Binyuze mu kuzamuka kwa 2023, ukwezi kwa 2024 kwatangiye kumugaragaro.Amategeko mashya yo kubaho arashyirwaho buhoro buhoro, inganda zubuvuzi "igihe cyimpinduka" zarageze.
Muri 2024, izi mpinduka zizaba mubikorwa byubuvuzi:
01
Kuva ku ya 1 kamena, ubwoko bwibikoresho 103 "izina ryukuri"
Muri Gashyantare umwaka ushize, Ikigo cya Leta gishinzwe ibiyobyabwenge (SDA), Komisiyo y’ubuzima y’igihugu (NHC), n’ikigo cy’igihugu gishinzwe ubwishingizi bw’ubuzima (NHIA) cyasohoye “Itangazo ku cyiciro cya gatatu cyo gushyira mu bikorwa uburyo bwihariye bwo kumenyekanisha ibikoresho by’ubuvuzi”.
Ukurikije urwego rwibyago nibisabwa bikenewe, bimwe mubicuruzwa bikoreshwa rimwe gusa bikenerwa nubuvuzi bukomeye, kugura ibicuruzwa byaguzwe, ibicuruzwa bijyanye nubwiza bwubuvuzi nibindi bikoresho byubuvuzi byo mu cyiciro cya II byagaragaye nkicyiciro cya gatatu cyibikoresho byubuvuzi bifite label idasanzwe.
Ubwoko 103 bwibikoresho byubuvuzi bishyirwa mubikorwa bidasanzwe byo gushyiramo ikimenyetso, harimo ibikoresho byo kubaga ultrasound, ibikoresho byo kubaga laser hamwe nibindi bikoresho, ibikoresho byo kubaga inshuro nyinshi / radiofrequency ibikoresho byo kubaga hamwe nibindi bikoresho, ibikoresho bifatika byo kubaga endoskopi, ibikoresho byo kubaga imitsi n’umutima - umutima ibikoresho byifashishwa, ibikoresho byo kubaga amagufwa, imashini isuzuma X-ray, ibikoresho byo gufotora, ibikoresho byo gusesengura sisitemu, pompe ya syringe, ibikoresho bya laboratoire nibindi.
Dukurikije Itangazo, ku bikoresho by’ubuvuzi bikubiye mu cyiciro cya gatatu cy’urutonde rw’ishyirwa mu bikorwa, uwiyandikishije azakora imirimo ikurikira mu buryo bukurikije gahunda yagenwe:
Ibikoresho byubuvuzi byakozwe kuva 1 kamena 2024 bigomba kugira ikimenyetso cyihariye cyibikoresho byubuvuzi;ibicuruzwa mbere byakozwe mugice cya gatatu cyo gushyira mubikorwa ibimenyetso byihariye ntibishobora kugira ibimenyetso byihariye.Itariki yatangiweho igomba gushingira ku kirango cyibikoresho byubuvuzi.
Niba usaba kwiyandikisha kuva 1 kamena 2024, usaba kwiyandikisha agomba kwerekana ibicuruzwa byerekana agace gato ko kugurisha ibicuruzwa muri sisitemu yo kwiyandikisha;niba kwiyandikisha byemewe cyangwa byemejwe mbere yitariki ya 1 kamena 2024, uwiyandikishije agomba kwerekana ibicuruzwa byerekana agace gato ko kugurisha ibicuruzwa muri sisitemu yo gucunga iyandikwa mugihe ibicuruzwa byavuguruwe cyangwa byahinduwe kugirango byandikwe.
Kumenyekanisha ibicuruzwa ntabwo ari ikibazo cyo gusubiramo kwiyandikisha, kandi impinduka zumuntu kugiti cye ntiziri murwego rwo guhindura iyandikwa.
Kubikoresho byubuvuzi byakozwe kuva ku ya 1 kamena 2024, mbere yuko bishyirwa ku isoko no kugurishwa, uwiyandikishije agomba kohereza ibicuruzwa biranga ibicuruzwa bito bito, urwego rwo hejuru rwo gupakira hamwe namakuru ajyanye nububiko bwihariye bwo kumenyekanisha ibikoresho by’ubuvuzi muri ukurikije ibisabwa mubipimo ngenderwaho cyangwa ibisobanuro bijyanye, kugirango umenye neza ko amakuru ari ukuri, yuzuye, yuzuye kandi akurikiranwa.
Kubikoresho byubuvuzi byagumanye amakuru mubyiciro na kode yububiko bwibikoresho byubuvuzi byikigo cya leta cyubwishingizi bwubuvuzi bwubwishingizi bwubuvuzi, birakenewe ko huzuzwa kandi tunonosora ibyiciro hamwe na kode yimiti ikoreshwa mubuvuzi bwubwishingizi bwubuvuzi mububiko bwihariye bwihariye, kandi icyarimwe, kunoza amakuru ajyanye no kumenyekanisha bidasanzwe ibikoresho byubuvuzi mukubungabunga ibyiciro na code yububiko bwibikoresho byubuvuzi byubwishingizi bwubuvuzi kandi wemeze guhuza amakuru hamwe nububiko bwihariye bwo kumenyekanisha ibikoresho byubuvuzi.
02
Gicurasi-Kamena, icyiciro cya kane cyibikoreshwa mubisubizo byamasoko ya leta byageze kumasoko
Ku ya 30 Ugushyingo umwaka ushize, icyiciro cya kane cy’ibicuruzwa bikenerwa mu kugura amasoko ya Leta byatangaje ibisubizo byatsinzwe.Vuba aha, Beijing, Shanxi, Mongoliya Imbere n’ahandi hasohoye Itangazo ryerekeye Kugena Amasezerano yo Kugura Ibicuruzwa Byatoranijwe mu Guhuriza hamwe Guhuza Ibicuruzwa by’Ubuvuzi ku Mashyirahamwe y’igihugu, bisaba ibigo by’ubuvuzi byaho kumenya amasezerano yo kugura ibicuruzwa nka kimwe nubunini bwo kugura.
Ukurikije ibisabwa, NHPA, hamwe n’amashami bireba, bizayobora uturere n’inganda zatoranijwe gukora akazi keza mu kugwa no gushyira mu bikorwa ibisubizo byatoranijwe, kugira ngo abarwayi bo mu gihugu hose bashobore gukoresha ibicuruzwa byatoranijwe muri Gicurasi-Kamena 2024 nyuma yo kugabanuka kw'ibiciro.
Kubarwa hashingiwe ku giciro cyabanje gukusanywa, ingano y’isoko ry’ibicuruzwa byakusanyirijwe hamwe igera kuri miliyari 15.5, harimo miliyari 6.5 y’amadorari ku bwoko 11 bw’ibikoreshwa na IOL na miliyari 9 z'amadorari ku moko 19 y’imiti ikoreshwa na siporo.Hamwe nogushyira mubikorwa igiciro cyegeranijwe, bizarushaho gushimangira kwagura igipimo cyisoko rya IOL nubuvuzi bwa siporo.
03
Gicurasi-Kamena, 32 + 29 intara zikoreshwa mugukusanya ibisubizo byo gushyira mubikorwa
Ku ya 15 Mutarama, Biro y’Ubwishingizi bw’Ubuvuzi ya Zhejiang yasohoye Itangazo ku itangazo ry’ibyavuye mu gutoranya ibyavuye mu ihuriro ry’ubumwe bw’intara hagati yo kugura Coronary Intravascular Ultrasound Diagnostic Catheters na Pompe Infusion.Guhuriza hamwe kugura ibintu byubwoko bubiri bwibikoreshwa ni imyaka 3, ubarwa uhereye kumunsi nyirizina wo gushyira mubikorwa ibisubizo byatoranijwe mukarere kunze ubumwe.Umwaka wa mbere wemejwe kugura uzashyirwa mubikorwa guhera muri Gicurasi-Kamena 2024, kandi itariki ntarengwa yo kuyishyira mu bikorwa izagenwa n’akarere k’ubumwe.
Ubwoko bubiri bwo gukusanya no gutanga amasoko iyobowe na Zhejiang iki gihe gikubiyemo intara 32 na 29.
Nk’uko urubuga rwemewe rw’ikigo cy’ubwishingizi bw’ubuvuzi cya Zhejiang rubitangaza, hari ibigo 67 byitabira cyane kuri uru rubuga rw’amasoko y’ubufatanye, igabanuka ry’ikigereranyo cya coronary intravascular ultrasound kwisuzumisha catheter ugereranije n’igiciro cy’amateka kigera kuri 53%, akarere k’ubumwe buri mwaka kuzigama hafi Miliyari 1,3;ikusanyirizo rya pompe ugereranije nigiciro cyamateka cyo kugabanuka kugereranyo cya 76%, agace kunze ubumwe kuzigama buri mwaka hafi miliyari 6.66.
04
Ubuvuzi bwo kurwanya ruswa burakomeje n’ibihano biremereye kubera ruswa yo kwa muganga
Ku ya 21 Nyakanga umwaka ushize, nk'uko urubuga rwemewe rwa Komisiyo y’igihugu y’ubuzima rubitangaza, kohereza ibibazo by’umwaka umwe mu rwego rwa farumasi y’imiti y’imiti yibanze ku mirimo yo gukosora.Ku ya 28 Nyakanga, inzego zishinzwe ubugenzuzi n’ubugenzuzi zifatanya n’ibibazo bya ruswa mu rwego rwa farumasi y’igihugu byibanze ku gukangurira imirimo yo gukosora no kohereza amashusho kuri videwo, hashyirwaho iterambere ryimbitse ry’inganda z’imiti mu nzego zose, urwego rwose, gukwirakwiza byose ku miyoborere itunganijwe.
Kugeza ubu hari amezi atanu kugira ngo imirimo yo gukosora ihuriweho irangiye.2023 Mu gice cya kabiri cy'umwaka, umuyaga w’imiti wo kurwanya ruswa wibasiye igihugu cyose ku muvuduko mwinshi, bituma ingaruka zikomeye ku nganda.Kuva umwaka watangira, inama ya leta y’amashami menshi yavuze ibya farumasi yo kurwanya ruswa, ubudahangarwa bwo kurwanya ruswa buzakomeza kwiyongera mu mwaka mushya.
Ku ya 29 Ukuboza umwaka ushize, inama ya karindwi ya Komisiyo ihoraho ya Kongere y’igihugu ya cumi na kane yemeje “Ivugurura ry’amategeko ahana ya Repubulika y’Ubushinwa (XII)”, azatangira gukurikizwa guhera ku ya 1 Werurwe 2024.
Iri vugurura ryongera ku buryo bugaragara uburyozwacyaha mu bihe bimwe na bimwe bya ruswa.Ingingo ya 390 y'Itegeko mpanabyaha yahinduwe kugira ngo isome: “Umuntu wese ukora icyaha cyo gutanga ruswa, azahanishwa igifungo kuva ku gihe kitarenze imyaka itatu cyangwa gufungwa by'agateganyo, kandi acibwa amande;niba ibintu bikomeye kandi ruswa igakoreshwa kugirango haboneke inyungu zidakwiye, cyangwa niba inyungu zigihugu zifite igihombo gikomeye, azahanishwa igifungo cyigihe kitarenze imyaka itatu ariko kitarenze imyaka icumi, kandi agomba gucibwa amande;niba ibintu bikomeye cyane cyangwa niba inyungu zigihugu zifite igihombo gikomeye, azahanishwa igifungo cyigihe kitarenze imyaka icumi cyangwa igifungo cya burundu.igifungo kirenze imyaka icumi igifungo cyagenwe cyangwa igifungo cya burundu, n'ihazabu cyangwa kwamburwa ibintu. ”
Iri vugurura rivuga ko abatanga ruswa mu bijyanye n’ibidukikije, ibibazo by’imari n’imari, umusaruro w’umutekano, ibiribwa n’ibiyobyabwenge, gukumira ibiza no gutabara, ubwiteganyirize bw’abakozi, uburezi n’ubuvuzi, n’ibindi, kandi bakora ibitemewe n’ubugizi bwa nabi. ibikorwa bizahabwa ibihano biremereye.
05
Igenzura ryigihugu ryibitaro binini ryatangijwe
Mu mpera z'umwaka ushize, Komisiyo y’ubuzima y’igihugu yasohoye gahunda y’imirimo nini yo kugenzura ibitaro (Umwaka 2023-2026).Ihame, aho iri genzura rigenewe ibitaro bya leta (harimo ibitaro by’ubuvuzi by’Ubushinwa) byo mu rwego rwa 2 (bijyanye n’ubuyobozi bwa 2) no hejuru.Ibitaro bikoreshwa na societe bishyirwa mubikorwa hifashishijwe amahame yubuyobozi.
Komisiyo y’igihugu ishinzwe ubuzima n’imibereho myiza ishinzwe kugenzura ibitaro biri muri Komisiyo (ubuyobozi) no kugenzura no kuyobora igenzura ry’ibitaro muri buri ntara.Intara, uturere twigenga, amakomine ayobowe na guverinoma nkuru hamwe na komisiyo ishinzwe ubuzima n’umushinga w’ubwubatsi bw’i Sinayi hakurikijwe ihame ry’imicungire y’ubutaka, umuryango uhuriweho hamwe n’inshingano z’ubuyobozi, gukora imirimo yo kugenzura ibitaro mu buryo buteganijwe kandi intambwe ku yindi. .
Muri Mutarama uyu mwaka, ku rwego rwa kabiri (hifashishijwe urwego rwa kabiri rw’ubuyobozi) no hejuru y’ibitaro by’ubuvuzi rusange by’Abashinwa (harimo n’ubuvuzi bw’Abashinwa n’iburengerazuba byahujwe n’ibitaro by’ubuvuzi bw’amoko mato), Sichuan, Hebei n’izindi ntara bifite yasohoye kandi ibaruwa imwe imwe, kugira ngo itangire kugenzura ibitaro binini.
Igenzura ryibanze:
1. Niba gutezimbere no gushyira mubikorwa ibikorwa byo gukosora bikomatanyirijwe hamwe, "umurongo ngenderwaho icyenda" na gahunda y'ibikorwa yo gukora imyitozo isukuye yingamba zihariye zo kunoza imikorere ifatika, igamije, yoroshye gukoresha amategeko n'amabwiriza, no gushyiraho uburyo bw'igihe kirekire; .
2. Niba ibikorwa byo gukosora byibanze byageze kuri "bitandatu mu mwanya" wo gutangiza ibitekerezo, kwisuzuma no kwikosora, guhererekanya ibimenyetso, kugenzura ibibazo, gukemura ibibazo no gushyiraho uburyo.Niba gushimangira ubugenzuzi bwa "rubanda nyamwinshi" n'imyanya y'ingenzi.Niba gukurikiza amahame y "guhana gukumira, gufata neza gukiza, kwerekana kugenzura urukundo, urukundo, ubworoherane no gukomera, no gukoresha neza" uburyo bune "kugirango ukore umurimo.
3. Niba gushimangira ubugenzuzi bwo kwakira komisiyo z’ubucuruzi, kugira uruhare mu buriganya bw’ubwishingizi bw’uburiganya, kwisuzumisha birenze urugero no kuvurwa, kwakira impano mu buryo butemewe, kumenyekanisha ubuzima bwite bw’abarwayi, kubohereza inyungu, kubangamira ubutabera bw’ubuvuzi, kwakira “udupaki dutukura” kuva kuruhande rwabarwayi, no kwemera gusubira inyuma mubigo, nibindi, binyuranyije n "amabwiriza icyenda" n "" imyitozo isukuye ".Kugenzura imyitwarire isukuye.
4. Haba gushiraho no kunoza uburyo bwo gukurikirana no kuburira hakiri kare hamwe nuburyo bwo kugenzura bukubiyemo imyanya yingenzi, abakozi bakomeye, imyitwarire yingenzi yubuvuzi, imiti yingenzi n’ibikoreshwa, ibikoresho binini byubuvuzi, kubaka ibikorwa remezo, imishinga minini yo gusana nizindi ngingo zingenzi. , no gukemura neza ibibazo no gukora ubudahwema.
5. Niba gushyira mubikorwa ubunyangamugayo bwubushakashatsi bwubuvuzi hamwe n amategeko ajyanye nimyitwarire, no gushimangira kugenzura ubunyangamugayo bwubushakashatsi.
06
Guhera ku ya 1 Gashyantare, shishikarizwa guteza imbere ibyo bikoresho byubuvuzi
Ku ya 29 Ukuboza umwaka ushize, Komisiyo y’igihugu ishinzwe iterambere n’ivugurura (NDRC) yasohoye Cataloge ngenderwaho yo kugenzura imiterere y’inganda (integuro 2024).Ubusobanuro bushya bw'urwo rutonde buzatangira gukurikizwa ku ya 1 Gashyantare 2024, kandi Catalogi y'Ubuyobozi ishinzwe kugenzura imiterere y'inganda (integuro ya 2019) izavaho icyarimwe.
Mu rwego rwubuvuzi, iterambere rishya ryibikoresho byo mu rwego rwo hejuru birashishikarizwa.
By'umwihariko, ikubiyemo: gene nshya, poroteyine n'ibikoresho byo gusuzuma selile, ibikoresho bishya byo gupima ubuvuzi na reagent, ibikoresho byerekana amashusho y’ubuvuzi bikora neza, ibikoresho byo mu rwego rwo hejuru bya radiotherapi, ibikoresho bifasha ubuzima indwara zikomeye kandi zikomeye, ibikoresho by’ubuvuzi bifashwa n’ubwenge, ibikoresho bigendanwa kandi byifashishwa mu gusuzuma no kuvura, ibikoresho byo mu rwego rwo hejuru byo gusubiza mu buzima busanzwe, ibicuruzwa byo mu rwego rwo hejuru byatewe kandi byifashishwa, imashini zo kubaga, n'ibindi bikoresho byo mu rwego rwo hejuru byo kubaga n'ibikoreshwa, ibikoresho bikomoka ku binyabuzima, guteza imbere ikoranabuhanga ryongera inganda no kubishyira mu bikorwa.iterambere ry'ikoranabuhanga no kuyishyira mu bikorwa.
Byongeye kandi, ubuvuzi bwubwenge, sisitemu yubuvuzi sisitemu yo kwisuzumisha, robot yubuvuzi, ibikoresho byambara, nibindi nabyo biri murutonde rwashishikarijwe.
07
Mu mpera za Kamena, iyubakwa ry’imiryango y’ubuvuzi y’intara yegeranye izatera imbere byimazeyo
Mu mpera z'umwaka ushize, Komisiyo y’igihugu y’ubuzima n’andi mashami 10 bafatanije gutanga ibitekerezo ku bijyanye no guteza imbere byimazeyo iyubakwa ry’imiryango y’ubuvuzi n’ubuvuzi y’intara yegeranye.
Ivuga ko: mu mpera za Kamena 2024, kubaka imiryango y’ubuvuzi y’intara yegeranye bizatezwa imbere ku buryo bwuzuye ku ntara;mu mpera za 2025, intambwe nini izagerwaho mu iyubakwa ry’ubuvuzi bw’intara, kandi tuzaharanira ko imiryango y’ubuvuzi y’intara yegeranye ifite imiterere ihamye, imicungire ihuriweho n’abakozi n’imari, imbaraga n’inshingano, imikorere inoze, igabana ry'umurimo, gukomeza serivisi, no guhanahana amakuru mu bice birenga 90% by'intara (amakomine) mu gihugu hose;kandi mu 2027, iyubakwa ry’imiryango y’ubuvuzi y’intara yegereye izatezwa imbere byimazeyo.Kugeza 2027, imiryango yubuvuzi yegereye intara izageraho ikore neza.
Uruziga rugaragaza ko ari ngombwa kunoza imiyoboro ya serivisi ishinzwe ubuvuzi bwa telemedine, kumenya inama za kure, gusuzuma no guhugura hamwe n'ibitaro byo mu rwego rwo hejuru, no guteza imbere kumenyekanisha ibizamini byo mu nzego z'ibanze, gusuzuma indwara zo mu rwego rwo hejuru n'ibisubizo.Gufata intara nkigice kimwe, serivise ya telemedine izakorera hejuru ya 80% byibitaro byubuzima byumujyi n’ibigo nderabuzima by’abaturage mu 2023, kandi ahanini bizagera ku 2025, kandi biteze imbere kugeza ku rwego rw’umudugudu.
Bitewe no kubaka imiryango y’ubuvuzi yo mu ntara mu gihugu hose, isoko ry’isoko ryo kugura ibikoresho byo mu nzego z'ibanze ryiyongera vuba, kandi amarushanwa ku isoko ryo kurohama ariyongera cyane.
Hongguan yita kubuzima bwawe.
Reba ibicuruzwa byinshi bya Hongguan →https://www.hgcmedical.com/ibicuruzwa/
Niba hari ibikenewe mubuvuzi, nyamuneka twandikire.
hongguanmedical@outlook.com
Igihe cyo kohereza: Gashyantare-28-2024