Kulawulo lwezixhobo zonyango, u-2020 ibingunyaka ozele yimiceli mngeni kunye namathemba.Kulo nyaka uphelileyo, intaphane yemigaqo-nkqubo ebalulekileyo iye yakhutshwa ngokulandelelanayo, impumelelo ebalulekileyo yenziwe kulwamkelo olungxamisekileyo, kunye nezinto ezintsha ezintsha eziye zavela... Makhe sijonge emva kunye kuhambo lwethu olungaqhelekanga lokongamela izixhobo zonyango ngo-2020.
01 Isantya sophononongo olungxamisekileyo kunye nokwamkelwa kwezixhobo zonyango siye sakhawuleziswa kwiinzame zethu zokuthintela nokulawula ubhubhane.
Emva kokuqhambuka kwe-Covid-19, iZiko loVavanyo lweSixhobo sezoNyango loLawulo lweeMveliso zoNyango lweSizwe liqalise inkqubo yokuphononongwa ngokungxamisekileyo ngoJanuwari 21. Abahlalutyi bangenelele kwangaphambili kwaye basabela kwiimeko ezingxamisekileyo iiyure ezingama-24 ngosuku ukubonelela ngeenkonzo eziphambili kubafaki zicelo zobhaliso kwimveliso. uphuhliso nobhaliso.NgoJanuwari 26, ezinye ii-reagents zokubona i-coronavirus nucleic acid zaqala ukuvunywa eTshayina;nge-22 kaFebruwari, i-coronavirus antibody reagents yaqala ukuvunywa, kwaye ezi arhente zinokuhlangabezana neemfuno zemizamo yethu yokulwa ubhubhane.Ukongeza, ezinye izixhobo zonyango ezisetyenziselwa imvume yongxamiseko ngeenjongo zothintelo kunye nolawulo lobhubhane, ezinje ngolandelelwano lwemfuza, ii-ventilators, kunye ne-amplification ye-nucleic acid ezihlalutya rhoqo ubushushu, nazo zamkelwe.
02 Zininzi izixhobo zonyango ezinobukrelekrele ezenziweyo ezivunyiweyo ukuba zithengiswe.
Kulo nyaka, iTshayina ibone impumelelo enkulu ekuvunyweni kwezixhobo zonyango zobukrelekrele bokwenziwa.NgoJanuwari, iBeijing Kunlun Medical Cloud Technology Co., Ltd. yafumana isatifiketi sokuqala sokubhaliswa kwesixhobo sonyango sobukrelekrele bokwenziwa kwiklasi ye-III kwi-fractional flow reserve yesoftware yokubala;ngoFebruwari, i-AI "isoftware yohlalutyo lwe-ECG" yeLepu Medical yabhaliswa kwaye yamkelwa;ngoJuni, isoftware yokuxilongwa kwe-MR ye-MR ye-intracranial tumors yamkelwe njengezixhobo zonyango lweClass III;NgoJulayi, i-AI "ECG machine" yeLepu Medical yamkelwa;Ngo-Agasti, imveliso entsha "I-Diabetic retinopathy fundus isoftware yokuxilongwa kwesifo" eveliswe nguShenzhen Siji Intelligent Technology Co., Ltd. kunye ne "Diabetic retinopathy analysis software" eveliswe yiShanghai Yingtong Medical Technology Co., Ltd. yavunywa ukuba idweliswe.Ukusukela nge-16 kaDisemba, iimveliso ezili-10 zezixhobo zonyango ezivunyiweyo zivunyiwe ukuba zidweliswe.
Izibonelelo ze-03 kuLawulo lweeMvavanyo ezongezelelweyo zeklinikhi yeZixhobo zoNyango (zoLingo) zibhengezwe.
Ngomhla we-20 ka-Matshi, uLawulo lweeMveliso zezoNyango lweSizwe kunye neKomishoni yezeMpilo yeSizwe ngokudibeneyo ikhuphe iMibonelelo yoLawulo lweeMvavanyo ezongezelelweyo zeKliniki yeZixhobo zezoNyango (uvavanyo), ukuvumela iimveliso eziluncedo ekuqaphelisweni kweklinikhi yokuqala kodwa azikavunyelwa ukuthengisa. , isetyenziselwa izigulane ezigula kakhulu ezingenalo unyango olusebenzayo, ngaphandle kokuba imvume enolwazi ifunyenwe kunye nokuhlaziywa kokuziphatha.Ukongezelela, idatha yokhuseleko lwezilingo zeklinikhi ezandisiweyo zezixhobo zonyango zivumelekile ukuba zisetyenziswe kwisicelo sokubhalisa.
04 Imveliso yesixhobo sonyango sokuqala saseTshayina esisebenzisa idatha yasekhaya yokwenyani evunyiweyo ukuthengiswa
Ngomhla we-26 ka-Matshi, uLawulo lweeMveliso zoNyango lweSizwe luvumile ukubhaliswa kwe-"Glaucoma Drainage Tube" ye-Allergan yase-United States.Le mveliso isebenzisa ubungqina bokwenene bekliniki obuqokelelwe kwindawo yaseHainan Boao Lecheng Pioneer yokuvavanya ukuhlukana kobuhlanga, ibe yimveliso yokuqala yasekhaya evunyiweyo ngeli jelo.
05 2020 Inyathelo lokuZingela amabanjwa kwi-Intanethi yeZixhobo zoNyango likhutshwe nguLawulo lweeMveliso zonyango lweSizwe.
Ngomhla wama-29 ku-Epreli, uLawulo lweeMveliso zezoNyango lweSizwe lukhuphe i-2020 "Inyathelo lokuzingela amabanjwa kwi-Intanethi" yeZixhobo zezoNyango, ezifuna ukuba eli nyathelo liqhutywe zombini "kwi-intanethi" kunye "ngaphandle kwe-intanethi" kunye nolwazi kunye nemveliso kufuneka zidibaniswe.Eli nyathelo likwagxininise ukuba iqonga lesithathu leenkonzo zentengiselwano zesixhobo sonyango kwi-Intanethi kufuneka lithathelwe uxanduva lokulawula ezo ntengiselwano kwaye uxanduva oluphambili kufuneka lube kumashishini okuthengisa kwi-intanethi yezixhobo zonyango.Amasebe alawula iziyobisi aya kuba noxanduva lokongamela izixhobo ezithengiswayo kummandla wawo, ukubekwa esweni kweetransekshini zesixhobo sezonyango kwi-intanethi kufuneka kuqiniswe, kwaye ukwaphulwa kwemithetho nemimiselo kufuneka kupapashwe ngokuqatha.
06 I-Pilot Work I-Unique Device Ichonga (UDI) Inkqubo eqhubela phambili ngokuthe chu
NgoJulayi 24, uLawulo lweeMveliso zoNyango lweSizwe lubambe intlanganiso yokukhuthaza umsebenzi wokulinga wenkqubo yokuchongwa kwesixhobo esisodwa (UDI), ngamaxesha athile ishwankathela inkqubela kunye nokusebenza komsebenzi wokulinga inkqubo ye-UDI, kwaye iququzelele uphuhliso olunzulu lolingo. umsebenzi.NgoSeptemba 29, uLawulo lweeMveliso zoNyango lweSizwe, iKomishoni yeSizwe yezeMpilo kunye noLawulo lweSizwe loKhuseleko lwezeMpilo ngokudibeneyo bakhuphe uxwebhu lokwandisa ixesha lokulinga inkqubo ye-UDI yezixhobo zonyango ukuya kwi-31 kaDisemba 2020. Ukwandiswa kweqela lokuqala leendidi ezili-9. kunye neentlobo ezingama-69 zezixhobo zonyango zeDidi III ziya kuphunyezwa nge-1 kaJanuwari 2021.
07 Isicelo esiLingwayo soBhaliso lweSiqinisekiso soBhaliso soMbane kwiZixhobo zoNyango nguLawulo lweeMveliso zoNyango lweSizwe.
Ngomhla we-19 ku-Okthobha, uLawulo lweeMveliso zezoNyango lweSizwe lukhuphe iSibhengezo sokuSetyenziswa kweSiqinisekiso sokuBhalisa ngeKhompyutha kwiZixhobo zezoNyango, kwaye sagqiba ekubeni sikhuphe izatifikethi zobhaliso lwe-elektroniki kwizixhobo zonyango ngovavanyo oluqala nge-19 ka-Okthobha 2020. Ixesha lokulinga liya kuqala ukusuka Ngo-Oktobha 19, 2020 ukuya kutsho ngo-Agasti 31, 2021. Umda wezixhobo zonyango ezikufaneleyo ukufumana izatifikethi ezinjalo ziquka izixhobo zonyango zasekhaya zodidi lwe-III kunye nezixhobo zonyango ezithe zabhaliswa kuqala.Izatifikethi zotshintsho kunye nokuhlaziywa kobhaliso ziya kukhutshwa ngokuthe ngcembe ngokuxhomekeke kwimeko kanye.
08 IVeki yokuQala yoKhuseleko lweSixhobo sezoNyango seSizwe eBanjiweyo
Ukususela ngo-Oktobha 19 ukuya kwi-25, uLawulo lweeMveliso zoNyango lweSizwe lubambe iVeki yokuKhuthaza uKhuseleko lweSixhobo seSizwe kwiSizwe ngokubanzi.Isekelwe "ekukhuthazeni umxholo oyintloko wokuguqulwa kunye nokutsha kunye nokuphucula abaqhubi abatsha bophuhliso lwamashishini", umcimbi uhambelana nomgaqo ojoliswe kwiimfuno kunye nomgaqo ojoliswe kwiingxaki, kwaye wenza iinzame zokuvakalisa uluntu kwiinkalo ezininzi.Ngexesha lomsitho, amasebe olawulo lweziyobisi kwiindidi ezahlukeneyo asebenze ngokuhambelana kwaye aphucula ulwazi loluntu malunga nezixhobo zonyango ngokubamba imisebenzi eyahlukeneyo.
I-09 yezikhokelo zobuGcisa zokuSebenzisa iDatha ye-Real-World yoVavanyo lweKlinikhi yeZixhobo zezoNyango (zoLingo) zipapashwe.
Ngomhla we-26 kaNovemba, uLawulo lweeMveliso zezoNyango lweSizwe lukhuphe iziKhokelo zezoBugcisa zokuSebenzisa iDatha ye-Real-World ye-Clinical Evaluations ye-Medical Devices (uvavanyo) oluchaza iingcamango eziphambili ezifana nedatha yehlabathi langempela, uphando lwehlabathi langempela, kunye nobungqina behlabathi langempela.Isikhokelo sicetywayo kwiimeko eziqhelekileyo ze-11 apho ubungqina behlabathi bokwenene busetyenziselwa uvavanyo lwezonyango lwezixhobo zonyango kunye nokucacisa indlela yolwazi lwehlabathi lokwenene olusetyenziselwa ukuvavanya kwezonyango izixhobo zonyango, ngaloo ndlela kwandiswa imithombo yedatha yeklinikhi.
I-10 Ulawulo lweSizwe lokuTya kunye neDrugs olulungiselelwe ukomeleza uHlolo loMgangatho wee-Coronary Stents eziKhethiweyo kwi-Centralised Procurement
NgoNovemba, urhulumente waququzelela ukuthengwa kwe-coronary stents.Ngomhla we-11 kaNovemba, uLawulo lweeMveliso zezoNyango lweSizwe lukhuphe isaziso sokuqinisa ukulawulwa komgangatho wee-coronary stents ezikhethiweyo ekuthengeni okuphakathi kuzwelonke;Ngomhla wama-25 kaNovemba, uLawulo lweeMveliso zezoNyango lweSizwe lwaququzelela kwaye lwabiza inkomfa yevidiyo malunga nomgangatho kunye nokulawulwa kokhuseleko lwee-coronary stents ezikhethiweyo ekuthengeni okuphakathi kuzwelonke ukunyusa umgangatho kunye nokukhusela ukhuseleko lweemveliso ezikhethiweyo;Ngomhla we-10 kaDisemba, uXu Jinghe, usekela-mlawuli weSizwe soLawulo lweeMveliso zezoNyango, wakhokela iqela lokulawula kunye nophando ukuba liphande ukulawulwa komgangatho wemveliso yabenzi ababini abakhethiweyo be-coronary stent eBeijing.
Umthombo:Umbutho waseTshayina woshishino lwezixhobo zonyango
Ixesha lokuposa: May-24-2021