Ukuze sijulise nakakhulu ukuguqulwa kokubuyekezwa kwedivayisi yezokwelapha kanye nesistimu yokugunyazwa, ngokusekelwe ekuthuthukisweni kwemboni yemishini yezokwelapha kanye nokugadwa kwangempela nokuphathwa kwemishini yezokwelapha, ngokuvumelana “neMithethonqubo Yokuqondisa Nokuphathwa Kwamadivayisi Ezokwelapha” , "Ikhathalogu Yokuhlukaniswa Kwamadivayisi Ezokwelapha Izinqubo Zokusebenza Ezinamandla", I-State Drug Administration inqume ukulungisa okunye okuqukethwe "Kwekhathalogi Yokuhlukanisa Yamadivayisi Ezokwelapha".Izindaba ezifanele zimenyezelwa kanje:
Ukulungiswa kwamakilasi angu-58 emishini yezokwelapha ehlobene nokuqukethwe “Kwekhathalogi Yokuhlukaniswa Kwedivayisi Yezokwelapha”, izinguquko ezithile ziboniswa kusijobelelo.
Izidingo Zokusebenzisa
(I) Mayelana nokulungiswa okukuSijobelelo okuhlobene ne-01-01-03 “izinsiza zemishini yokuhlinza ye-ultrasonic” “ekhanda le-ultrasonic cutting ne-hemostasis, ikhanda lokuhlinza elithambile elithambile, i-ultrasonic suction surgical head” kanye no-01-01-06 “ibele Isistimu ye-rotary excision biopsy kanye nezinsiza” eziphathwa njengemishini yezokwelapha ye-Class III, kusukela ngedethi yokushicilelwa kwalesi simemezelo, umnyango olawula izidakamizwa, ngokuhambisana “Nokubhaliswa Kwedivayisi Yezokwelapha Nezesekeli”, “inalithi yokubhoboza ibele kanye izesekeli”.Isistimu ye-biopsy ye-breast rotary kanye nezinsiza” kokuthi “izinaliti zokubhobozwa kwe-Breast rotary nezisetshenziswa”, kusukela ngedethi yalesi simemezelo, iminyango yokugada izidakamizwa kanye nokuphatha ngokuvumelana “Nezinyathelo Zokubhaliswa Kwedivayisi Yezokwelapha kanye Nezinyathelo Zokulawula Ukufaka” “Esimemezelweni So Izimfuneko Zokubhaliswa Kwamadivayisi Ezokwelapha kanye Nefomethi Yombhalo Wokuvunyelwa” nokunye.Isimemezelo Sokushicilelwa Kwezimfuneko Zokubhaliswa Kwedivayisi Yezokwelapha kanye Nefomethi Yedokhumenti Yokuvunyelwa”, njll., umnyango olawula izidakamizwa uzosamukela isicelo sokubhaliswa kwemishini yezokwelapha ngokuya ngesigaba esilungisiwe.
Ngoba isimemezelo samukelwe ngaphambi kokuphothulwa kokugunyazwa kokubhaliswa (okuhlanganisa ukubhaliswa kokuqala nokuqhutshwa kokubhaliswa) kwemishini yezokwelapha, iminyango yokuqondisa izidakamizwa kanye nokuphatha iyaqhubeka nokubuyekeza nokugunyazwa ngokuvumelana nokwamukelwa kwasekuqaleni kwesigaba, ukubhaliswa kuyavunywa, ukukhishwa kwesitifiketi sokubhaliswa kwedivayisi yezokwelapha, okukhawulelwe ekubeni semthethweni kwesitifiketi sokubhaliswa kwemishini yezokwelapha yomnqamulajuqu wangomhla zingama-31 kuZibandlela 2025, nakukholomu yamazwana esitifiketi sokubhaliswa ngemva kokulungiswa kwesigaba sokuphathwa komkhiqizo.Ngoba uthole isitifiketi sokubhaliswa kwemishini yezokwelapha ye-Class II, ngaphambi komhla zingama-31 kuZibandlela wezi-2025 isitifiketi sokubhaliswa komkhiqizo siqhubeka sisebenza, obhalisiwe kufanele abandakanywe ngokuhambisana nezidingo ezifanele zesigaba sokuphatha esihambisanayo ukuze enze ukuguqulwa kokubhaliswa ngenkuthalo. isitifiketi, ngaphambi kukaDisemba 31, 2025 ukuqedela ukuguqulwa.Yenza umsebenzi wokuguqula ngesikhathi sesitifiketi sokubhaliswa kwedivayisi yezokwelapha yoqobo siphelelwa yisikhathi, ekuphepheni komkhiqizo futhi kusebenza ngempumelelo futhi esohlwini lwesisekelo sokungabi bikho kwezehlakalo ezimbi kakhulu noma izingozi zekhwalithi, obhalisiwe angahambisana nezibaluli zokuphatha zangempela kanye nezigaba kokwangempela. umnyango wokugunyaza wokufaka isicelo sesandiso, esizonwetshwa, ukufaneleka kwesitifiketi sokuqala sokubhaliswa kwedivayisi yezokwelapha ngeke kube ngaphezu kuka-December 31, 2025.
Kusukela ngomhlaka-1 Januwari 2026, leyo mikhiqizo ngeke ikhiqizwe, ingeniswe futhi ithengiswe ngaphandle kokuthola isitifiketi sokubhaliswa kwemishini yezokwelapha ye-Class III ngokuvumelana nomthetho.Abakhiqizi abafanelekile kufanele basebenzise ngempumelelo isibopho esiyinhloko sekhwalithi nokuphepha komkhiqizo ukuze baqinisekise ukuphepha nokusebenza ngempumelelo kwemikhiqizo esohlwini.
(B) ukuze kulungiswe okuqukethwe kweminye imikhiqizo, kusukela ngosuku lokushicilelwa kwalesi simemezelo, iminyango yokuqondisa izidakamizwa kanye nokuphatha ngokusekelwe “Ekubhaliseni Nokufakwa Kwamadivayisi Ezokwelapha” “esimemezelweni sezimfuneko zokubhaliswa kwemishini yezokwelapha. ukumemezela ulwazi nokugunyazwa kwefomethi yedokhumenti” “ekufayilweni kwemishini yezokwelapha ye-Class I ngesimemezelo sezindaba ezifanele” nokunye, ngokuhambisana nesigaba esilungisiwe ukwamukela isicelo sokubhaliswa kwemishini yezokwelapha noma okwerekhodi.
Ngoba owamukelwe akakaqedi imvume yokubhalisa (okuhlanganisa ukubhaliswa kokuqala nokuvuselelwa kokubhaliswa) kwemishini yezokwelapha, iminyango yokuqondisa izidakamizwa kanye nokuphatha iyaqhubeka nokubuyekeza nokugunyazwa ngokuhambisana nesigaba sokuqala sokwamukelwa, ukubhaliswa kuyavunywa, ukukhishwa kwezidakamizwa. isitifiketi sokubhaliswa kwedivayisi yezokwelapha, nakukholomu yesitifiketi sokubhaliswa ngemva kokulungiswa kwesigaba sokuphathwa komkhiqizo.
Emishinini yezokwelapha ebhalisiwe, isigaba sayo sokuphatha kusukela kusigaba sesithathu esilungiselwe isigaba sesibili, isitifiketi sokubhaliswa kwedivayisi yezokwelapha esikhathini sokuqinisekisa siyaqhubeka nokusebenza.Uma udinga ukuqhubeka, obhalisiwe kufanele abe sesitifiketini sokubhaliswa kwedivayisi yezokwelapha esiphelelwa yisikhathi izinyanga ezingu-6 ngaphambi kosuku lokuphelelwa yisikhathi, ngokuhambisana nesigaba ngemva koshintsho emnyangweni ofanele wokuqondisa nowokuphatha ukuze afake isicelo sokuvuselela ukubhaliswa, kunikezwe ukuvuselelwa. yokubhaliswa, ngokuhambisana nesigaba esilungisiwe sokuphathwa komkhiqizo esikhishwe yisitifiketi sokubhaliswa kwedivayisi yezokwelapha.
Emishinini yezokwelapha ebhalisiwe, isigaba sayo sokuphatha kusukela kusigaba sesibili esilungiswe kuya esigabeni sokuqala, isitifiketi sokubhaliswa kwedivayisi yezokwelapha ngesikhathi sokufaneleka siyaqhubeka sisebenza.Ngaphambi kokuphelelwa yisikhathi kwesitifiketi sokubhalisa, obhalisiwe angafaka isicelo serekhodi lomkhiqizo emnyangweni ohambisana nawo.
Isitifiketi sokubhaliswa kwedivayisi yezokwelapha ngaphakathi kokufaneleka kwezinguquko zokubhalisa, obhalisiwe uzofaka isicelo emnyangweni wokubhalisa wangempela ukuze ashintshe ukubhaliswa.Uma isitifiketi sokubhaliswa kwangempela sikhishwa ngokuvumelana "Nekhathalogi Yokuhlukaniswa Kwedivayisi Yezokwelapha", lesi simemezelo sibandakanya ushintsho kufayela lokubhaliswa komkhiqizo kufanele sikhonjiswe kukholamu yamazwana ngemva kokusetshenziswa kwesimemezelo sesigaba sokuphathwa komkhiqizo.
(C) iminyango yokuqondisa izidakamizwa kuwo wonke amaleveli ukuze kuqiniswe ukulungiswa kokuqukethwe “Kwekhathalogi Yedivayisi Yezokwelapha” yokukhangisa nokuqeqeshwa, futhi yenze ngempumelelo umsebenzi omuhle ohlobene nokubuyekezwa nokugunyazwa komkhiqizo, ukugcwalisa nokugadwa kwangemva kwemakethe.
Isikhathi sokuthumela: Aug-24-2023