I-in vitro diagnostic reagent yokubhalisa/i-ejensi yokugcwalisa
Uhlobo lokuqala lwama-in vitro diagnostic reagents luzoba ngaphansi kokuphathwa kwerekhodi lomkhiqizo.I-Class II kanye ne-Class Ill in vitro diagnostic reagents izoba ngaphansi kokuphathwa kokubhaliswa komkhiqizo.
Ngenisa uhlobo lokuqala lwezindawo zokuxilonga ze-in vitro ukuze zifakwe, futhi umfaki wefayela uzohambisa izinto zokugcwalisa ku-National Medical Products Administration.Isigaba II esingenisiwe kanye ne-Class 111 in vitro diagnostic reagents zizohlolwa Ukuphathwa Kwemikhiqizo Yezokwelapha Kazwelonke, futhi ngemva kokugunyazwa, isitifiketi sokubhaliswa kwedivayisi yezokwelapha sizokhishwa.

Umnyango wokuphatha ophakathi nendawo
I-National Medical Products Administration iphethe ukubhaliswa nokuphathwa kwamafayela e-in vitro diagnostic reagents ezweni lonke, ihlela ukubuyekezwa nokugunyazwa kwezinhlobo zesibili nezesithathu ezingenisiwe zama-in vitro diagnostic reagents, namarekhodi kanye nokuqondisa okuhlobene nokuphathwa kohlobo lokuqala lwe-in. i-vitro diagnostic reagents ngokomthetho;
Isikhungo Sikazwelonke Sokuhlola Imikhiqizo Yezokwelapha Yesikhungo Sokuhlolwa Kwedivayisi Yezokwelapha sinesibopho sokuhlolwa kobuchwepheshe kwesicelo sokubhaliswa, ukushintsha ukubhaliswa, ukuvuselelwa kokubhaliswa, njll. Kwe-Class Ill e-China kanye nezisetshenziswa zokuxilonga ze-Class II kanye ne-Class Ill in vitro.

Isigaba sokuphatha "Sezinyathelo Zokuphatha"
Enqubweni yokubikezela isifo, ukuvimbela, ukuxilongwa, ukuqapha ukwelashwa, ukubhekwa kwesibikezelo kanye nokuhlolwa kwesimo sezempilo, ama-reagents, amakhithi, ama-calibrator, imikhiqizo yokulawula ikhwalithi kanye neminye imikhiqizo esetshenziselwa ukutholwa kwe-in vitro yamasampuli abantu ingasetshenziswa yodwa noma ihlanganiswe nezinsimbi. , izinto ezisetshenziswayo, okokusebenza noma amasistimu.Ama-in vitro diagnostic reagents okuhlolwa komthombo wegazi kanye nama-in vitro diagnostic reagents alebulwe ngama-radionuclides awekho ngaphakathi kwendawo yezinyathelo zokulawula.