Amakuru

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

01 Umuvuduko wo gusuzuma no kwemeza ibikoresho byubuvuzi wihuse 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 bwo gusuzuma byihutirwa ku ya 21 Mutarama. Abasesenguzi batabaye mbere kandi basubiza ibibazo byihutirwa amasaha 24 kuri 24 kugira ngo batange serivisi zinoze ku basaba kwiyandikisha ku bicuruzwa iterambere no kwiyandikisha.Ku ya 26 Mutarama, reagent zimwe na zimwe za coronavirus nucleic aside zerekana ko zatangiye kwemezwa mu Bushinwa;ku ya 22 Gashyantare, reagent ya antibody ya coronavirus yatangiye kwemezwa, kandi abo bakozi barashobora guhaza imbaraga zacu zo kurwanya iki cyorezo.Byongeye kandi, ibindi bikoresho byubuvuzi bikoreshwa mu kwemererwa byihutirwa hagamijwe gukumira no kurwanya icyorezo cy’icyorezo, urugero nka gene zikurikirana, umuyaga uhumeka, hamwe n’ubushakashatsi buri gihe bwo kongera ubushyuhe bwa nucleic aside isesengura.

02 Ibikoresho byinshi byubuvuzi byubwenge byemewe byo kwamamaza.

Uyu mwaka, Ubushinwa bwabonye intambwe nini mu kwemeza ibikoresho by’ubuvuzi by’ubukorikori.Muri Mutarama, Beijing Kunlun Medical Cloud Technology Co., Ltd. yabonye icyemezo cya mbere cyubwenge bwa artile icyiciro cya III icyemezo cyo kwandikisha ibikoresho byubuvuzi kubice bya software byabitswe;muri Gashyantare, AI “ECG isesengura software” ya Lepu Medical yanditswe kandi iremezwa;muri kamena, porogaramu yo gusuzuma MR ifashwa no gusuzuma ibibyimba byo mu nda byemewe nkibikoresho byubuvuzi byo mu cyiciro cya III;Mukakaro, AI “ECG mashini” yubuvuzi bwa Lepu yemejwe;Muri Kanama, ibicuruzwa bishya “Diabete retinopathie fundus ishusho-ifasha gusuzuma indwara” byakozwe na Shenzhen Siji Intelligent Technology Co., Ltd na “Diabete retinopathie software software” byakozwe na Shanghai Yingtong Medical Technology Co., Ltd. byemejwe ko byashyizwe ku rutonde.Kugeza ku ya 16 Ukuboza, ibicuruzwa 10 by’ubukorikori by’ubuvuzi byemejwe ko byashyizwe ku rutonde.

03 Ingingo zerekeye imiyoborere yikigereranyo cyagutse cyibikoresho byubuvuzi (kubigerageza) Byatangajwe

Ku ya 20 Werurwe, Ikigo cy’igihugu gishinzwe ibicuruzwa by’ubuvuzi na komisiyo y’igihugu y’ubuzima basohoye hamwe ingingo zerekeye imiyoborere y’ibizamini by’ubuvuzi byagutse by’ibikoresho by’ubuvuzi (kubigerageza), byemerera ibicuruzwa bifite akamaro mu bushakashatsi bw’amavuriro ariko bikaba bitaremezwa ko byamamaza , gukoreshwa kubarwayi barembye cyane badafite ubuvuzi bunoze, hashingiwe ko habonetse uruhushya rubimenyeshejwe kandi hagakorwa isuzuma ryimyitwarire.Byongeye kandi, amakuru yumutekano yikigereranyo cyagutse cyibikoresho byubuvuzi yemerewe gukoreshwa mugusaba kwiyandikisha.

04 Ubushinwa bwa mbere ibikoresho byubuvuzi ukoresheje amakuru yimbere mu gihugu yemewe yo kwamamaza

Ku ya 26 Werurwe, Ikigo cy’igihugu gishinzwe ibicuruzwa by’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, bibaye ibicuruzwa byambere mu gihugu byemejwe binyuze kuri uyu muyoboro.

05 2020 Abahiga Bakatiwe Kumurongo Wibikoresho byubuvuzi Byatanzwe nubuyobozi bwigihugu bwibicuruzwa byubuvuzi

Ku ya 29 Mata, Ikigo cy’igihugu cy’ibicuruzwa by’ubuvuzi cyasohoye 2020 “Guhiga abakatiwe ku rubuga rwa interineti” ku bikoresho by’ubuvuzi, bisaba ko iki gikorwa kigomba gukorwa haba “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 y'ibanze igomba kuba ku bigo bigurisha kuri interineti ku bikoresho by’ubuvuzi.Ishami rishinzwe kugenzura ibiyobyabwenge rishinzwe kugenzura ibikoresho bigurishwa mu karere kabo, kugenzura ibikoresho by’ubuvuzi kuri interineti bigomba gukaza umurego, kandi kurenga ku mategeko n'amabwiriza bigomba gutangazwa cyane.

06 Umupilote Akazi Kumenyekanisha Ibikoresho Byihariye (UDI) Sisitemu Itezimbere

Ku ya 24 Nyakanga, Ikigo cy’igihugu cy’ibicuruzwa by’ubuvuzi cyakoze inama yo guteza imbere umurimo w’icyitegererezo wa sisitemu idasanzwe imenyekanisha ibikoresho (UDI), mu ncamake incamake aho iterambere n’ingirakamaro by’imirimo y’icyitegererezo kuri 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. Kongera icyiciro cya mbere cy’ibyiciro 9 nubwoko 69 bwibikoresho byubuvuzi byo mu cyiciro cya III bizashyirwa mubikorwa ku ya 1 Mutarama 2021.

07 Icyifuzo cyo gutwara indege Icyemezo cyo kwiyandikisha kuri elegitoronike kubikoresho byubuvuzi nubuyobozi bwibicuruzwa byubuvuzi byigihugu

Ku ya 19 Ukwakira, Ikigo cy’igihugu cy’ibicuruzwa by’ubuvuzi cyasohoye Itangazo ryerekeye gusaba gutwara indege icyemezo cy’iyandikisha rya elegitoroniki ku bikoresho by’ubuvuzi, maze rifata icyemezo cyo gutanga ibyemezo by’iyandikisha rya elegitoroniki ku bikoresho 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. Umubare w’ibikoresho by’ubuvuzi byujuje ibisabwa kugira ngo ubone izo mpamyabumenyi birimo ibikoresho by’ubuvuzi byo mu cyiciro cya III ndetse n’ibikoresho by’ubuvuzi byo mu cyiciro cya II na III byinjijwe bwa mbere byanditswe.Impamyabumenyi zo guhindura no kuvugurura kwiyandikisha zizatangwa buhoro buhoro bitewe nukuri.

08 Icyumweru cya mbere cyigihugu cyo kuvura ibikoresho byo guteza imbere umutekano

Kuva ku ya 19 kugeza ku ya 25 Ukwakira, Ikigo cy’igihugu gishinzwe ubuvuzi cyakoze icyumweru cya mbere cy’igihugu gishinzwe guteza imbere umutekano w’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”, iki gikorwa cyubahirije ihame rishingiye ku byifuzo kandi rishingiye ku bibazo, kandi ryashyize ingufu mu kumenyekanisha ibintu muri byinshi.Muri ibyo birori, ishami rishinzwe kugenzura ibiyobyabwenge mu nzego zitandukanye ryakoranye kandi ryongera ubumenyi bw’abaturage ku bikoresho by’ubuvuzi bakora ibikorwa bitandukanye.

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

Ku ya 26 Ugushyingo, Ikigo cy’igihugu gishinzwe ubuvuzi cyasohoye Amabwiriza ya Tekiniki yo gukoresha amakuru nyayo ku isi kugira ngo hasuzumwe ivuriro ry’ibikoresho by’ubuvuzi (ku igeragezwa) risobanura ibitekerezo byingenzi nkamakuru y’isi, ubushakashatsi nyabwo ku isi, hamwe n’ibimenyetso bifatika ku isi.Amabwiriza yerekanaga ibihe 11 bisanzwe aho ibimenyetso bifatika bikoreshwa mugusuzuma ivuriro ryibikoresho byubuvuzi kandi bigasobanura inzira yamakuru nyayo yakoreshejwe mugusuzuma ivuriro ryibikoresho byubuvuzi, bityo bikagura amasoko yamakuru yubuvuzi.

10 Ikigo cy’igihugu gishinzwe ibiribwa n’ibiyobyabwenge cyateguye gushimangira igenzura ry’ubuziranenge bwa Coronary Stents zatoranijwe mu masoko yo hagati

Ugushyingo, 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’ibicuruzwa by’ubuvuzi cyateguye kandi gitumiza inama ya videwo ku bijyanye n’ubuziranenge n’umutekano bigenzura ibicuruzwa byatoranijwe mu masoko y’igihugu mu rwego rwo kurushaho kunoza ubuziranenge n’umutekano ku bicuruzwa byatoranijwe;Ku ya 10 Ukuboza, Xu Jinghe, umuyobozi wungirije w'ikigo cy’igihugu gishinzwe ibicuruzwa by’ubuvuzi, yayoboye itsinda ry’ubugenzuzi n’iperereza kugira ngo hakorwe iperereza ku micungire y’umusaruro w’ibicuruzwa bibiri byatoranijwe bikorerwa mu mujyi wa Beijing.

Inkomoko: Ishyirahamwe ryubushinwa kubikoresho byubuvuzi