Ngemva kweminyaka emibili yokulungiselela, i-Beijing Lingze Medical ithole ngempumelelo I-Medical Device Marketing Authorization (MDMA) ku-Saudi Arabia's Food and Drug Authority (SFDA) ngoJuni 25, 2025. Lokhu kugunyazwa kuhlanganisa ulayini wethu ogcwele womkhiqizo, okuhlanganisa ama-catheter e-PICC, amaphampu okuphakelayo, amasethi okuphakelayo, izikhwama ze-TPN, kanye nesinyathelo esibalulekile sokukhulisa i-nasoga yethu.
Iziphathimandla ezilawula idivayisi yezokwelapha e-Saudi Arabia yi-Saudi Food & Drug Authority (SFDA), enesibopho sokulawula, ukugada, nokuqapha ukudla, imithi, namadivayisi ezokwelapha, kanye nokusungula izindinganiso eziyisibopho zazo. Imishini yezokwelapha ingathengiswa kuphela noma isetshenziswe e-Saudi Arabia ngemva kokubhaliswa ne-SFDA nokuthola Ukugunyazwa Kokuthengisa Kwedivayisi Yezokwelapha (MDMA).
I-Saudi Food and Drug Authority (SFDA) idinga abakhiqizi bemishini yezokwelapha ukuthi baqoke Ummeleli Ogunyaziwe (i-AR) ozosebenza egameni labo emakethe. I-AR isebenza njengokuxhumana phakathi kwabakhiqizi bangaphandle kanye ne-SFDA. Ukwengeza, i-AR inesibopho sokuthobela umkhiqizo, ukuphepha, izibopho zangemuva kwemakethe, nokuvuselelwa kokubhaliswa kwedivayisi yezokwelapha. Ilayisense ye-AR evumelekile ibalulekile ekukhishweni kwempahla ngesikhathi sokungenisa umkhiqizo.
Njengoba isitifiketi sethu se-SFDA sesikhona manje, i-L&Z Medical isilungele ngokugcwele ukuhlinzeka izikhungo zezempilo zaseSaudi ngomugqa wethu ophelele wemikhiqizo yezokwelapha. Hlala ubukele ukuze uthole izibuyekezo ezengeziwe njengoba siqhubeka nokwandisa ubukhona bethu emakethe yaseMpumalanga Ephakathi.
Isikhathi sokuthumela: Jun-25-2025