NgoJuni 21, 2017, i-China FDA imemezele i-14^thisaziso sekhwalithi yemishini yezokwelapha kanye nokugadwa kwekhwalithi okushicilelwe nesimo sokuhlolwa kwesampula sezigaba ezi-3 247 amasethi emikhiqizo efana namashubhu oqhoqhoqho alahlwayo, ithemometha yezokwelapha yezokwelapha njll.

Amasampula ahlolwe ngokungahleliwe angahlangabezani nezindinganiso zemishini yezokwelapha ehilela izigaba ezi-3 zesethi yemikhiqizo ekhiqizwe abakhiqizi bemishini yezokwelapha emi-4; izinto ezihloliwe njengokuhlonza amalebula, izincwajana njll ezingahlangabezani nezindinganiso ziyisigaba esi-1 sesethi yemishini yezokwelapha ekhiqizwe abakhiqizi aba-2 bemishini yezokwelapha; Izigaba ezi-3 241 amasethi amathuluzi wezokwelapha akhiqizwa abakhiqizi bemishini yezokwelapha abangama-92 bahlangabezana nezindinganiso ezifanele zazo zonke izinto ezihloliwe.

Njengamanje, uMnyango Wezokudla Nezidakamizwa kuzwelonke usuvele ucele iminyango yendawo ebhekele ukudla nezidakamizwa kanye nokuphatha ukuthi iphenye futhi ibhekane nezinkampani ezifanele, futhi yacela iminyango efanele yesifundazwe ebhekele ukudla nezidakamizwa nokuphatha ukuthi imemezele ukuchithwa kwesimo emphakathini. .

Ukuze kuqiniswe ukugadwa kwekhwalithi nokuphathwa kwemishini yezokwelapha futhi kuqinisekiswe ukusetshenziswa okuphephile nokusebenzayo kwemishini yezokwelapha, i-FDA yethu kazwelonke muva nje yenza ukugada kwekhwalithi namasampula ngokuvumelana ngokuqinile nemvamisa ukuya esilinganisweni sezikhathi ezi-2 ngenyanga. Ifaka ngokugcwele ukukhathazeka kukahulumeni ngemishini yezokwelapha, kuyadingeka ukuthi uvivinye imakethe uma ufuna ukuqhubekela phambili kulo mgwaqo.

I-Shenzhen Med-link Medical Electronics Co., Ltd. ihlale idinga ukuthi yonke imikhiqizo ihlangabezane nezindinganiso zakamuva zikazwelonke nezamazwe ngamazwe. Njengoba yasungulwa ngo-2004, ngemva kokuhlela konyaka ongu-1, iqoqo lokuqala le-Med-link lekhebula le-ECG nezintambo eziholayo zaphumelela ukubhaliswa kwe-CFDA, kuyisiqalo esihle futhi kuwubufakazi obuhle kakhulu bemizamo yethu.

Ngemuva kocwaningo olusha lweminyaka engu-13 emkhakheni wemishini yezokwelapha ngo-2017, i-Med-link ithuthukiswe ngokuzimela izinga lokushisa, inzwa ye-SpO₂ esebenzisekayo, ipensela ye-ESU elahlwayo, intambo yokunweba ye-pulse SpO₂, i-electrode yobuchopho engahlaseli, ikhebula le-IBP njll. imikhiqizo iqinisekiswe ngokusemthethweni izinhlangano zamazwe ngamazwe njenge-CFDA, i-FDA, i-CE njll.

Ngokuhlangenwe nakho okuhlolwe isikhathi eside emakethe yemishini yezokwelapha, ngeke sizitike esikhathini esidlule, futhi ngeke simane sinyathele ngesinyathelo. Ukuzivumelanisa nezimo ezishintsha njalo emakethe yemishini yezokwelapha, ukuhlangabezana nezidingo zakamuva zamaqembu ahlukene, i-Med-link Medical izohlale iphishekela izindinganiso eziphakeme nobuchwepheshe obuphezulu, futhi ifakazele amandla ethu ngekhwalithi yomkhiqizo.

Ukuxhumanisa ukunakekelwa kwempilo nokunakekelwa, yenza abasebenzi bezokwelapha babe lula, abantu babe nempilo!