Iuni 21, 2017, Saina FDA faalauiloa le 14^thfa'aaliga o le lelei o masini fa'afoma'i ma fa'asalalau lelei le va'ava'aiga & fa'ata'ita'iga fa'ata'ita'iga tulaga o 3 vaega 247 seti oloa e pei o fa'alava fa'apalapala, fa'aeletonika vevela fa'afoma'i ma isi.

Fa'ata'ita'iga su'esu'e fa'afuase'i e le'o fa'amalieina fa'ata'ita'iga o mea faigaluega fa'afoma'i e aofia ai vaega e 3 4 seti oloa na gaosia e 4 tagata gaosi mea faigaluega fa'afoma'i; o mea na asiasia e pei o fa'ailoga fa'ailoga, fa'asalalauga ma isi e le'o ausia tulaga fa'ata'atia e 1 vaega 2 seti meafaigaluega fa'afoma'i na gaosia e le 2 gaosi masini fa'afoma'i; 3 categories 241 seti meafaigaluega faʻafomaʻi na gaosia e 92 masini faʻafomaʻi gaosi oloa e fetaui ma tulaga talafeagai mo mea uma na asiasia.

I le taimi nei, ua uma ona talosagaina e le National Food and Drug Administration le vaavaaia o meaʻai ma vailaʻau faʻapitonuʻu ma le pulega o matagaluega e suʻesuʻe ma faʻatautaia pisinisi talafeagai, ma talosagaina le matagaluega talafeagai o meaʻai ma vailaʻau ma pulega e faʻasalalau le lafoaia o le tulaga i tagata lautele. .

Ina ia faʻamalosia le lelei o le vaavaaiga ma le puleaina o meafaigaluega faʻafomaʻi ma faʻamautinoa le saogalemu ma le aoga o le faʻaogaina o meafaigaluega faʻafomaʻi, o le matou FDA talu ai nei na faia ai le vaavaaiga lelei ma le faʻataʻitaʻiga e tusa ai ma taimi masani i le averesi o le 2 taimi i le masina. O lo'o fa'atusaina atoatoa ai le atugaluga o le malo mo mea faigaluega fa'afoma'i, e mana'omia le tu'u i le su'ega a le maketi pe afai e te mana'o e alu mamao atu i lenei auala.

Shenzhen Med-link Medical Electronics Co., Ltd. e manaʻomia i taimi uma oloa uma ina ia ausia tulaga lata mai a le atunuʻu ma faavaomalo. Talu ai na faavaeina i le 2004, ina ua maeʻa le 1 tausaga o fuafuaga, o le vaega muamua a Med-link o le ECG cable ma taʻitaʻia uaea na pasia ma le manuia le resitalaina o le CFDA, o se amataga lelei ma o le faʻamaoniga sili foi oa tatou taumafaiga.

Ina ua mavae le 13 tausaga o suʻesuʻega fou i le fanua o meafaigaluega faafomaʻi e 2017, Med-link's tutoatasi atiaʻe suʻesuʻega vevela, toe faʻaaogaina le SpO₂ sensor, penitala ESU faʻaaogaina, pulupulu SpO₂ uaea faʻaopoopoga, eletise faiʻai e le osofaʻi, IBP cable etc, o nei faasologa uma o oloa ua faʻamaonia faʻamaonia e faʻalapotopotoga faʻavaomalo e pei ole CFDA, FDA, CE ma isi.

Faʻatasi ai ma le poto masani faʻataʻitaʻi i le maketi o meafaigaluega faʻafomaʻi, o le a tatou le faʻaogaina i le taimi ua tuanaʻi, ma o le a le naʻo le laʻasaga i lea laasaga. Fetuuna'i i suiga faifaipea maketi meafaigaluega faafomai, ausia manaoga aupito lata mai o vaega eseese, Med-link Medical o le a tulituliloa pea tulaga maualuga & tekinolosi maualuga, ma faamaonia lo tatou malosi i le lelei o oloa.

Fa'afeso'ota'i le tausiga o le olaga ma le fa'aeteete, fa'afaigofie le aufaigaluega fa'afoma'i, soifua maloloina tagata!