Le ' Regulations on the Supervision on the Supervision and Administration of Medical Devices ' ( State Council Decree No.739, emva koku ekubhekiswa kuyo njenge ' Regulations ' emitsha ) iya kusebenza ngoJuni 1,2021.I-National Drug Administration iququzelela ukulungiswa kunye nohlaziyo lwemimiselo exhasayo, amaxwebhu aqhelekileyo kunye nezikhokelo zobugcisa, eziza kupapashwa ngokuhambelana neenkqubo.Izaziso ezingokuphunyezwa kwe ' Regulations ' emitsha zezi zilandelayo :
1. Ekuphunyezweni ngokupheleleyo kokubhaliswa kwesixhobo sonyango, inkqubo yokufayilisha
Ukususela ngomhla woku-1 kuJuni, ngo-2021, onke amashishini kunye namaziko ophuhliso lwezixhobo zonyango aphethe izatifikethi zobhaliso lwezixhobo zonyango okanye aphethe ukufayilishwa kwezixhobo zonyango zoDidi I-I ziya kuthi, ngokungqinelana namagatya eMithetho emitsha, zizalisekise izibophelelo zababhalisi bezixhobo zonyango kunye neefayili. ngokulandelelanayo, ukomeleza ulawulo lomgangatho wezixhobo zonyango kuwo wonke umjikelo wobomi, kwaye uthathe uxanduva lokhuseleko kunye nokusebenza kwezixhobo zonyango kuyo yonke inkqubo yophando, imveliso, ukusebenza kunye nokusetyenziswa ngokomthetho.
2. Kubhaliso lwesixhobo sonyango, ulawulo lokufayilisha
Ukususela ngomhla woku-1 kuJuni, i-2021, ngaphambi kokukhululwa kunye nokuphunyezwa kwemimiselo echaphazelekayo ekubhaliseni nasekufakweni 'kweMimiselo' emitsha, abafaki-zicelo zokubhaliswa kwezixhobo zonyango kunye neefayili baqhubeka befaka isicelo sokubhaliswa kunye nokufakwa ngokuhambelana nemimiselo yangoku.Iimfuno zovavanyo lweklinikhi yezixhobo zonyango ziya kuphunyezwa ngokuhambelana neNqaku lesi-3 lesi sibhengezo.Isebe lolawulo lweziyobisi liqhuba umsebenzi onxulumene nobhaliso kunye nokufayilisha ngokuhambelana neenkqubo zangoku kunye nemida yexesha.
3. Ukulawulwa koVavanyo lweKlinikhi yeZixhobo zoNyango
Ukusukela nge-1 kaJuni ka-2021, abafaki-zicelo ababhalise kwizixhobo zonyango kunye nabafake izicelo baya kuqhuba uvavanyo lwezonyango ngokuhambelana 'neMimiselo' emitsha.abo bathobela izibonelelo ze ' Regulations ' emitsha banokungabandakanywa kuvavanyo lwezonyango ;uvavanyo lweklinikhi lunokusekelwe kwiimpawu zemveliso, umngcipheko weklinikhi, idatha yeklinikhi ekhoyo, njl., ngokusebenzisa izilingo zeklinikhi, okanye ngeentlobo ezifanayo zezixhobo zonyango uncwadi lwekliniki, uhlalutyo lwedatha yeklinikhi kunye nokuvavanya ukubonisa ukuba izixhobo zonyango zikhuselekile kwaye ziyasebenza;uncwadi lwekliniki olukhoyo, idatha yeklinikhi ayanelanga ukuqinisekisa ukhuseleko lwemveliso, izixhobo zonyango ezisebenzayo, kufuneka ziqhube iimvavanyo zekliniki.Ngaphambi kokukhululwa kunye nokuphunyezwa kwamaxwebhu afanelekileyo akhululwe kuvavanyo lweklinikhi, uluhlu lwezixhobo zonyango ezikhululiwe kuvavanyo lweklinikhi luphunyezwa ngokubhekiselele kuluhlu lwangoku lwezixhobo zonyango ezixolelwe kwizilingo zeklinikhi.
4.Mayela nelayisenisi yokuvelisa isixhobo sonyango, ulawulo lokufayilisha
Ngaphambi kokukhululwa kunye nokuphunyezwa kwezibonelelo ezifanelekileyo 'zeMithetho' emitsha exhasa iilayisenisi zemveliso kunye nokufakwa, ababhalisi bezixhobo zonyango kunye nabafaki zicelo baphatha iilayisenisi zokuvelisa, ukufakwa kunye nokuveliswa kwemveliso ngokuhambelana nemimiselo ekhoyo kunye namaxwebhu aqhelekileyo.
5.Kwilayisenisi yeshishini lesixhobo sonyango, ulawulo lokufayilisha
Isixhobo sonyango esibhalisiweyo okanye esibhaliswe sisixhobo sonyango esibhalisiweyo okanye esibhalisiweyo ngumntu othengisa isixhobo sonyango esibhalisiweyo okanye esibhaliswe kwindawo ahlala kuyo okanye idilesi yokuvelisa asifuni layisensi yoshishino yesixhobo sonyango okanye ubhaliso, kodwa siya kuthobela imiqathango yokusebenza emiselweyo;ukuba uhlobo lwesibini nolwesithathu lwezixhobo zonyango zigcinwe kwaye zithengiswa kwezinye iindawo, ilayisenisi yeshishini lesixhobo zonyango okanye irekhodi kufuneka iqwalaselwe ngokuhambelana nezibonelelo.
I-State Drug Administration iye yaqulunqa ikhathalogu yodidi lwe-II yeemveliso zezixhobo zonyango ezixolelwe ekubhaliseni ishishini kwaye ifuna iingcebiso zoluntu.Emva kokuba ikhathalogu yemveliso ikhutshwe, landela ikhathalogu.
6.Uphando kunye nesohlwayo sokuziphatha okungekho mthethweni kwesixhobo zonyango
Ukuba ukuziphatha okungekho mthethweni kwezixhobo zonyango kwenzeke ngaphambi komhla woku-1 kuJuni, ngo-2021, kuya kusetyenziswa “iMimiselo” phambi kohlaziyo.Nangona kunjalo, ukuba "iMithetho" emitsha ibona ukuba akukho mthethweni okanye isohlwayo silula, "iMithetho" emitsha iya kusetyenziswa.Kusebenza 'iMigaqo' emitsha apho ulwaphulo-mthetho lwenzeke emva komhla woku-1 kuJuni ngo-2021.
Iyabhengezwa ngolu hlobo.
Ulawulo lweziyobisi lweSizwe
Meyi 31, 2021
Ixesha lokuposa: Jun-01-2021