Qhov zoo ntawm cov khoom siv kho mob hauv tebchaws
Nyob rau hauv thiaj li yuav ntxiv dag zog rau qhov zoo saib xyuas thiab kev tswj ntawm khoom siv kho mobthiab xyuas kom meej
kev nyab xeeb thiab siv tau zoo ntawm cov khoom siv kho mob, Lub Xeev Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj tau ua tiav kev saib xyuas zoo thiab tshuaj xyuas ntawm 79 pawg ntawm rau ntau yam ntawm cov khaub ncaws phais,
Cov khoom siv ua haujlwm ntau zaus thiab tag nrho thyroxine nrhiav kom tau reagent. Tam sim no qhov sampling
cov txiaj ntsig yog raws li nram no:
Cov khoom piv txwv tsis ua raws li cov khoom siv kho mob tus qauv, suav nrog ob qho kev kho mob
cov khoom tsim khoom lag luam ntawm ob hom ntawm ob (Taiwan).
(A) phais khaub ncaws 1 lag luam 1 batch ntawm cov khoom. Jilin Fulang Medical Technology Co., Ltd.
ua ib pawg ntawm ib zaug siv cov khaub ncaws phais, impermeability (cov khoom tsis tseem ceeb hauv cheeb tsam)
tsis ua raws li tus qauv yuav tsum tau ua.
(2) high-frequency surgical khoom 1 enterprise 1 khoom. Guangdong Baisheng Medical Devices
Co., Ltd. tsim ib tug high-frequency hluav taws xob riam, lub enclosure ntawm lub kaw tsis tau raws li lub
tus qauv yuav tsum tau.
Cov qauv saum toj no tsis ua raws li cov kev cai tshwj xeeb ntawm cov khoom, saib Annex 1.
Yog sampling khoom rau kev txheeb xyuas cov ntawv, daim ntawv qhia thiab lwm yam khoom tsis ua raws li
cov qauv ntawm cov khoom siv kho mob, suav nrog ob lub chaw tsim khoom siv kho mob
ntawm ob hom ntawm ob.
(A) infusion twj / syringe twj tso kua mis 1 enterprise 1 khoom. Ib qho cim sab nraud ntawm lub twj tso kua mis infusion,
cov khoom siv lossis cov khoom siv ua los ntawm Changsha Yiyang Medical Instrument Co., Ltd. tsis
ua tau raws li tus qauv yuav tsum tau ua.
(2) high-frequency surgical khoom 1 enterprise 1 khoom. Guangdong Baisheng Medical Devices
Co., Ltd. tau tsim cov riam hluav taws xob ntau zaus, cov khoom siv lossis cov khoom siv ntawm sab nraud
cim tsis tau raws li tus qauv xav tau.
Cov qauv saum toj no tsis ua raws li cov kev cai tshwj xeeb ntawm cov khoom, saib Annex 2.
Thib peb, qhov kev ua piv txwv txhua tus ua tau raws li cov qauv kev kho mob cov khoom lag luam ntsig txog 43 kev kho mob
cov cuab yeej tsim khoom lag luam ntawm peb ntau yam ntawm 76 batch, saib Annex 3.
Plaub, qhov kev kuaj pom nyob rau hauv qhov tsis ua raws li cov kev cai ntawm cov khoom, Lub Xeev
Food and Drug Administration tau thov qhov chaw saib xyuas zaub mov thiab tshuaj thiab
kev tswj xyuas cov chaw ua haujlwm raws li "Kev Tswj Xyuas Kev Kho Mob thiab Tswj
Txoj Cai" thiab "Food and Drug Administration General Office ntawm kev ntxiv dag zog rau lub
Cov khoom siv kho mob Cov ntawv ceeb toom ua haujlwm "(Food and Drug Administration Supervision 〔2016〕 9),
cov tuam txhab muaj feem cuam tshuam los tshawb xyuas thiab daws nrog.
Cov khoom siv kho mob ntsig txog kev tsim khoom lag luam yuav tsum tsis ua raws li cov qauv kev cai
ntawm cov khoom, tsis ua raws li cov qauv ntawm qhov kev ntsuam xyuas kev pheej hmoo, raws li cov
qhov hnyav ntawm cov khoom siv kho mob los txiav txim siab txog qib ntawm kev rov qab los, pib pib rov qab
thiab cov ntaub ntawv rov qab rau pej xeem. Lub xeev cov zaub mov thiab tshuaj saib xyuas thiab tswj xyuas
departments nyob rau theem ntawm lub xeev yuav tsum saib xyuas cov xwm txheej rov qab los ntawm lub tuam txhab thiab
yuav rov qab los yog lawv tsis npaj qhov rov qab los. Yog tias pom cov khoom siv kho mob
kom tsis muaj teeb meem rau tib neeg lub cev lossis yog tias muaj pov thawj los ua pov thawj tias lawv tuaj yeem ua rau tib neeg
Kev noj qab haus huv, Kev ncua kev tsim khoom, kev tsim khoom, kev lag luam, kev siv cov kev tswj xyuas xwm txheej ceev. Muaj feem
Lub xeev cov zaub mov thiab tshuaj saib xyuas thiab kev tswj xyuas lub tuam tsev kom yaum cov lag luam los txheeb xyuas
qhov ua rau kom sai li sai tau, los tsim kho kev ntsuas thiab kho kom raug nyob rau hauv qhov chaw, lub
pov tseg qhov xwm txheej ntawm lub Plaub Hlis 24, 2017 rau pej xeem ua ntej tshaj tawm.
