I-Haiyan Kangyuan Medical Insimbi I-Co., Ltd. ithole ngempumelelo isitifiketi se-EU Medical Instruments (EU 2017/745, esibizwa ngokuthi “MDR”) ngoFebhuwari 1, 2023, inombolo yesitifiketi ithi 6122159CE01, kanye nobubanzi besitifiketi buhlanganisa Amashubhu e-Endotracheal Okusetshenziswa Okukodwa, I-Sterle Suction Catheter yokusetshenziswa okukodwa, Imaski Yomoya-mpilo Yokusetshenziswa Kanye, Ama-Cannula Oksijini Wamakhala Okusetshenziswa Ngawo kanye, I-Guedel Airways yokusebenzisa Okukodwa, I-Laryngeal Mask Airways, Imaski Yokubulala Izinzwa Ukusetshenziswa Okukodwa, Izihlungi Zokuphefumula Zokusetshenziswa Okukodwa, Amasekhethi Okuphefumula Okusetshenziswa Okukodwa.

Kubikwa ukuthi i-EU Medical Instrument Regulation MDR (EU 2017/745) iqale ukusebenza ngoMeyi 25, 2017, ingena esikhundleni se-Medical Instrument Directive MDD (93/42/EEC) kanye ne-Active Implantable Medical Instrument Directive AIMDD (90/385) /EEC ), ehlose ukusungula uhlaka lokulawula lwesimanje noluqinile ukuze kuvikelwe kangcono impilo nokuphepha komphakathi neziguli. Phakathi kwazo, i-MDR ibeke phambili izidingo eziqinile kubakhiqizi bezinsimbi zezokwelapha mayelana nokulawulwa kwengozi yomkhiqizo, ukusebenza komkhiqizo namazinga okuphepha, ukuhlolwa komtholampilo, kanye nesexwayiso nokugadwa kwangemva kwemakethe. Uma kuqhathaniswa nomyalelo we-MDD, i-MDR elawulayo inokugada okunamandla, izitifiketi ezinzima kakhulu, futhi inaka kakhulu ukuphepha nokusebenza ngempumelelo kwemikhiqizo.

I-Kangyuan Medical ithole ngempumelelo isitifiketi se-MDR kulokhu, okufakazela ngokugcwele ukuthi imikhiqizo ye-Kangyuan isifinyelele ukuqashelwa kwe-EU kanye nezimakethe zamazwe ngamazwe mayelana nokulawulwa kokukhiqiza, ukuqinisekiswa kwekhwalithi kanye nokulawulwa kobungozi.

Ku-Kangyuan Medical, osekuyiminyaka engaphezu kweshumi ebambe iqhaza ngokujulile emakethe yaseYurophu, ukuthengwa kwesitifiketi se-MDR kuyingqopha-mlando. , I-Latin America nezinye izimakethe zinikeze ukusekelwa okuqinile.