshawb nrhiav los tshawb xyuas cov kev tswj xyuas kev tsim khoom ntawm ob qho kev xaiv coronary stent manufacturers hauv Beijing.

Source: Tuam Tshoj koom haum rau kev lag luam khoom siv kho mob