Amakuru

Kugenzura ibikoresho byubuvuzi, 2020 ni umwaka wuzuye ibibazo nibyiringiro.Umwaka ushize, hashyizweho politiki zingenzi zagiye zisimburana, intambwe igaragara yatewe mu byemezo byihutirwa, kandi havutse udushya twinshi… Reka dusubize amaso inyuma ku rugendo rwacu rudasanzwe mu kugenzura ibikoresho by’ubuvuzi muri 2020.

01 Umuvuduko wo gusuzuma no kwemeza ibikoresho byubuvuzi byihuse mubikorwa byacu byo gukumira no kurwanya icyorezo.

Nyuma y’icyorezo cya Covid-19, Ikigo gishinzwe gusuzuma ibikoresho by’ubuvuzi cy’ikigo cy’igihugu gishinzwe ubuvuzi cyatangije uburyo bwihuse bwo gusuzuma byihutirwa ku ya 21 Mutarama. iterambere no kwiyandikisha.Ku ya 26 Mutarama, reagent zimwe na zimwe za coronavirus nucleic aside zitangira kwemezwa mu Bushinwa;ku ya 22 Gashyantare, reagent ya antibody ya coronavirus yatangiye kwemezwa, kandi izo miti zirashobora guhaza imbaraga zacu zo kurwanya iki cyorezo.Byongeye kandi, ibindi bikoresho byubuvuzi bikoreshwa mu kwemererwa byihutirwa hagamijwe gukumira no kurwanya icyorezo, urugero nka gene ikurikirana, guhumeka, hamwe n’ubushakashatsi buri gihe bwo kongera ubushyuhe bwa nucleic aside.

02 Ibikoresho byinshi byubuvuzi byubwenge byemewe byo kwamamaza.

Uyu mwaka, Ubushinwa bwabonye intambwe nini mu kwemeza ibikoresho byubuvuzi byubwenge.Muri Mutarama, Beijing Kunlun Medical Cloud Technology Co., Ltd. yabonye icyiciro cya mbere cyubwenge bwa artile icyiciro cya gatatu cyo kwandikisha ibikoresho byubuvuzi kubice bya software byabitswe;muri Gashyantare, AI “ECG isesengura software” ya Lepu Medical yanditswe kandi iremezwa;muri kamena, porogaramu ya MR ifashwa no gusuzuma ibibyimba byo mu nda byemewe nkibikoresho byubuvuzi byo mu cyiciro cya III;Muri Nyakanga, AI “ECG imashini” ya Lepu Medical yaremewe;Muri Kanama, ibicuruzwa bishya byitwa "Diabetic retinopathie fundus image-aided software software" byakozwe na Shenzhen Siji Intelligent Technology Co., Ltd. hamwe na "Diabetic retinopathy analysis software" byakozwe na Shanghai Yingtong Medical Technology Co., Ltd byemejwe kurutonde.Kugeza ku ya 16 Ukuboza, ibicuruzwa 10 byifashishwa mu buhanga by’ubuvuzi byemejwe kurutonde.

03 Ingingo zerekeye Ubuyobozi bwagutse bwagutse bwibikoresho byubuvuzi (kubigerageza) Byatangajwe

Ku ya 20 Werurwe, Ikigo cy’igihugu gishinzwe ubuvuzi hamwe na komisiyo y’ubuzima y’igihugu basohoye ingingo zerekeye imiyoborere y’ikigereranyo cyagutse cy’ibikoresho by’ubuvuzi (kubigerageza), cyemerera ibicuruzwa bifite akamaro mu kwitegereza kwa mbere ariko bikaba bitemewe ko byamamaza , gukoreshwa kubarwayi barembye cyane badafite imiti ifatika, mugihe habonetse uruhushya rubimenyeshejwe kandi hagakorwa isuzuma ryimyitwarire.Byongeye kandi, amakuru yumutekano yikigereranyo cyagutse cyibikoresho byubuvuzi biremewe gukoreshwa mugusaba kwiyandikisha.

04 Ibicuruzwa byambere byubuvuzi byubushinwa ukoresheje amakuru yimbere mu gihugu yemewe yo kwamamaza

Ku ya 26 Werurwe, Ikigo cy’igihugu gishinzwe ubuvuzi cyemeje iyandikwa rya “Glaucoma Drainage Tube” ya Allergan yo muri Amerika.Iki gicuruzwa gikoresha ibimenyetso bifatika byakusanyirijwe mu gace ka Hainan Boao Lecheng Pioneer kugirango hasuzumwe itandukaniro ry’amoko, bibe ibicuruzwa byambere mu gihugu byemejwe binyuze kuri uyu muyoboro.

05 2020 Guhiga Abakatiwe Gutangiza Ibikoresho Byubuvuzi Byatanzwe nubuyobozi bwigihugu gishinzwe ubuvuzi

Ku ya 29 Mata, Ikigo cy’igihugu gishinzwe ubuvuzi cyasohoye 2020 “Guhiga abakatiwe ku rubuga rwa interineti” ku bikoresho by’ubuvuzi, bisaba ko iki gikorwa kigomba gukorwa “kuri interineti” na “kuri interineti” kandi amakuru n'ibicuruzwa bigomba guhuzwa.Iyi gahunda yashimangiye kandi ko urubuga rw’abandi bantu batanga serivisi z’ubuvuzi ku rubuga rwa interineti rugomba kubiryozwa mu gucunga ibyo bikorwa kandi inshingano nyamukuru igomba kuba ku bigo bigurisha kuri interineti ibikoresho by’ubuvuzi.Inzego zishinzwe kugenzura ibiyobyabwenge zishinzwe kugenzura ibikoresho bigurishwa mu karere kabo, kugenzura ibikorwa by’ubuvuzi kuri interineti bigomba gukaza umurego, kandi kurenga ku mategeko n'amabwiriza bigomba gutangazwa cyane.

06 Umudereva Akazi Kumenyekanisha Ibikoresho Byihariye (UDI) Sisitemu Itezimbere

Ku ya 24 Nyakanga, Ikigo cy’igihugu gishinzwe ubuvuzi cyakoze inama yo guteza imbere umurimo w’icyitegererezo wa sisitemu yihariye imenyekanisha ibikoresho (UDI), mu ncamake incamake aho ibikorwa bigeragezwa bigerwaho na sisitemu ya UDI, kandi byorohereza iterambere ryimbitse ry’umuderevu. akazi.Ku ya 29 Nzeri, Ikigo cy’igihugu gishinzwe ubuvuzi, komisiyo y’ubuzima n’ikigo cy’igihugu gishinzwe umutekano w’ubuzima bafatanije inyandiko yo kongera igihe cy’icyitegererezo cya sisitemu ya UDI y’ibikoresho by’ubuvuzi kugeza ku ya 31 Ukuboza 2020. Kwagura icyiciro cya mbere cy’ibyiciro 9 nubwoko 69 bwibikoresho byubuvuzi byo mu cyiciro cya III bizashyirwa mubikorwa ku ya 1 Mutarama 2021.

07 Icyitegererezo cyo Kwiyandikisha kuri elegitoroniki Icyemezo cyibikoresho byubuvuzi nubuyobozi bwibicuruzwa byubuvuzi

Ku ya 19 Ukwakira, Ikigo cy’igihugu gishinzwe ubuvuzi cyasohoye Itangazo ryerekeye gusaba Pilote icyemezo cy’iyandikisha rya elegitoroniki ku bikoresho by’ubuvuzi, maze rifata icyemezo cyo gutanga ibyemezo bya elegitoroniki by’ibikoresho by’ubuvuzi ku buryo bw'icyitegererezo guhera ku ya 19 Ukwakira 2020. Igihe cy’icyitegererezo kizatangira guhera Ku ya 19 Ukwakira 2020 kugeza ku ya 31 Kanama 2021. Ingano y’ibikoresho by’ubuvuzi byujuje ibyangombwa birimo ibikoresho by’ubuvuzi byo mu cyiciro cya III hamwe n’ibikoresho by’ubuvuzi byo mu cyiciro cya II na III byinjijwe bwa mbere.Icyemezo cyo guhindura no kuvugurura kwiyandikisha kizatangwa buhoro buhoro ukurikije uko ibintu bimeze.

08 Icyumweru cya mbere cyubuvuzi bwibikoresho byubuvuzi byateguwe

Kuva ku ya 19 kugeza ku ya 25 Ukwakira, Ikigo cy’igihugu gishinzwe ubuvuzi cyakoze icyumweru cya mbere cy’ubuvuzi bw’ibikoresho by’ubuvuzi ku rwego rw’igihugu.Yibanze ku “guteza imbere insanganyamatsiko nyamukuru yo kuvugurura no guhanga udushya no guteza imbere abashoramari bashya mu iterambere ry’inganda”, ibirori byubahirije ihame rishingiye ku byifuzo kandi bishingiye ku bibazo, kandi ryashyize ingufu mu kumenyekanisha ibintu byinshi.Muri ibyo birori, ishami rishinzwe kugenzura ibiyobyabwenge mu nzego zinyuranye ryakoranye kandi ryongerera ubumenyi abaturage ibijyanye n’ubuvuzi bakora ibikorwa bitandukanye.

09 Amabwiriza ya tekiniki yo gukoresha amakuru nyayo-yisi yo gusuzuma ivuriro ryibikoresho byubuvuzi (kubigerageza) Byatangajwe

Ku ya 26 Ugushyingo, Ikigo cy’igihugu gishinzwe ubuvuzi cyasohoye Amabwiriza ya Tekiniki yo gukoresha amakuru nyayo y’isi kugira ngo asuzume ivuriro ry’ibikoresho by’ubuvuzi (kubigerageza) asobanura imyumvire yingenzi nkamakuru yisi, ubushakashatsi bwukuri ku isi, nibimenyetso bifatika ku isi.Amabwiriza yerekanaga ibihe 11 bisanzwe aho ibimenyetso bifatika bikoreshwa mugusuzuma ivuriro ryibikoresho byubuvuzi kandi bigasobanura inzira yamakuru nyayo akoreshwa mugusuzuma ivuriro ryibikoresho byubuvuzi, bityo bikagura amasoko yamakuru yubuvuzi.

10 Ikigo cy’igihugu gishinzwe ibiryo n’ibiyobyabwenge cyateguye gushimangira igenzura ryiza rya Coronary Stents zatoranijwe mu masoko yo hagati

Mu Gushyingo, leta yateguye amasoko yibanze ya coronary stent.Ku ya 11 Ugushyingo, Ikigo cy’igihugu gishinzwe ubuvuzi cyasohoye itangazo ryo gushimangira igenzura ry’ubuziranenge bw’imitsi yatoranijwe mu masoko y’igihugu;Ku ya 25 Ugushyingo, Ikigo cy’igihugu cy’ubuvuzi cyateguye kandi gitumiza inama ya videwo ku bijyanye n’ubuziranenge n’umutekano bigenzurwa na coronariyeri zatoranijwe mu masoko y’igihugu hagamijwe kongera ubuziranenge n’umutekano ku bicuruzwa byatoranijwe;Ku ya 10 Ukuboza, Xu Jinghe, umuyobozi wungirije w'ikigo cy’igihugu gishinzwe ubuvuzi, yayoboye itsinda ry’ubugenzuzi n’iperereza kugira ngo bakore iperereza ku micungire y’umusaruro w’ibicuruzwa bibiri byatoranijwe bikorerwa i Beijing.

Inkomoko: Ishyirahamwe ryubushinwa kubikoresho byubuvuzi