Haiyan Kangyuan Medical Chimbo Co., Ltd. yakabudirira kuwana EU medical Instruments mirau (EU 2017/745, inonzi "MDR") chitupa musi waKukadzi 1, 2023, nhamba yechitupa ndeye 6122159CE01, uye chiyero chechitupa chinosanganisira Endotracheal Tubes yeKushandisa Kamwechete, Sterile Suction Mask Mask, O Sixy Suction Mask Sese Oxygen Cannulas yeKushandisa Kamwechete, Guedel Airways yeKushandisa Kamwechete, Laryngeal Mask Airways, Anesthesia Masks eKushandisa Kamwechete, Mafirita ekufema eKushandisa Kamwechete, Masekete ekufema eKushandisa Kamwechete.

Zvinonzi EU Medical Instrument Regulation MDR (EU 2017/745) yakatanga kushanda muna Chivabvu 25, 2017, ichitsiva Medical Instrument Directive MDD (93/42/EEC) uye Active Implantable Medical Instrument Directive AIMDD (90/385/EEC) veruzhinji nevarwere. Pakati pavo, MDR yakaisa pamberi zvakaomesesa zvinodiwa kune vagadziri vezviridzwa zvekurapa maererano nekutonga kwenjodzi yechigadzirwa, kuita kwechigadzirwa uye kuchengetedza mwero, kuongororwa kwekiriniki, uye mushure memusika chenjedzo uye kutarisa. Kuenzaniswa neiyo MDD kuraira, iyo inodzora MDR ine tarisiro yakasimba, yakanyanya kuoma chitupa, uye inobhadhara zvakanyanya kuchengetedzeka uye kushanda kwezvigadzirwa.

Kangyuan Medical yakabudirira kuwana chitupa cheMDR panguva ino, izvo zvinonyatsoratidza kuti Kangyuan zvigadzirwa zvasvika pakuzivikanwa kweEU nemisika yepasirese maererano nekutonga kwekugadzira, kuvimbiswa kwemhando uye manejimendi enjodzi.

KuKangyuan Medical, iyo yave ichibatanidzwa zvakanyanya mumusika weEurope kwemakore anopfuura gumi, kutorwa kwechitupa cheMDR chiitiko chakakosha. , Latin America nedzimwe misika dzakapa rubatsiro rwakasimba.