Ngomhla zizi-4 kuSepthemba 2017, i-State Food and Drug Administration (ngemuva kwalokhu ebizwa ngokuthi “Ukuphathwa Okujwayelekile”) yabamba umhlangano nabezindaba ukuze ikhulule ngokusemthethweni “Ikhathalogu Yokuhlukaniswa Kwamadivayisi Ezokwelapha” esanda kubuyekezwa (ngemuva kwalokhu ebizwa ngokuthi “Ikhathalogi Yokuhlukanisa ”).Iqala ukusebenza ngomhla ka-Agasti 1, 2018.
Ukuphathwa kwezigaba zedivayisi yezokwelapha kuyindlela yokuphatha eyamukelwa emhlabeni wonke, futhi ukuhlukaniswa kwemishini yezokwelapha ngokwesayensi nokunengqondo kuyisisekelo esibalulekile sokuqondisa yonke inqubo yokubhaliswa, ukukhiqizwa, ukusebenza nokusetshenziswa kwedivayisi yezokwelapha.
Njengamanje, kunezitifiketi zokubhaliswa kwemishini yezokwelapha ezingaba ngu-77,000 kanye nezitifiketi zokubhaliswa kwemishini yezokwelapha ezingaphezu kuka-37,000 e-China.Ngokuthuthuka okusheshayo kwemboni yemishini yezokwelapha kanye nokuvela okuqhubekayo kobuchwepheshe obusha nemikhiqizo emisha, uhlelo lokuhlukanisa idivayisi yezokwelapha alukwazanga ukuhlangabezana nezidingo zokuthuthukiswa kwezimboni nomsebenzi wokulawula.Inguqulo yango-2002 “Yekhathalogi Yokuhlukaniswa Kwedivayisi Yezokwelapha” (ngemuva kwalokhu ebizwa ngokuthi “Ikhathalogi Yokuhlukanisa” yasekuqaleni) Ukushiyeka komkhakha sekugqama kakhulu: Okokuqala, “Ikhathalogi Yokuhlukanisa” yoqobo ayinamininingwane eyanele, futhi i uhlaka lulonke kanye nokumiswa kwezinga akukwazi ukuhlangabezana nesimo samanje semboni nezidingo zokulawula.Okwesibili, “Ikhathalogu” yoqobo yayingenalo ulwazi olubalulekile olufana nencazelo yomkhiqizo kanye nokusetshenziswa okuhlosiwe, okuthinte ukufana nokumiswa kokugunyazwa kokubhaliswa.Okwesithathu, "Ikhathalogu Yesigaba" yasekuqaleni bekunzima ukumboza imikhiqizo emisha nezigaba ezintsha.Ngenxa yokuntuleka kwendlela yokulungisa eguqukayo, okuqukethwe kwekhathalogi akukwazanga ukubuyekezwa ngesikhathi, futhi ukuhlukaniswa kwesigaba somkhiqizo bekungalungile.
Ukuze kusetshenziswe “Imithethonqubo Yokwengamela Nokuphathwa Kwamadivayisi Ezokwelapha” ebuyekeziwe futhi yamenyezelwa UMkhandlu Wezwe kanye “Nemibono yoMkhandlu Wezwe Wokulungisa Ukubuyekeza Nokugunyazwa Kwesistimu Yezidakamizwa Namadivayisi Ezokwelapha”, Ukudla Nezidakamizwa Zombuso. Ukuphatha kuye kwafingqa ngokuphelele futhi kwahlaziya izisetshenziswa zezokwelapha ezikhishwe phakathi neminyaka ngokuhambisana nokusatshalaliswa kwezinguquko zokulawulwa kwezigaba zedivayisi yezokwelapha.Ukuhlelwa kwedivayisi namafayela ezincazelo, ukuhlunga ulwazi lwemikhiqizo evumelekile yokubhaliswa kwedivayisi yezokwelapha, nokucwaninga ukuphathwa kwemishini yezokwelapha efanayo yangaphandle.Umsebenzi wokubukeza wethulwa ngoJulayi 2015, futhi ukwenziwa ngcono sekukonke kanye nokulungiswa kohlaka, ukwakheka nokuqukethwe “Kwekhathalogi Yokuhlukanisa” kwenziwa.Setha Ikomidi Lobuchwepheshe Lokuhlukaniswa Kwedivayisi Yezokwelapha kanye neqembu lalo lochwepheshe, labonisa ngokuhlelekile isayensi nokuhluzeka kokuqukethwe “Kwekhathalogi Yokuhlukanisa”, futhi labuyekeza “Ikhathalogi Yokuhlukanisa” entsha.
“Ikhathalogi Yesigaba” entsha ihlukaniswe yaba izigaba ezincane ezingama-22 ngokuya nezici zobuchwepheshe bemishini yezokwelapha nokusetshenziswa komtholampilo.Izigaba ezincane zakhiwe izigaba zomkhiqizo wezinga lokuqala, izigaba zomkhiqizo wezinga lesibili, izincazelo zemikhiqizo, ukusetshenziswa okuhlosiwe, izibonelo zamagama emikhiqizo, nezigaba zokuphatha.Lapho kunqunywa isigaba somkhiqizo, ukuzimisela okuphelele kufanele kwenziwe ngokusekelwe esimweni sangempela somkhiqizo, kuhlanganiswe nencazelo yomkhiqizo, ukusetshenziswa okuhlosiwe kanye nezibonelo zegama lomkhiqizo “Kukhathalogi Yokuhlukanisa” entsha.Izici eziyinhloko ze "Ikhathalogi Yokuhlukanisa" zimi kanje: Okokuqala, isakhiwo singokwesayensi kakhulu futhi sihambisana kakhulu nokusebenza komtholampilo.Ukudweba izifundo ezivela ohlelweni lokuhlukanisa olugxile ekusetshenzisweni emtholampilo e-United States, kubhekiselwa esakhiweni “se-Framework Catalog for Notified Bodies of the European Union”, izigaba ezingaphansi ezingama-43 “zekhathalogi yokuhlukaniswa” yamanje zihlanganiswe zaba yizi-22. izigaba ezincane, kanye nezigaba zemikhiqizo ezingama-260 zicwengisisiwe futhi zalungiswa zaba yizigaba zemikhiqizo yezinga lokuqala ezingama-206 kanye nezigaba zemikhiqizo yezinga lesibili eziyi-1157 zakha isigaba sekhathalogi enamazinga amathathu.Okwesibili, ukufakwa kubanzi, kuyafundisa futhi kuyasebenza.Imikhiqizo emisha engaphezu kuka-2,000 yengezwe ukusetshenziswa okulindelekile nezincazelo zomkhiqizo, futhi "Ikhathalogi Yokuhlukanisa" yamanje inwetshiwe yaba izibonelo ezingu-6,609 zamagama emikhiqizo angu-1008.Okwesithathu ukulungisa ngokunengqondo izigaba zokuphathwa komkhiqizo, ukuthuthukisa ukuguquguquka kwesimo sembonini esikhona kanye nokugadwa kwangempela, nokuhlinzeka ngesisekelo sokuthuthukisa ukwabiwa kwezinsiza zokugada.Ngokwezinga lengozi yomkhiqizo kanye nokugadwa kwangempela, isigaba sokuphatha semikhiqizo yemishini yezokwelapha engama-40 enesikhathi eside sokumakethwa, ukuvuthwa okuphezulu komkhiqizo kanye nezingozi ezilawulekayo ziyancishiswa.
Uhlaka nokuqukethwe kwe-"Classification Catalogue" entsha kulungiswe kakhulu, okuzoba nomthelela kuzo zonke izici zokubhaliswa kwedivayisi yezokwelapha, ukukhiqizwa, ukusebenza, nokusetshenziswa.Ukuze kuqinisekiswe ukuqonda okuhlangene kwazo zonke izinhlangothi, uguquko olushelelayo, kanye nokuqaliswa okuhlelekile, i-State Food and Drug Administration kanyekanye yakhipha futhi yasebenzisa “Isaziso Sokusetshenziswa Kokusha Okubuyekeziwe.”, enikeza cishe unyaka wokusebenzisa isikhathi soshintsho.Ukuqondisa iziphathimandla ezilawulayo kanye namabhizinisi ahlobene ukuze aqalise.Mayelana nokuphathwa kokubhalisa, kucatshangelwa ngokugcwele isimo semboni yemishini yezokwelapha, ukwamukela isiteshi soshintsho lwemvelo ukuze kusetshenziswe “Ikhathalogi Yokuhlukanisa” entsha;ngokugadwa kwangemva kokumakethwa, ukugadwa kokukhiqiza nokusebenza kungasebenzisa amasistimu amakhodi wokuhlukanisa ngezigaba amasha kanye namadala ngokuhambisana.I-State Food and Drug Administration izohlela ukuqeqeshwa kohlelo lonke “Kukhathalogi Yokuhlukanisa” futhi iqondise iziphathimandla zendawo ezilawulayo nezinkampani ezikhiqizayo ukuze ziqalise “Ikhathalogi Yokuhlukanisa” entsha.
2018 ikhathalogi entsha yokuhlukanisa idivayisi yezokwelapha Umthombo wokuqukethwe: China Food and Drug Administration, http://www.sda.gov.cn/WS01/CL0051/177088.html
Isikhathi sokuthumela: Mar-02-2021