Yintoni isiqinisekiso se-FDA?

Yintoni isiqinisekiso se-FDA?

Yintoni isiqinisekiso se-FDA? Njengenkqubo yoqinisekiso lweUlawulo lokutya kunye neziyobisi lwase-US, isatifikethi se-FDA sidlala indima ebalulekileyo ekuphuhliseni amashishini kunye neemveliso. Isiqinisekiso se-FDA ayisiyiyo kuphela imeko eyimfuneko yokungena kwimarike yase-US, kodwa kunye nesiqinisekiso esibalulekileyo sokuqinisekisa ukhuseleko lwemveliso kunye nokhuseleko lwempilo yoluntu. Kweli phepha, siphonononga ingcamango, ukubaluleka kunye nefuthe kumashishini kunye neemveliso. FDA concept certification FDA, eyaziwa ngokuba"Isiqinisekiso soLawulo lokuTya kunye neDrug e-US", yi-arhente karhulumente wase-US enoxanduva lokuqinisekisa umgangatho, ukhuseleko kunye nokusebenza kakuhle kweemveliso ezifana nokutya, iziyobisi, izixhobo zonyango kunye nezithambiso. Isatifikethi se-FDA sisekelwe kumalungiselelo emithetho yomanyano lwase-US kunye nemimiselo eyilelwe ukukhusela impilo yoluntu kunye nokuqinisekisa ukuthotyelwa kunye nokhuseleko lweemveliso. Njengomnye wabalawuli abangqongqo kwihlabathi, i-FDA inokwamkelwa ngokubanzi kumazwe ngamazwe ngokutya kwayo kunye nezatifikethi zamachiza. Ngenjongo yokukhusela impilo yoluntu kunye nokuqinisekisa ukhuseleko lwemveliso, urhulumente wase-US useke izizathu zomthetho ezingqongqo kunye neenjongo zokuxhasa isiqinisekiso se-FDA. Isiseko esisemthethweni sesiqinisekiso se-FDA sibandakanya ikakhulu iUmthetho woKutya, iChiza kunye neZithambisokwayeiMedical Device Amendment Act. Ngesatifikethi se-FDA, urhulumente wase-US unokuphonononga, ukubeka iliso, kunye nokubeka iliso kwiimveliso ukuqinisekisa ukhuseleko, ukusebenza, kunye nokuthotyelwa kwazo ngexesha lokuthengisa kunye nokusetyenziswa. Ezo mfuno zingqongqo kunye neenkqubo zolawulo zibonelela ngokhuseleko kuluntu, kwaye zibonelela ngomda wokufikelela kwimakethi kunye nokuthembela kumashishini. Mbini.

Umda wokusetyenziswa kwesatifikethi se-FDA Uqinisekiso lwe-FDA lusebenza kuluhlu olubanzi lweendidi zemveliso, ingakumbi ezibandakanya, kodwa kungaphelelanga apho, ezi ndidi zilandelayo:

1.Ukutya: kubandakanywa izongezo zokutya, izinto zokupakisha ukutya, izongezo zokutya, njl.

2.Amachiza: ukuvala amayeza kagqirha, amayeza angabhalwanga, iimveliso zebhayoloji, njl.

3.Izixhobo zonyango: kubandakanywa izixhobo zonyango, ii-reagents zokuxilonga, izixhobo zotyando, izixhobo zokubeka iliso, njl.

4.Izithambiso: ezibandakanya iimveliso zokhathalelo lomntu, ifomula yokuthambisa kunye nokupakishwa, njl.

Ukushwankathela, isatifikethi se-FDA sibaluleke kakhulu kumashishini kunye neemveliso.Yimeko eyimfuneko yokungena kwimarike yaseMelika, kwaye inokuphucula ukukhuphisana kwemveliso kunye nentembeko yemarike. Ngesiqinisekiso se-FDA, iinkampani ziyakwazi ukubonisa iimveliso ezihlangabezana nemigangatho yesizwe kwaye zibonelele ngeemveliso ezithembekileyo nezikhuselekileyo. Ngelo xesha, isatifikethi se-FDA sikwanceda ukwakha nokukhusela ukuthembela kwabathengi kwiimveliso kunye nokuphucula ukukhuphisana kweshishini.