Amanyathelo olawulo okubhaliswa kunye nokufayilishwa kwe-in vitro diagnostic reagents (emva koku kubhekiselwa kuzo "njengeMiqathango yoLawulo")

I-in vitro diagnostic reagent yobhaliso / i-arhente yokufayilisha
Uhlobo lokuqala lwe-in vitro diagnostic reagents luya kuxhomekeka kulawulo lwerekhodi yemveliso.Udidi II kunye neClass Ill in vitro diagnostic reagents ziya kuba phantsi kolawulo lobhaliso lwemveliso.
Ngenisa uhlobo lokuqala lwe-in vitro diagnostic reagents ukuze lufakwe, kwaye umfaki-fayile uya kungenisa izinto zokufayilisha kuLawulo lweeMveliso zoNyango lweSizwe.IKlasi yesi-II eThunyelwe ngaphandle kunye neKlasi ye-111 kwi-vitro diagnostic reagents iya kuvavanywa nguLawulo lweeMveliso zoNyango lweSizwe, kwaye emva kokuvunywa, isatifikethi sobhaliso lwesixhobo sonyango siya kukhutshwa.

Isebe lolawulo eliphakathi
ULawulo lweeMveliso zonyango lweSizwe lujongene nobhaliso kunye nolawulo lokufayilisha lwe-in vitro diagnostic reagents kwilizwe lonke, liququzelela uphononongo kunye nokwamkelwa kohlobo lwesibini nolwesithathu lwe-in vitro diagnostic reagents, kunye neerekhodi kunye nolawulo olunxulumeneyo kunye nolawulo lohlobo lokuqala lwe-in. i-vitro diagnostic reagents ngokomthetho;
Ulawulo lweeMveliso zonyango lweSizwe lweZiko loVavanyo lwezoNyango lwezoNyango lunoxanduva lovavanyo lobugcisa lwesicelo sobhaliso, utshintsho lobhaliso, uhlaziyo lobhaliso, njl.njl kwiKlasi yokugula e-China kunye neClass II kunye neClass Ill in vitro diagnostic reagents.

Udidi lolawulo "lweMiqathango yoLawulo"
Kwinkqubo yokuxela kwangaphambili isifo, ukuthintela, ukuxilongwa, ukubeka iliso kunyango, ukubonwa kwe-prognosis kunye novavanyo lwemeko yempilo, ii-reagents, iikiti, ii-calibrators, iimveliso zokulawula umgangatho kunye nezinye iimveliso ezisetyenziselwa ukufunyanwa kwe-in vitro yeesampuli zabantu zingasetyenziswa zodwa okanye ngokudityaniswa nezixhobo. , izixhobo zombane, izixhobo okanye iinkqubo.Ii-in vitro diagnostic reagents zokuhlolwa komthombo wegazi kunye ne-in vitro diagnostic reagents ezibhalwe ngeeradionuclides azikho ngaphakathi kwendawo yamanyathelo olawulo.


Ixesha lokuposa: Oct-22-2021