Kutariswa kwemidziyo yekurapa, 2020 rave gore rizere nematambudziko uye tariro. Mugore rapfuura, mitemo yakawanda yakakosha yakabudiswa zvakatevedzana, mabhindauko makuru akaitwa mumvumo yechimbichimbi, uye hunyanzvi hwakasiyana siyana hwavepo…
01 Kumhanya kwekuongorora nekukurumidza uye kubvumidzwa kwemidziyo yekurapa kwakakwidziridzwa mukuedza kwedu kudzivirira nekudzora denda.
Mushure mekubuda kweCovid-19, iyo Center for Medical Device Evaluation yeNational Medical Products Administration yakatanga hurongwa hwekuongororwa kwechimbichimbi muna Ndira 21. Vaongorori vakapindira pachine nguva uye vakapindura njodzi maawa makumi maviri nemana pazuva kuti vape masevhisi epamusoro ekunyoresa vanyoreri kune chigadzirwa. kusimudzira nekunyoresa. Musi wa26 Ndira, mamwe ma coronavirus nucleic acid yekuona reagents akatanga kubvumidzwa muChina; muna Kukadzi 22, coronavirus antibody yekuona reagents yakatanga kubvumidzwa, uye vamiririri ava vanogona kuzadzisa zvatinoda kuedza kurwisa denda. Uye zvakare, zvimwe zvekushandisa zvekurapa zvinoshandiswa kubvumidzwa kwekukurumidzira nechinangwa chekudzivirira uye kutonga kwedenda, senge gene sequencers, ventilators, uye nguva dzose tembiricha amplification nucleic acid analyzers, zvakabvumidzwawo.
02 Zvishandiso zvinoverengeka zvehunyanzvi zvekurapa zvakabvumidzwa kushambadzira.
Gore rino, China yakaona kubudirira kukuru mukubvumidzwa kwemidziyo yekurapa yehungwaru. Muna Ndira, Beijing Kunlun Medical Cloud Technology Co., Ltd. yakawana yekutanga intelligence kirasi III yekurapa mudziyo wekunyoresa chitupa chechikamu chechikamu chekuyerera reserved computational software; munaFebruary, iyo AI "ECG yekuongorora software" yeLepu Medical yakanyoreswa uye yakabvumidzwa; muna June, MR imaging-assisted diagnosis software ye intracranial tumors yakagamuchirwa seClass III mishonga yezvokurapa; Muna July, AI "ECG machine" yeLepu Medical yakagamuchirwa; Muna Nyamavhuvhu, chigadzirwa chitsva "Diabetic retinopathy fundus image-aid diagnosis software" yakabudiswa naShenzhen Siji Intelligent Technology Co., Ltd. uye "Diabetic retinopathy analysis software" yakagadzirwa neShanghai Yingtong Medical Technology Co., Ltd. yakatenderwa kuti inyore. Kubva muna Zvita 16, zviyero gumi zvezvigadzirwa zvehunyanzvi zvekurapa zvakabvumidzwa kunyorwa.
03 Zvirongwa pamusoro peKutungamirirwa kweMakiriniki Yakawedzerwa Miedzo yeMishonga Yezvokurapa (yeKuedzwa) Yakashambadzirwa
Musi waKurume 20, National Medical Products Administration neNational Health Commission vakabatana vakapa maProvisions on the Administration of Extended Clinical Trials of Medical Devices (yeMuedzo), vachibvumira zvigadzirwa zvinobatsira mukutariswa kwekutanga kwekiriniki asi zvisati zvabvumidzwa kushambadzira. , kushandiswa kuvarwere vanorwara zvakanyanya vasina kurapwa kunoshanda, kunze kwekuti kubvumirwa kunowanikwa uye kuongororwa kwetsika kunoitwa. Uye zvakare, iyo data yekuchengetedza yeakawedzera kiriniki miedzo yemidziyo yekurapa inotenderwa kushandiswa pakunyoresa kunyorera.
04 China Chekutanga chigadzirwa chekurapa chinoshandisa yepasi-chaiyo data yakatenderwa kushambadzira
Musi wa26 Kurume, National Medical Products Administration yakatendera kunyoreswa kwe "Glaucoma Drainage Tube" yeAllergan yekuUnited States. Ichi chigadzirwa chinoshandisa humbowo hwekiriniki hwepasirese hwakaunganidzwa muHainan Boao Lecheng Pioneer Area yekuongorora mutsauko wemadzinza, ichiva chekutanga chigadzirwa chepamba chakabvumidzwa kuburikidza neiyi chiteshi.
05 2020 Kuvhima Vasungwa Pamhepo Initiative yeMidziyo Yekurapa Yakaburitswa neNational Medical Products Administration.
Musi wa29 Kubvumbi, National Medical Products Administration yakapa 2020 "Hunting Convicts Online Initiative" yeMedical Devices, izvo zvinoda kuti chirongwa ichi chiitwe zvese "pamhepo" uye "kunze" uye ruzivo nechigadzirwa zvinofanirwa kubatanidzwa. Danho iri rakasimbisawo kuti chechitatu-bato chikuva chepamhepo dhizaini yekutengeserana masevhisi anofanirwa kuzvidavirira pakugadzirisa kutengeserana kwakadaro uye basa rekutanga rinofanira kunge riri pamabhizinesi ekutengesa epamhepo emidziyo yekurapa. Madhipatimendi anoona nezvezvinodhaka achange ane basa rekutarisisa midziyo inotengeswa mukati medunhu ravo, kutariswa kwemashandisirwo ezvishandiso zvekurapa pamhepo kunofanirwa kukwidziridzwa, uye kutyorwa kwemitemo nemirau kunofanirwa kuburitswa zvakanyanya.
06 Pilot Work Yakasarudzika Device Identification (UDI) Sisitimu Inofambira mberi Zvishoma
Musi waChikunguru 24, National Medical Products Administration yakaita musangano wekusimudzira basa rekutyaira reiyo yakasarudzika mudziyo wekuzivikanwa (UDI) system, nguva nenguva ichipfupikisa mafambiro uye kushanda kweiyo basa rekutyaira reUDI system, uye kufambisa budiriro yakadzama yemutyairi. shanda. Musi wa29 Gunyana, National Medical Products Administration, National Health Commission neNational Healthcare Security Administration vakabatana vakaburitsa gwaro rekuwedzera nguva yekuyedza yeUDI system yemidziyo yekurapa kusvika Zvita 31, 2020. Kuwedzerwa kwechikamu chekutanga chezvikamu 9. uye 69 mhando dzeClass III michina yekurapa ichashandiswa muna Ndira 1, 2021.
07 Pilot Kushandiswa kweEletroniki Kunyoreswa Chitupa cheMishonga Yezvokurapa neNational Medical Products Administration.
Musi wa19 Gumiguru, National Medical Products Administration yakapa Chiziviso pamusoro pePilot Application yeElectronics Registration Certificate yeMedical Devices, uye yakafunga kupa zvitupa zvemagetsi zvekunyoresa zvemidziyo yekurapa padanho rekutyaira kutanga kubva Gumiguru 19, 2020. Nguva yekuyedza ichatanga kubva Gumiguru 19, 2020 kusvika Nyamavhuvhu 31, 2021. Hukuru hwemidziyo yekurapa inokodzera kugashira zvitupa zvakadaro inosanganisira Kirasi III midziyo yekurapa yemumba nemidziyo yekurapa yeKirasi II uye III inotengwa kunze kwenyika iyo yakatanga kunyoreswa. Zvitupa zvekuchinja uye kuvandudzwa kwekunyoresa zvichapihwa zvishoma nezvishoma zvichienderana nemamiriro chaiwo.
08 Vhiki Yekutanga Yezvokurapa Nekuchengetedza Chishandiso Chekuchengetedza Vhiki Yakaitwa
Kubva Gumiguru 19 kusvika 25, National Medical Products Administration yakaita Yekutanga National Medical Device Safety Promotion Vhiki pamwero wenyika yose. Yakanangana ne "kusimudzira dingindira guru rekuvandudza uye kuvandudza uye kuvandudza vatyairi vatsva vekusimudzira maindasitiri", chiitiko ichi chakateedzera musimboti wakanangana nezvinodiwa uye wakatarisana nedambudziko, uye wakaita nhamburiko dzayo dzekuzivisa muzvinhu zvakawanda. Panguva yechiitiko ichi, madhipatimendi anodzora zvinodhaka mune akasiyana akashanda tandem uye akasimudzira veruzhinji ruzivo nezvemidziyo yekurapa nekubata zvakasiyana-siyana zviitiko.
09 Mirayiridzo yeTekinoroji yeKushandisa Yechokwadi-Nyika Dhata yeMakiriniki Ekuongorora eMidziyo Yekurapa (yeKuedzwa) Yakaburitswa.
Musi waNovember 26, National Medical Products Administration yakabudisa iyo Technical Guidelines yeKushandisa Real-World Data yeClinical Evaluations of Medical Devices (yeMuedzo) iyo inotsanangura pfungwa dzakakosha dzakadai sedhiyabhorosi yenyika chaiyo, tsvakurudzo yenyika chaiyo, uye uchapupu hwepanyika chaiyo. Nhungamiro yakakurudzira 11 mamiriro ezvinhu akajairika umo humbowo hwepasirese hunoshandiswa mukuongororwa kwekiriniki yemidziyo yekurapa uye kujekesa nzira yedhiyabhorosi yepasirese inoshandiswa mukuongororwa kwekiriniki yezvishandiso zvekurapa, nekudaro kuwedzera masosi e data yekiriniki.
10 Iyo National Chikafu neDrug Administration Yakarongwa Kuti Isimbise Hutarisiro Hwemhando yeCoronary Stents Yakasarudzwa muCentralized Procurement.
MunaNovember, nyika yakaronga kutengwa kwepakati kwema coronary stents. Musi waNovember 11, National Medical Products Administration yakapa chiziviso chekusimbisa kutariswa kwemhando yezvakasarudzwa coronary stents mukutenga kwenyika pakati; Musi waMbudzi 25, National Medical Products Administration yakaronga uye yakadaidza musangano wevhidhiyo pamusoro pemhando uye kuchengetedzwa kwekutarisa kweakasarudzwa coronary stents mukutenga kwepakati kwenyika kusimudzira kunaka uye kuchengetedzwa kwekutarisa kwezvinhu zvakasarudzwa; Musi waZvita 10, Xu Jinghe, mutevedzeri wemukuru weNational Medical Products Administration, akatungamira boka revatariri uye rekuferefeta kuti riongorore manejimendi emhando yekugadzirwa kwevaviri vakasarudzwa vagadziri veconary stent muBeijing.
Kunobva:China mubatanidzwa weindasitiri yemidziyo yekurapa
Nguva yekutumira: May-24-2021