Nyob rau hauv vitro diagnostic reagent sau npe / ua ntaub ntawv lub koom haum
Thawj hom hauv vitro diagnostic reagents yuav tsum raug tswj xyuas cov ntaub ntawv cov khoom.Class II thiab Class Ill in vitro diagnostic reagents yuav tsum raug tswj xyuas cov khoom lag luam.
Ntshuam thawj hom hauv vitro diagnostic reagents rau kev ua ntaub ntawv, thiab cov ntaub ntawv yuav tsum xa cov ntaub ntawv mus rau National Medical Products Administration.Imported Class II thiab Class 111 in vitro diagnostic reagents yuav tsum raug tshuaj xyuas los ntawm National Medical Products Administration, thiab tom qab kev pom zoo, yuav tsum tau muab daim ntawv pov thawj sau npe kho mob.

Centralized tswj department
National Medical Products Administration yog tus saib xyuas ntawm kev sau npe thiab kev tswj xyuas ntawm in vitro diagnostic reagents thoob teb chaws, teeb tsa kev tshuaj xyuas thiab kev pom zoo ntawm cov khoom siv thib ob thiab thib peb ntawm cov tshuaj tiv thaiv vitro diagnostic reagents, thiab cov ntaub ntawv thiab cov ntaub ntawv ntsig txog kev saib xyuas thiab kev tswj hwm ntawm cov khoom lag luam thawj zaug hauv vitro. vitro diagnostic reagents raws li txoj cai;
National Medical Products Administration Medical Device Technical Evaluation Center yog lub luag haujlwm rau kev soj ntsuam kev soj ntsuam ntawm daim ntawv thov kev sau npe, kev hloov pauv ntawm kev sau npe, rov ua dua tshiab, thiab lwm yam ntawm Class Ill nyob rau hauv Suav teb thiab imported Class II thiab Class Ill in vitro diagnostic reagents.

Pawg tswj hwm ntawm "Kev Tswj Xyuas Kev Tswj Xyuas"
Nyob rau hauv cov txheej txheem ntawm kev kwv yees kab mob, kev tiv thaiv, kev kuaj mob, kev saib xyuas kev kho mob, kev soj ntsuam kev soj ntsuam thiab kev soj ntsuam kev noj qab haus huv, reagents, khoom siv, calibrators, tswj cov khoom zoo thiab lwm yam khoom siv rau hauv vitro nrhiav pom tib neeg cov qauv siv tau ib leeg lossis ua ke nrog cov cuab yeej. , khoom siv, khoom siv lossis tshuab.Hauv vitro diagnostic reagents rau kev kuaj ntshav thiab hauv vitro diagnostic reagents sau npe nrog radionuclides tsis nyob rau hauv qhov kev tswj hwm kev ntsuas.