Ukwenzela ukwenza nzulu ngakumbi uhlaziyo lophononongo lwesixhobo sonyango kunye nenkqubo yokwamkelwa, esekwe kuphuhliso loshishino lwezixhobo zonyango kunye nolawulo olululo kunye nolawulo lwezixhobo zonyango, ngokuhambelana “neMimiselo yoLawulo noLawulo lweZixhobo zonyango” , "IiKhathalogu zoHlelo lweZixhobo zeMedical Iinkqubo zeDynamic Adjustment Work", i-State Drug Administration iye yagqiba ekubeni ilungelelanise ezinye zezinto eziqulethwe "I-Classification Catalog of Medical Devices".Imiba echaphazelekayo ibhengezwa ngolu hlobo lulandelayo:
Ukulungelelaniswa kweeklasi ze-58 zezixhobo zonyango ezinxulumene nomxholo we "Ikhathalogu yoHlelo lweSixhobo seMedical", uhlengahlengiso oluthile luboniswe kwisihlomelo.
Iimfuneko zokuPhumeza
(I) Ulungelelwaniso kwiSihlomelo esinxulumene ne-01-01-03 "izixhobo zotyando lwe-ultrasonic" kwi "intloko ye-ultrasonic cutting kunye ne-hemostasis, intloko ye-ultrasonic soft tishu yokuhlinzwa, intloko ye-ultrasonic suction suction" kunye ne-01-01-06 "isifuba Inkqubo ye-rotary excision biopsy kunye nezincedisi ezilawulwa njengezixhobo zonyango ze-Class III, ukususela kumhla wokupapashwa kwesi sibhengezo, isebe lolawulo lwamachiza liya, ngokuhambelana “noBhaliso lweSixhobo soNyango kunye neZincedisi”, “inaliti yokuhlatywa kwamabele kunye izixhobo”.Inkqubo ye-Breast rotary excision biopsy kunye nezincedisi "kwi-Breast rotary puncture iinaliti kunye nezixhobo", ukusukela ngomhla wesi sibhengezo, ulongamelo lwamachiza kunye namasebe olawulo ngokuhambelana "noBhaliso lweSixhobo seMedical kunye nemilinganiselo yoLawulo lokuFayila" "KwiSibhengezo iiMfuno zokuBhaliswa kweZixhobo zoNyango kunye neFomathi yoXwebhu lokuVuma” njalo njalo.Isibhengezo kuPapasho lweeMfuno zoBhaliso lweSixhobo sezoNyango kunye neFomathi yoXwebhu lokuVuma”, njl. njl., isebe lolawulo lwamachiza liya kusamkela isicelo sokubhaliswa kwezixhobo zonyango ngokodidi oluhlengahlengisiweyo.
Kuba isaziso samkelwe ngaphambi kokugqitywa kwemvume yobhaliso (kubandakanywa nokubhaliswa kokuqala kunye nokuqhubeka nokubhaliswa) kwezixhobo zonyango, ukulawulwa kweziyobisi kunye namasebe olawulo aqhubeka nokuhlaziya kunye nokuvunywa ngokuhambelana nokwamkelwa kokuqala kwecandelo, ukubhaliswa kunikezelwe, ukukhutshwa kwesatifikethi sobhaliso lwesixhobo sonyango, esilinganiselweyo kwisiqinisekiso sokubhaliswa kwezixhobo zonyango ngomhla wokugqibela kaDisemba 31, 2025, kunye nakwikholam yesatifikethi sobhaliso emva kohlengahlengiso lodidi lolawulo lwemveliso.Kuba ufumene isatifikethi sobhaliso lwezixhobo zonyango lweClass II, ngaphambi kwe-31 kaDisemba, isiqinisekiso sokubhaliswa kwemveliso ye-2025 siyaqhubeka sisebenza, umbhalisi kufuneka athathe inxaxheba ngokuhambelana neemfuno ezifanelekileyo zodidi oluhambelanayo lolawulo ukwenza ukuguqulwa kobhaliso ngenkuthalo. isatifikethi, ngaphambi kwe-31 kaDisemba 2025 ukugqiba uguqulo.Yenza umsebenzi wokuguqula ngexesha lesiqinisekiso sobhaliso lwesixhobo sonyango sokuqala siphelelwa, kukhuseleko lwemveliso kwaye lusebenza kwaye ludweliswe kwisiseko sokungabikho kweziganeko ezimbi kakhulu okanye iingozi ezisemgangathweni, umbhalisi unokuhambelana neempawu zolawulo lwangaphambili kunye neendidi ukuya ekuqaleni. isebe lemvume yokwenza isicelo sokwandiswa, ukuba kwandiswe, ukuba semthethweni kwesiqinisekiso sobhaliso lwesixhobo sonyango sokuqala akusayi kuba ngaphezu kwe-31 kaDisemba 2025.
Ukususela ngomhla we-1 kaJanuwari 2026, ezo mveliso aziyi kuveliswa, zithengiswe ngaphandle kwaye zithengiswe ngaphandle kokufumana isatifikethi sokubhalisa kwi-Class III yezixhobo zonyango ngokuhambelana nomthetho.Abavelisi abafanelekileyo kufuneka baphumeze ngokufanelekileyo uxanduva oluphambili lomgangatho wemveliso kunye nokhuseleko lokuqinisekisa ukhuseleko kunye nokusebenza kakuhle kweemveliso ezidwelisiweyo.
(B) ukulungelelaniswa komxholo wezinye iimveliso, ukususela kumhla wokupapashwa kwesi sibhengezo, ukulawulwa kweziyobisi kunye namasebe olawulo ngokusekelwe "kuBhaliso kunye nokuFakwa kweZixhobo zoNyango" "kwisibhengezo seemfuno zokubhaliswa kwezixhobo zonyango." ukuvakalisa ulwazi kunye nokuvunywa kwefomathi yoxwebhu" "ekufayilweni kwezixhobo zonyango zeClass I kwisaziso semiba echaphazelekayo" njalo njalo, ngokuhambelana necandelo elihlengahlengisiweyo ukwamkela isicelo sokubhaliswa kwezixhobo zonyango okanye ukwenzela irekhodi.
Kuba okwamkelweyo akukagqibi imvume yobhaliso (kubandakanywa ubhaliso lokuqala kunye nohlaziyo lobhaliso) lwezixhobo zonyango, ulongamelo lweziyobisi kunye namasebe olawulo ayaqhubeka nokuphonononga kunye nokwamkelwa ngokuhambelana nenqanaba lokuqala lokwamkelwa, ukubhaliswa kunikezelwe, ukukhutshwa isatifikethi sobhaliso lwesixhobo sonyango, nakwikholamu yesatifikethi sobhaliso emva kohlengahlengiso lodidi lolawulo lwemveliso.
Kwizixhobo zonyango ezibhalisiweyo, udidi lwayo lolawulo ukusuka kwiklasi yesithathu ehlengahlengisiweyo ukuya kwiklasi yesibini, isatifikethi sokubhaliswa kwesixhobo sonyango ngexesha lokuqinisekisa siyaqhubeka sisebenza.Ukuba ufuna ukuqhubeka, obhalisileyo kufuneka abe kwisiqinisekiso sobhaliso lwesixhobo sonyango siphela kwiinyanga ezi-6 phambi komhla wokuphelelwa, ngokuhambelana necandelo emva kotshintsho kwisebe elifanelekileyo leziyobisi kunye nolawulo lokufaka isicelo sohlaziyo lobhaliso, linikwe uhlaziyo. yobhaliso, ngokuhambelana nodidi oluhlengahlengisiweyo lolawulo lwemveliso olukhutshwe sisiqinisekiso sobhaliso lwesixhobo sonyango.
Kwizixhobo zonyango ezibhalisiweyo, udidi lwayo lolawulo ukusuka kwiklasi yesibini ehlengahlengisiweyo ukuya kwiklasi yokuqala, isatifikethi sokubhaliswa kwesixhobo sonyango kwixesha elisemthethweni liyaqhubeka lisebenza.Ngaphambi kokuphela kwesatifikethi sokubhalisa, umntu obhalisiweyo unokufaka isicelo serekhodi yemveliso kwisebe elihambelanayo.
Isatifikethi sobhaliso lwesixhobo sonyango ngaphakathi kokuqinisekiswa kotshintsho lobhaliso, obhalisiweyo uya kufaka isicelo kwisebe lobhaliso lokuqala ukutshintsha ubhaliso.Ukuba isatifikethi sobhaliso sokuqala sikhutshwe ngokuhambelana ne-original "I-Medical Classification Catalog", esi sibhengezo sibandakanya utshintsho kwifayile yokubhaliswa kwemveliso kufuneka iboniswe kwikholamu yamanqaku emva kokuphunyezwa kokubhengezwa kwecandelo lolawulo lwemveliso.
(C) amasebe olawulo lweziyobisi kunye nolawulo kuwo onke amanqanaba ukomeleza "Ikhathalogu yoLwahlulo lweSixhobo seMedical" ukulungiswa komxholo wokupapashwa kunye noqeqesho, kwaye ngokufanelekileyo wenze umsebenzi omhle onxulumene nokuhlaziywa kwemveliso kunye nokuvunywa, ukufayila kunye nokulawula emva kokuthengisa.
Ixesha lokuposa: Aug-24-2023