NgoJuni 21, 2017, iChina FDA imemezele le 14^thIsaziso sekhwalithi yamadivaysi ezokwelapha kanye nesimo sekhwalithi sokuhlola sekhwalithi kanye nesimo sesampula sokuhlola izigaba ezi-3 zemikhiqizo engama-247 sets

Amasampula ahlolwe ngokungahleliwe angahlangabezani namazinga wemishini yezokwelapha ehilela izigaba ezi-3 amasethi akhiqizwe ngabakhiqizi abangu-4 bezokwelapha; Izinto ezihloliwe ezinjengokukhonjwa kwamalebula, izincwajana njll hhayi ukuhlangabezana namazinga ayisikhombisa amasethi wezokwelapha 2 Set imishini yezokwelapha ekhiqizwa ngabakhiqizi bedivaysi yezokwelapha emi-2; Izigaba ezi-3 zibeka imishini yezokwelapha ekhiqizwe ngabakhiqizi bezokwelapha abangama-92 bezokwelashwa bahlangabezana namazinga afanele kuzo zonke izinto ezihloliwe.

Njengamanje, ukudla okuphathelene nezidakamizwa kanye nokuphathwa kwezidakamizwa sekuvele kucelile ukudla kwasendaweni kanye neminyango yokuphatha ukuphenya kanye nokubhekana namabhizinisi afanelekile kanye nokuphathwa kwezidakamizwa ukumemezela isimo sokulahlwa kwesimo emphakathini .

Ukuze uqinise ukuphathwa kwekhwalithi kanye nokuphathwa kwemishini yezokwelapha futhi uqinisekise ukusetshenziswa okuphephile futhi okusebenzayo kwemishini yezokwelapha, i-FDA yethu kazwelonke isanda kwenza ukugadwa kwekhwalithi kanye nesampula ngokuqinile ngokuya ngesilinganiso esingu-2 izikhathi ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga ngenyanga. Ifaka ngokugcwele ukukhathazeka kukahulumeni ngemishini yezokwelapha, kuyadingeka ukumelana nokuhlolwa kwemakethe uma ufuna ukuya phambili kulo mgwaqo.

I-Shenzhen Med-Link Electronics Co, Ltd. ihlala idinga yonke imikhiqizo ihlangabezane namazinga wakamuva kazwelonke nawamazwe aphesheya. Njengoba yasungulwa ngo-2004, ngemuva kokuhlelwa konyaka ongu-1, i-watch yokuqala ye-ECG Cable kanye ne-Lead Wires yadlula ukubhaliswa kwe-CFDA ngempumelelo, kuyisiqalo esihle futhi nobufakazi obuhle kakhulu bemizamo yethu.

Ngemuva kweminyaka engu-13 ucwaningo olusha emkhakheni wezinto zokwelashwa ngonyaka we-2017, i-Med-Link-Link Prose, inzwa ye-SPO₂ evuselelwayo, i-Punse Pencil Cable, i-Electrode ye-Parse Brain Etc, lonke lolu chungechunge lwe Imikhiqizo iqinisekiswe ngokugunyaziwe yizinhlangano zomhlaba wonke ezifana neCFDA, FDA, CE njll.

Ngomuzwa ohlolwe isikhathi eside emakethe yezemishini yezokwelapha, ngeke singene esikhathini esedlule, futhi futhi ngeke simane sinyathelo ngesinyathelo. Ukuzivumelanisa nokushintsha njalo emakethe yemishini yezokwelapha, okuhlangabezana nezidingo zakamuva zamaqembu ahlukene, i-Med-Link Medical izohlala iphishekela amazinga aphezulu nobuchwepheshe obuphezulu, bese ifakazela amandla ethu ngekhwalithi yomkhiqizo.

Ukuxhuma Ukunakekelwa Kwempilo Ngokunakekelwa, yenza abasebenzi bezokwelapha kube lula, abantu banempilo!