Njalo ngonyaka, i-National Medical Products Administration (NMPA) yaseShayina ihola umkhankaso kazwelonke — i-Medical Device Safety Week — ihlanganisa abakhiqizi, abalawuli, kanye nochwepheshe bezempilo ngesimiso esisodwa esihlanganyelwe: ukuphepha kwamadivayisi akunakuxoxiswana ngaso. Kumkhiqizi wokukhanyisa okuhlinzwa onjengeMicare, leso simiso asiyona into engaqondakali. Sihlala kuwo wonke amamojula e-LED esiwakhethayo, kuwo wonke ukuhlolwa kokukhanya esikwenzayo, nakuwo wonke amalambu e-OR esiwathumelayo.
Indlunkulu yayo eNanchang, eJiangxi, iMicare isichithe iminyaka engaphezu kwamashumi amabili iklama futhi ikhiqizaizibani zokukhanyisa ezihlinzayofuthiizibani zegumbi lokuhlinza. Lokhu akuyona imikhiqizo yezimpahla. Ikhono likadokotela ohlinzayo lokuhlukanisa izinhlaka zezicubu ngaphansi komsebe ongu-6,500K — ngaphandle kokucindezeleka kwamehlo ngemva kwenqubo yamahora ayisithupha — lincike kumingcele abathengi abaningi abangayiboni: ukufana kokukhanya, ukuqina kokubonisa umbala, kanye nokusebenza kokuxuba izithunzi.
Yilapho ukukhiqiza okulawulwayo kwenza khona umehluko. I-Micare isebenza ngaphansi kwe-Isitifiketi se-ISO 13485, ngezibani zokuhlinzwa eziphethe uphawu lwe-CE kanye nokubhaliswa kwe-FDA. Yonke iyunithi ephuma esikhungweni sethu idlula ukuhlolwa kokukhanya okunamaphoyinti amaningi. Ukulandelela kwezingxenye ze-batch kugcinwa kusukela ekuqaleni kuya ekugcineni — hhayi ngoba umhloli wezincwadi ekudingayo, kodwa ngoba zonke izibani zokuhlinzwa esizithumelayo zinomthwalo wemfanelo ongashiyi ndawo yezinqamuleli.
Isimo sokuthobela imithetho siyaqina. Umkhuba Wokukhiqiza Omuhle we-NMPA obuyekeziwe we-Amadivayisi Ezokwelapha, eyanyatheliswa ngasekupheleni kuka-2025, iqala ukusebenza ngokugcwele ngoNovemba 2026. Lokhu kubuyekezwa kuletha izidingo eziqinile phakathi kokulawulwa komklamo, ukuqinisekiswa kwenqubo yokukhiqiza, kanye nokubhekwa ngemuva kwemakethe. I-Micare isivele iqalile ukuhlolwa okugcwele kwemibhalo yayo yekhwalithi ngokumelene nendinganiso entsha - ngaphambi kwesikhathi esinqunyiwe sokuphoqelelwa.
Kwabalingani bethu bokusabalalisa emhlabeni wonke kanye nabasebenzisi bokugcina, lokhu kubalulekile ngokwemibandela esebenzayo: ukuvunyelwa kwentela okufushane, ukubambezeleka okuncane kokuhlolwa, kanye namarekhodi ekhwalithi alandelekayo amelana nokuhlolwa yinoma yimuphi umkhandlu olawulayo.
Iviki Lokuphepha Kwamadivayisi Ezokwelapha, ngokuyinhloko, liyisikhumbuzo. Kodwa kubakhiqizi abalithatha ngokungathi sína, futhi liyindawo yokuhlola — isikhathi sokubuza ukuthi izinhlelo ezithole izitifiketi zangozolo zisasebenza kahle yini ezindinganisweni zakusasa. KwaMicare, sihlose ukuqhubeka siphendula ngokuthi yebo.
Isikhathi sokuthunyelwe: Julayi-08-2026