Ngokugadwa kwemishini yezokwelapha, u-2020 bekuwunyaka ogcwele izinselele namathemba.Onyakeni odlule, inqwaba yezinqubomgomo ezibalulekile zikhishwe ngokulandelana kwazo, kwenziwe impumelelo ebalulekile ekugunyazweni kwezimo eziphuthumayo, futhi sekukhona izinto ezintsha eziqanjiwe... Ake sibheke emuva ndawonye ohambweni lwethu olumangalisayo lokuqondisa idivayisi yezokwelapha ngo-2020.
01 Ijubane lokubuyekezwa okuphuthumayo kanye nokugunyazwa kwemishini yezokwelapha liye lashesha emizamweni yethu yokuvimbela nokulawula ubhubhane.
Ngemva kokugqashuka kwe-Covid-19, i-Center for Medical Device Evaluation of National Medical Products Administration yethule inqubo yokubuyekeza izimo eziphuthumayo ngoJanuwari 21. Ababuyekezi bangenelela kusenesikhathi futhi basabela ezimeni eziphuthumayo amahora angu-24 ngosuku ukuze banikeze izinsizakalo ezithuthukisiwe kwabafake izicelo zokubhalisa umkhiqizo. ukuthuthukiswa kanye nokubhaliswa.NgoJanuwari 26, amanye ama-reagents okuthola i-coronavirus nucleic acid aqala ukuvunyelwa eChina;ngoFebhuwari 22, izindawo zokutholwa kwe-coronavirus antibody zaqala ukugunyazwa, futhi lawa ma-ejenti angahlangabezana nezidingo zemizamo yethu yokulwa nalolu bhubhane.Ngaphezu kwalokho, ezinye izinto zezokwelapha ezisetshenziselwa ukugunyazwa kwezimo eziphuthumayo ngenjongo yokuvimbela nokulawula ubhubhane, njengama-gene sequences, ama-ventilators, kanye nezihlaziyi ze-nucleic acid ezikhulisa izinga lokushisa eziqhubekayo, nazo zigunyaziwe.
02 Imishini eminingi yezokwelapha enobuhlakani bokwenziwa yagunyazwa ukuthi imakethwe.
Kulo nyaka, i-China ibone impumelelo enkulu ekuvunyweni kwemishini yezokwelapha ehlakaniphile yokwenziwa.NgoJanuwari, i-Beijing Kunlun Medical Cloud Technology Co., Ltd. yathola isitifiketi sokuqala sokubhaliswa kwensiza yezokwelapha yesigaba III sobuhlakani bokwenziwa nge-software yayo yokubala ye-fractional flow reserve;ngoFebhuwari, i-AI "isofthiwe yokuhlaziya i-ECG" ye-Lepu Medical yabhaliswa futhi yavunyelwa;ngo-June, isofthiwe ye-MR imaging-assisted diagnosis for intracranial tumors yavunywa njengemishini yezokwelapha ye-Class III;NgoJulayi, i-AI "ECG machine" ye-Lepu Medical yamukelwa;Ngo-August, umkhiqizo omusha othi “Diabetic retinopathy fundus image-aid diagnosis software” okhiqizwe yi-Shenzhen Siji Intelligent Technology Co., Ltd. kanye “nesoftware yokuhlaziya i-Diabetic retinopathy” ekhiqizwe yi-Shanghai Yingtong Medical Technology Co., Ltd. yagunyazwa ukuthi ifakwe ohlwini.Kusukela ngomhla ka-16 Disemba, isamba semikhiqizo eyi-10 yemishini yezokwelapha ehlakaniphile igunyaziwe ukuthi ifakwe kuhlu.
03 Izinhlinzeko Zokulawulwa Kwezilingo Zomtholampilo Ezandisiwe Zamadivayisi Ezokwelapha (zokuhlolwa) Zimenyezelwe
Ngomhla zingama-20 kuNdasa, Ukuphathwa Kwemikhiqizo Yezokwelapha Kazwelonke kanye Nekhomishana Yezempilo Kazwelonke ngokuhlanganyela bakhipha Izinhlinzeko Zokuphathwa Kwesivivinyo Esandisiwe Semitholampilo Yamadivayisi Ezokwelapha (okuhlola), okuvumela imikhiqizo enenzuzo ekuhlolweni komtholampilo kokuqala kodwa okungakagunyazwa ukuthi ikhangiswe. , ukusetshenziselwa iziguli ezigula kakhulu ezingenakho ukwelashwa okuphumelelayo, inqobo nje uma kutholwa imvume enolwazi futhi kwenziwa ukubuyekezwa kokuziphatha.Ngaphezu kwalokho, idatha yokuphepha yokuhlolwa okunwetshiwe komtholampilo kwemishini yezokwelapha ivunyelwe ukuthi isetshenziselwe isicelo sokubhaliswa.
04 Umkhiqizo wokuqala waseShayina wensiza yezokwelapha esebenzisa idatha yasekhaya yomhlaba wangempela egunyazelwe ukumakethwa
Ngomhla zingama-26 kuNdasa, i-National Medical Products Administration igunyaze ukubhaliswa kwe-“Glaucoma Drainage Tube” ye-Allergan yase-United States.Lo mkhiqizo usebenzisa ubufakazi bomtholampilo bomhlaba wangempela obuqoqwe e-Hainan Boao Lecheng Pioneer Area ukuze kuhlolwe ukuhlukana kwezinhlanga, ube umkhiqizo wasekhaya wokuqala ogunyazwe ngalesi siteshi.
05 2020 Umkhankaso Wokuzingela Iziboshwa Eziku-inthanethi Wamadivayisi Ezokwelapha Ikhishwe I-National Medical Products Administration
Ngomhla zingama-29 kuMbasa, iNational Medical Products Administration yakhipha ngo-2020 “Isinyathelo Sokuzingela Iziboshwa Ku-inthanethi” samadivayisi wezokwelapha, esidinga ukuthi isinyathelo kufanele senziwe “ku-inthanethi” kanye “nokungaxhunyiwe ku-inthanethi” futhi ulwazi nomkhiqizo kufanele kuhlanganiswe.Lesi sinyathelo siphinde sagcizelela ukuthi inkundla yezinkampani zangaphandle yamasevisi okwenziwa kwedivayisi yezokwelapha eku-inthanethi kufanele ithweswe icala ngokuphatha imisebenzi enjalo futhi umthwalo wemfanelo oyinhloko kufanele ube kumabhizinisi athengisa ku-inthanethi emishini yezokwelapha.Iminyango elawula izidakamizwa izoba nesibopho sokugada izisetshenziswa ezithengiswa ngaphakathi kwendawo yayo, ukugadwa kokwenziwayo kwemishini yezokwelapha ku-inthanethi kufanele kuqiniswe, futhi ukuphulwa kwemithetho nezimiso kufanele kushicilelwe kanzima.
06 Isistimu Yokuhlonza Idivayisi Eyingqayizivele (i-UDI) Ye-Pilot Work Iyathuthuka Ngokuqhubekayo
Ngomhla zingama-24 kuNtulikazi, i-National Medical Products Administration yabamba umhlangano wokukhuthaza umsebenzi wokuhlola wesistimu yokuhlonza idivayisi eyingqayizivele (i-UDI), ngezikhathi ezithile ifingqa inqubekelaphambili nempumelelo yomsebenzi wokuhlola wohlelo lwe-UDI, kanye nokwenza lula ukuthuthukiswa okujulile komshayeli wokuhlola. umsebenzi.Ngomhla zingama-29 kuSeptemba, i-National Medical Products Administration, Ikhomishana Yezempilo Kazwelonke kanye Nokuphathwa Kwezokuphepha Kwezempilo Kazwelonke ngokuhlanganyela bakhiphe idokhumenti yokwelula isikhathi sokuhlola sohlelo lwe-UDI lwemishini yezokwelapha sifinyelele kuDisemba 31, 2020. Ukwelulwa kweqoqo lokuqala lezigaba eziyi-9. kanye nezinhlobo ezingu-69 zemishini yezokwelapha ye-Class III izosetshenziswa ngoJanuwari 1, 2021.
07 Isicelo Sokulinga Sesitifiketi Sokubhaliswa Nge-elekthronikhi Samadivayisi Ezokwelapha yi-National Medical Products Administration
Ngomhlaka-19 Okthoba, i-National Medical Products Administration yakhipha Isimemezelo Sesicelo Sokulinga Sesitifiketi Sokubhaliswa Nge-elekthronikhi Samadivayisi Ezokwelapha, futhi yanquma ukukhipha izitifiketi zokubhalisa ngogesi zemishini yezokwelapha ngendlela yokuhlola kusukela ngomhla ka-19 Okthoba 2020. Isikhathi sokuhlola sizoqala kusukela Okthoba 19, 2020 kuze kube ngu-Agasti 31, 2021. Ububanzi bemishini yezokwelapha efanelekele ukuthola izitifiketi ezinjalo ihlanganisa imishini yezokwelapha yasekhaya Yesigaba III kanye nemishini yezokwelapha engenisiwe Yesigaba II kanye nesesi-III ezibhaliswe okokuqala.Izitifiketi zezinguquko kanye nokuvuselelwa kokubhaliswa zizokhishwa kancane kancane kuye ngesimo sangempela.
08 Iviki Lokuqala Likazwelonke Lokukhuthazwa Kokuphepha Kwedivayisi Yezokwelapha Elibanjwa
Kusukela ngo-Okthoba 19 kuya ku-25, Ukuphathwa Kwemikhiqizo Yezokwelapha Kazwelonke kubambe Iviki Lokuqala Likazwelonke Lokukhuthazwa Kokuphepha Kwedivayisi Yezokwelapha esikalini sezwe lonke.Igxile “ekukhuthazeni itimu eyinhloko yezinguquko kanye nokuqanjwa kabusha kanye nokwenza ngcono abashayeli abasha bokuthuthukiswa kwezimboni”, umcimbi ubambelele kumgomo ogxile ekufuneni futhi ogxile ezinkingeni, futhi wenza imizamo yawo yokukhangisa ezicini eziningi.Ngesikhathi somcimbi, iminyango elawula izidakamizwa kwehlukene isebenze ngokuhambisana futhi yathuthukisa ukuqwashisa komphakathi mayelana nemishini yezokwelapha ngokubamba imisebenzi eyahlukene.
09 Imihlahlandlela Yezobuchwepheshe Yokusebenzisa Idatha Yomhlaba Wangempela Yokuhlolwa Komtholampilo Wamadivayisi Ezokwelapha (okuhlolwa) Kumenyezelwe.
Ngomhla zingama-26 kuNovemba, i-National Medical Products Administration yakhipha Iziqondiso Zobuchwepheshe Zokusebenzisa Idatha Yomhlaba Wangempela Yokuhlolwa Komtholampilo Wamadivayisi Ezokwelapha (Okuhlola) echaza imiqondo ebalulekile njengedatha yomhlaba wangempela, ucwaningo lomhlaba wangempela, nobufakazi bomhlaba wangempela.Umhlahlandlela uphakamise izimo ezivamile ezingu-11 lapho kusetshenziswa ubufakazi bomhlaba wangempela ekuhlolweni komtholampilo kwemishini yezokwelapha futhi sacacisa indlela yedatha yomhlaba wangempela esetshenziswa ekuhlolweni komtholampilo kwamadivayisi wezokwelapha, ngaleyo ndlela kunwetshwe imithombo yedatha yomtholampilo.
10 Ukuphathwa Kwezokudla Nezidakamizwa Kukazwelonke Kuhlelelwe Ukuqinisa Ukugadwa Kwekhwalithi Yama-Coronary Stents Akhethiwe Ekuthengeni Okuphakathi
NgoNovemba, umbuso wahlela ukuthengwa okuphakathi kwama-coronary stents.Ngomhla ziyi-11 kuNovemba, i-National Medical Products Administration yakhipha isaziso sokuqinisa ukugadwa kwekhwalithi yama-coronary stents akhethiwe ekuthengeni okuphakathi kuzwelonke;Ngomhla zingama-25 kuNovemba, i-National Medical Products Administration yahlela futhi yabiza inkomfa ngevidiyo ngekhwalithi nokugadwa kokuphepha kwama-coronary stents akhethiwe ekuthengeni okumaphakathi kuzwelonke ukuze kukhuliswe izinga nokugadwa kokuphepha kwemikhiqizo ekhethiwe;Ngomhla ziyi-10 kuZibandlela, uXu Jinghe, isekela lomqondisi we-National Medical Products Administration, wahola ithimba eligadayo kanye nophenyo ukuze liphenye ngokuphathwa kwekhwalithi yokukhiqiza kwabakhiqizi ababili abakhethiwe be-coronary stent e-Beijing.
Umthombo:Inhlangano yaseChina yemboni yemishini yezokwelapha
Isikhathi sokuthumela: May-24-2021