Cov cuab yeej siv kho mob xa mus rau cov twj, khoom siv, khoom siv, hauv cov tshuaj tiv thaiv kab mob hauv vitro thiab cov ntsuas, cov khoom siv thiab lwm yam khoom sib xws lossis cov khoom siv ncaj qha lossis ncaj qha rau tib neeg lub cev, suav nrog cov software uas yuav tsum muaj; Nws cov nqi hluav taws xob tau txais txiaj ntsig ntau dhau los ntawm kev siv lub cev, tsis yog los ntawm pharmacology, immunology lossis metabolism. Txawm hais tias muaj cov hau kev no koom nrog, tab sis tsuas yog ua lub luag haujlwm txhawb; nws lub hom phiaj yog:
(1) Kev kuaj mob, tiv thaiv, saib xyuas, kho lossis txo qis ntawm cov kab mob;
(2) Kev kuaj mob, tshuaj xyuas, kho mob, txo lossis nyiaj xaj kom raug mob ntawm kev raug mob;
(3) Kev tshuaj xyuas, hloov chaw, kho kom haum lossis pab txhawb nqa cov qauv txheej txheem lossis lub cev kev ua haujlwm;
(4) Lub neej txhawb nqa lossis saib xyuas;
(5) Kev tswj cev xeeb tub;
(6) Muab cov ntaub ntawv rau kev khomob lossis kev kuaj mob los ntawm kev kuaj cov kabmob ntawm tib neeg lub cev.
——" Kev Cai Tswj thiab Tswj Xyuas Khoom Siv Kho Mob" (Lub Xeev Pawg Sab Laj Qib No. 650, kho los ntawm Lub Xeev Pawg Sab Laj daim ntawv No. 680 hauv 2017)
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Raws li kuv lub teb chaws' s" Catalog ntawm Medical Devices Classification" tshaj tawm rau Lub Yim Hli 31, 2017 (Lub Xeev Lub Chaw Saib Xyuas Khoom Noj thiab Yeeb Tshuaj Tshaj Tawm No. 104 ntawm 2017), lub ntsej muag kev kho mob, lub qhov ncauj tiv thaiv kev kho mob, thiab lub ntsej muag kev kho mob siv hauv kev siv tshuaj yog txhua yam khoom siv kho mob thib ob. Tshooj 8 ntawm" Kev cai ntawm Kev Tswj Xyuas thiab Kev Tswj Xyuas Khoom Siv Kho Mob" sau tseg tias" Cov khoom kho mob hauv chav kawm I yuav tsum yog kev tswj hwm kev tso npe khoom, thiab Chav Kawm II thiab Chav III cov cuab yeej kho mob yuav tsum raug tswj hauv kev tswj hwm npe khoom." Tshooj 42 sau tseg tias" cov khoom kho mob txawv teb yuav yog cov cuab yeej siv kho mob uas tau sau npe lossis raug ua raws li cov tshooj cai 2 ntawm cov kev cai" tuaj yeem muab nyiaj tau.
Yog tias koj xav paub peb, thov hu rau: wym@eagleco.cn









