June 21, 2017, China FDA yakazivisa 14thchiziviso chemhando yemidziyo yekurapa uye yakaburitswa yemhando yepamusoro & sampuli yekuongorora mamiriro ezvikamu zvitatu 247 seti zvigadzirwa zvakaita sekuraswa tracheal machubhu, zvekurapa zvemagetsi thermometer nezvimwe.
Random-yakaongororwa samples isingaenderane nezviyero zvemidziyo yekurapa inosanganisira 3 mapoka 4 seti zvigadzirwa zvinogadzirwa nevagadziri vemidziyo yekurapa 4; zvinhu zvakaongororwa senge mazita ekuzivikanwa, mabhurocha nezvimwe zvisingaenderane nezviyero ndeye 1 chikamu 2 seti michina yekurapa inogadzirwa ne2 vagadziri vemidziyo yekurapa; 3 mapoka 241 seti yezvokurapa inogadzirwa ne92 vagadziri vezvishandiso zvekurapa zvinosangana nemazinga akakodzera ezvese zvinhu zvakaongororwa.
Parizvino, National Food and Drug Administration yakatokumbira madhipatimendi anoona nezvechikafu nezvinodhaka uye manejimendi kuti aferefete uye aite nemabhizinesi akakodzera, uye akakumbira madhipatimendi anoona nezvechikafu nezvinodhaka uye madhipatimendi ekutonga kuti azivise kuraswa kwemamiriro ezvinhu kune veruzhinji. .
Kuti tisimbise kutariswa kwemhando uye manejimendi emidziyo yekurapa uye kuve nechokwadi chekushandiswa kwakachengeteka uye kunobudirira kwemidziyo yekurapa, FDA yedu yenyika nguva pfupi yadarika inoita utariri hwemhando yepamusoro uye sampling zvinoenderana nekuwanda kweavhareji kaviri pamwedzi. Iyo inomiririra zvizere kunetseka kwehurumende nezvemidziyo yekurapa, inodiwa kumira bvunzo yemusika kana iwe uchida kuenda mumugwagwa uyu kure.
Shenzhen Med-link Medical Electronics Co., Ltd. inogara ichida kuti zvigadzirwa zvese zvisangane neyazvino nyika uye yepasirese mwero. Sezvo yakavambwa muna 2004, mushure mekuronga kwegore, Med-link yekutanga batch yeECG tambo uye waya yekutungamirira yakapfuura CFDA kunyoresa zvinobudirira, kutanga kwakanaka uye zvakare humbowo hwakanakisa hwekuedza kwedu.
Mushure memakore gumi nematatu ekutsvaga kwetsvakiridzo mumunda wemidziyo yekurapa ne2017, Med-link's yakazvimiririra yakagadziridzwa tembiricha probe, reusable SpO₂ sensor, inoraswa ESU penzura, pulse SpO₂ yekuwedzera tambo, isiri-invasive brain electrode, IBP tambo nezvimwe, ese aya akateedzana zvigadzirwa zvakasimbiswa nemvumo nemasangano epasi rese akadai seCFDA, FDA, CE nezvimwe.
Tine ruzivo rwakaedzwa kwenguva refu mumusika wemidziyo yekurapa, isu hatisi kuzopinda munguva yakapfuura, uye zvakare hatizongoita nhanho nhanho. Kuchinjira kumusika wemidziyo yekurapa unogara uchichinja, kusangana nezvido zvitsva zvemapoka akasiyana, Med-link Medical inogara ichitsvaga yakakwira mwero & yepamusoro tekinoroji, uye kuratidza simba redu nemhando yechigadzirwa.
Kubatanidza kuchengetedza kwehupenyu nekutarisira, ita kuti vashandi vekurapa vave nyore, vanhu vane hutano!
Nguva yekutumira: Aug-28-2017