Ukuze uphinde ujulise ukuguqulwa kwe-Medical Ukubuyekezwa Kokubukeza Kokubukeza Kokubuyekezwa Kwedivaysi kanye nohlelo lokuvunyelwa, ngokususelwa ekuthuthukisweni komkhakha wedivayisi yezokwelapha kanye nokuphathwa kwangempela kanye nokuphathwa kwamadivaysi ezokwelapha, ngokuya nge- "Regulations ngokugadwa kwamadivayisi wezokwelapha" , "Amadivayisi we-Medicals Classification Clalogcation Clolog eguqukayo izinqubo zomsebenzi" Izindaba ezifanele zimenyezelwe kanjena:
Ukulungiswa kwamakilasi angama-58 amadivaysi ezokwelapha ahlobene nokuqukethwe "Ikhathalogi Yesigaba Sedivayisi yezokwelapha", izinguquko ezithile zikhonjiswa esijovwini.
Izidingo Zokuqalisa
. Uhlelo lwe-Rotary Excrision Biopsy kanye nezesekeli "ezilawulwa njengamadivaysi ezokwelashwa e-Class III, kusukela ngosuku lokushicilelwa kwalesi simemezelo, uMnyango Wezokuphathwa Kwezidakamizwa, ngokuhambisana" nezesekeli zokubhalwa kwedivayisi kanye " izesekeli ". Uhlelo lwe-Breatrary Rotary Excry System nezesekeli "" kuzinaliti ezijikelezayo zesifuba ezihamba phambili, ngoba usuku lwalesi simemezelo, ukubhekelwa kwezidakamizwa kanye nokubhaliswa kwezinto zokuphatha kanye nezindlela zokuphatha zezokwelapha "" ngokumenyezelwa kwe Izidingo zokubhaliswa kwamadivayisi wezokwelapha kanye nefomethi yodokhumenti wemvume "nokunye. Isimemezelo ekushicilelweni kwezidingo zokubhaliswa kwedivayisi yezokwelapha kanye nefomethi yokuvunyelwa kwedokhumenti ", njll.
Ukuze isimemezelo samukelwe ngaphambi kokuphothulwa kokuvunyelwa kokubhalisa (okubandakanya ukubhaliswa kokuqala nokuqhubeka kokubhaliswa) kwamadivayisi wezokwelapha, ukubhekwa kwezidakamizwa kanye nokuphathwa kwezidakamizwa kuyaqhubeka ukubukeza nokwamukelwa kokuqala kwesigaba, ukubhaliswa kuvunyelwe, Ukukhishwa kwesitifiketi sokubhaliswa kwedivayisi yezokwelapha, okukhawulelwe ekuqinisekisweni kwesitifiketi sokubhaliswa kwamadivaysi ezokwelapha ngomnqamulajuqu kaDisemba 31, 2025, nakwikholamu yokubhalisa ngemuva kokulungiswa kwesigaba sokuphathwa komkhiqizo. Ngoba ithole isitifiketi sokubhaliswa kwamadivaysi e-Class II, ngaphambi kukaDisemba 31, iSitifiketi sokubhaliswa komkhiqizo siyaqhubeka nokusebenza, obhalisile kufanele ahlanganyele ngokuya ngezidingo ezifanele zesigaba sokuphatha esihambisanayo sokuvuselelwa kokubhaliswa Isitifiketi, ngaphambi kukaDisemba 31, 2025 ukuqeda ukuguqulwa. Yenza umsebenzi wokuguqulwa ngesikhathi sesitifiketi sokubhaliswa kwedivayisi yasekuqaleni kwezokwelapha, ekuphepheni komkhiqizo kanye nangokusebenza ngempumelelo kwezehlakalo ezingezinhle noma izingozi zekhwalithi, obhalisile angahambisana nezimpawu zokuphatha zoqobo nezigaba zangempela Umnyango Wemvume Ukufaka isicelo sesandiso, ukunwetshwa, ukuba semthethweni kwesitifiketi sokubhaliswa kwensiza yoqobo yezokwelapha ngeke kube ngaphezu kukaDisemba 31, 2025.
Kusukela ngoJanuwari 1, 2026, imikhiqizo enjalo ngeke ikhiqizwe, ingeniswe futhi ithengiswe ngaphandle kokuthola isitifiketi sokubhaliswa samadivayisi wezokwelapha weklasi iii ngokuhambisana nomthetho. Abakhiqizi abafanelekayo kufanele basebenzise ngempumelelo umthwalo wemfanelo omkhulu wekhwalithi yomkhiqizo nokuphepha ukuze uqinisekise ukuphepha nokusebenza kahle kwemikhiqizo efakwe kuhlu.
(B) ngokulungiswa kokuqukethwe kweminye imikhiqizo, kusukela ngosuku lokushicilelwa kwalesi simemezelo, ukubhekwa kwezidakamizwa kanye nokuphathwa kwezidakamizwa ngokuya ngokuthi "ukubhaliswa kwamadivaysi ezokwelapha" Ukumemezela imininingwane nokuvunywa kwefomethi yedokhumenti "" Ekugcwalisweni kwama-Class I Medical Devices ekumemezelweni kwezindaba ezifanele "nokunye, ngokuya ngesigaba esilungisiwe ukwamukela uhlelo lokusebenza lwamadivayisi wezokwelapha noma ngerekhodi.
Kwabakwamukelekayo akukaqedi ukuvunyelwa kokubhalisa (okubandakanya ukubhaliswa kokuqala nokuvuselela ukubhaliswa) kwamadivayisi wezokwelapha, ukubhekwa kwezidakamizwa kanye nokuphathwa kwezidakamizwa kuyaqhubeka ukubukeza nokuvunywa ngokuhambisana nesigaba sokuqala sokwamukelwa, ukubhaliswa kuvunyelwe, ukukhishwa kwe Isitifiketi sokubhaliswa kwedivayisi yezokwelapha, kanye nekholamu yokubhaliswa kwesitifiketi ngemuva kokulungiswa kwesigaba sokuphathwa komkhiqizo.
Kumadivayisi wezokwelapha abhalisiwe, isigaba sawo sokuphatha esivela ekilasini lesithathu elilungiswe esigabeni sesibili, isitifiketi sokubhaliswa kwedivayisi yezokwelapha esinqumweni sokuqinisekiswa siqhubeka sisebenza. Uma udinga ukuqhubeka, obhalisile kufanele abe esitikweni sokubhaliswa kwe-Medical Service uphela isikhathi esingu-6 ngaphambi kosuku lokuphelelwa yisikhathi, ngokuya ngesigaba ngemuva koMnyango ofanelekayo wokuvuselelwa kwezidakamizwa kanye nokuvuselelwa kokubhalisa, ngokuya ngesigaba esilungisiwe sokuphathwa komkhiqizo okukhishwe isitifiketi sokubhaliswa kwedivayisi yezokwelapha.
Kumadivayisi wezokwelapha abhalisiwe, isigaba sayo sokuphatha esivela ekilasini lesibili elilungiswe ekilasini lokuqala, isitifiketi sokubhaliswa kwe-Medical Service esimweni sokuvunyelwa kwezokwelapha siyaqhubeka nokusebenza. Ngaphambi kokuphela kwesitifiketi sokubhaliswa, obhalisile angafaka isicelo serekhodi lomkhiqizo eMnyangweni ohambisanayo.
Isitifiketi sokubhaliswa kwedivayisi yezokwelapha ngaphakathi kokuphathwa kwezinguquko zokubhalisa, obhalisile azosebenza emnyangweni wokubhalisa wokuqala ukuze aguqule ukubhaliswa. Uma isitifiketi sokubhaliswa sokuqala sikhishwa ngokuya nge- "Medical Diffection Class Class Clalogy", lesi simemezelo sibandakanya ushintsho kufayela lokubhaliswa komkhiqizo kufanele likhonjiswe kwikholamu yokubhalisa komkhiqizo ngemuva kokuqaliswa kokumenyezelwa kwesigaba sokuphathwa komkhiqizo.
.
Isikhathi sePosi: Aug-24-2023