Ngokugadwa kwedivayisi yezokwelapha, u-2020 bekuwunyaka ogcwele izinselele namathemba. Onyakeni odlule, inqwaba yezinqubomgomo ezibalulekile zikhishwe ngokulandelana kwazo, kwenziwe impumelelo ebalulekile ekugunyazweni kwezimo eziphuthumayo, futhi sekukhona nokuqanjwa okusha... Ake sibheke emuva ndawonye ohambweni lwethu olumangalisayo lokuqondisa idivayisi yezokwelapha ngo-2020.
01 Ijubane lokubuyekezwa okuphuthumayo 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 ezimweni 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, ama-reagents okuthola i-coronavirus antibody aqala ukugunyazwa, futhi lawa ma-ejenti angahlangabezana nezidingo zemizamo yethu yokulwa nalolu bhubhane. Ngaphezu kwalokho, ezinye izinto zokusebenza zezokwelapha ezisetshenziselwa ukugunyazwa okuphuthumayo ngenjongo yokuvimbela nokulawula ubhubhane, njengama-gene sequences, ama-ventilators, kanye nezihlaziyi ze-nucleic acid ezikhulisa izinga lokushisa njalo, nazo sezigunyaziwe.
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 kwedivayisi yezokwelapha yesigaba sesi-III se-fractional flow reserve software yekhompyutha; ngoFebhuwari, i-AI "isofthiwe yokuhlaziya i-ECG" ye-Lepu Medical yabhaliswa futhi yavunyelwa; ngo-June, isofthiwe yokuxilongwa kwe-MR imaging-assisted of 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, i-National Medical Products Administration kanye neKhomishana Yezempilo Kazwelonke ngokuhlanganyela bakhipha Izinhlinzeko Zokulawulwa Kwezilingo Ezinwetshiwe Zemitholampilo Yamadivayisi Ezokwelapha (zokuhlolwa), okuvumela imikhiqizo enenzuzo ekuhlolweni komtholampilo kokuqala kodwa okungakagunyazelwa ukumakethwa. , ukusetshenziselwa iziguli ezigula kakhulu ezingenakho ukwelashwa okuphumelelayo, inqobo nje uma kutholakala imvume enolwazi futhi kwenziwa ukubuyekezwa kokuziphatha. Ngaphezu kwalokho, idatha yokuphepha yokuhlolwa okunwetshiwe komtholampilo kwemishini yezokwelapha ivunyelwe ukuthi isetshenziselwe isicelo sokubhaliswa.
04 Umkhiqizo wokuqala waseChina 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 wokuqala wasekhaya ogunyazwe ngalesi siteshi.
05 2020 Umkhankaso Wokuzingela Iziboshwa Ku-inthanethi Wamadivayisi Ezokwelapha Ikhishwe I-National Medical Products Administration
Ngomhla zingama-29 kuMbasa, iNational Medical Products Administration yakhipha u-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 okuthengisa ku-inthanethi emishini yezokwelapha. Iminyango elawula izidakamizwa izoba nesibopho sokugada amadivayisi athengiswa ngaphakathi kwendawo yawo, ukugadwa kokwenziwayo kwedivayisi yezokwelapha ku-inthanethi kufanele kuqiniswe, futhi ukuphulwa kwemithetho nezimiso kufanele kushicilelwe kanzima.
06 Isistimu Yokuhlonza Idivayisi Eyingqayizivele Yokuhlola Umsebenzi (i-UDI) Iyathuthuka Ngokuqhubekayo
Ngomhla zingama-24 kuNtulikazi, i-National Medical Products Administration yabamba umhlangano wokugqugquzela 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 Kokunakekelwa Kwezempilo Kukazwelonke ngokuhlanganyela bakhiphe idokhumenti yokwelula isikhathi sokuhlola sohlelo lwe-UDI lwemishini yezokwelapha sifike 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 Kwe-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 ngumhla zingama-31 ku-Agasti 2021. Ububanzi bemishini yezokwelapha efanelekela 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 Lokukhuthazwa Kokuphepha Kwedivayisi Yezokwelapha ezweni 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 ehlukahlukene isebenze ngokuhambisana futhi yathuthukisa ukuqwashisa komphakathi mayelana nemishini yezokwelapha ngokubamba imisebenzi ehlukahlukene.
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 Kwamadivayisi Ezokwelapha (Okuhlola) echaza imiqondo ebalulekile njengedatha yomhlaba wangempela, ucwaningo lomhlaba wangempela, nobufakazi bomhlaba wangempela. Umhlahlandlela uphakamise izimo ezivamile eziyi-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 ku-November, i-National Medical Products Administration yahlela futhi yabiza ingqungquthela yevidiyo ngekhwalithi nokugadwa kokuphepha kwama-coronary stents akhethiwe ekuthengeni okuphakathi 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 ukuphathwa kwekhwalithi yokukhiqiza kwabakhiqizi ababili abakhethiwe be-coronary stent e-Beijing.
Umthombo:Inhlangano yaseChina yemboni yemishini yezokwelapha
Isikhathi sokuthumela: May-24-2021