Ukuthengisa ukudla, izimonyo, izidakamizwa, neminye imikhiqizo e-Amazon US akudingi nje kuphela ukucatshangelwa kokupakishwa komkhiqizo, ezokuthutha, intengo, nokumaketha, kodwa futhi kudinga imvume evela ku-US Food and Drug Administration (FDA). Imikhiqizo ebhaliswe ne-FDA ingangena emakethe yase-US ukuze ithengiswe ukuze igweme ingcuphe yokukhishwa ohlwini.
Ukuthobelana nokuqinisekiswa kwekhwalithi kuyisihluthulelo sokuthunyelwa ngaphandle ngempumelelo, futhi ukuthola isitifiketi se-FDA "kuyipasipoti" yokungena emakethe yase-US. Ngakho-ke yini isitifiketi se-FDA? Yiziphi izinhlobo zemikhiqizo ezidinga ukubhaliswa ne-FDA?
I-FDA iyisikhungo esilawulayo sikahulumeni wobumbano wase-US onesibopho sokuqinisekisa ukuphepha, ukusebenza kahle, nokuhambisana nokudla, izidakamizwa, izisetshenziswa zezokwelapha, neminye imikhiqizo ehlobene. Lesi sihloko sizokwethula ukubaluleka kwesitifiketi se-FDA, ukuhlukaniswa kwezitifiketi, inqubo yokuqinisekisa, kanye nezinto ezidingekayo zokufaka isicelo sokuthola isitifiketi. Ngokuthola isitifiketi se-FDA, izinkampani zingadlulisa ukuzethemba kwekhwalithi nokuphepha komkhiqizo kubathengi futhi zandise imakethe yazo.
Ukubaluleka Kwesitifiketi Se-FDA
Ukuqinisekiswa kwe-FDA kungenye yezinto ezibalulekile ezinkampanini eziningi ukuze zithole impumelelo emakethe yase-US. Ukuthola isitifiketi se-FDA kusho ukuthi umkhiqizo uhlangabezana nezindinganiso eziqinile nezimfuneko ze-FDA, ngekhwalithi ephezulu, ukuphepha, nokuhambisana. Kubathengi, isitifiketi se-FDA siyisiqinisekiso esibalulekile sekhwalithi nokuphepha komkhiqizo, okubasiza ukuthi benze izinqumo zokuthenga benolwazi. Kumabhizinisi, ukuthola isitifiketi se-FDA kungathuthukisa isithunzi somkhiqizo, kukhuphule ukwethenjwa kwabathengi, futhi kusize imikhiqizo igqame emakethe eqhudelana kakhulu.
Ukuhlolwa kwe-FDA
2. Ukuhlelwa kwesitifiketi se-FDA
Isitifiketi se-FDA sihlanganisa izigaba eziningi zemikhiqizo, ikakhulukazi okuhlanganisa ukudla, imithi, izinto zezokwelapha, i-biologics, nemikhiqizo yemisebe. I-FDA isungule izindinganiso ezihambisanayo zesitifiketi nezinqubo zezigaba zemikhiqizo ehlukene. Ukuqinisekiswa kokudla kubandakanya ukubhaliswa kwamabhizinisi okukhiqiza ukudla, ukugunyazwa kwezithasiselo zokudla, nokuthobela amalebula okudla. Ukuqinisekiswa kwezidakamizwa kuhlanganisa izivivinyo zomtholampilo kanye nokugunyazwa kwemithi emisha, isitifiketi sokulingana kwemithi ejwayelekile, kanye nokukhiqizwa nokudayiswa kwezidakamizwa. Isitifiketi sedivayisi yezokwelapha sihlanganisa ukuhlukaniswa kwemishini yezokwelapha, 510 (k) isaziso sangaphambi kwemakethe, kanye nesicelo se-PMA (sokugunyazwa kwangaphambili). Ukuqinisekiswa komkhiqizo webhayoloji kuhlanganisa ukugunyazwa nokubhaliswa kwemithi yokugoma, imikhiqizo yegazi, kanye nemikhiqizo yokwelapha ngofuzo. Isitifiketi somkhiqizo we-radiation sifaka isitifiketi sokuphepha semishini yezokwelapha, i-radiopharmaceuticals yezokwelapha, kanye nemikhiqizo kagesi.
3. Yimiphi imikhiqizo edinga isitifiketi se-FDA?
3.1 Ukuhlolwa kwe-FDA kanye nesitifiketi sezinto zokupakisha ukudla
3.2 Ukuhlolwa kwe-FDA kanye nesitifiketi semikhiqizo ye-ceramic yengilazi
3.3 Ukuhlolwa kwe-FDA kanye nesitifiketi semikhiqizo yepulasitiki yebanga lokudla
3.4 Ukudla: okuhlanganisa ukudla okugayiwe, ukudla okupakishiwe, ukudla okuqandisiwe, njll
3.5 Amadivayisi Ezokwelapha: Imaski kanye Nezisetshenziswa Zokuzivikela, njll
3.6 Imithi: Imithi kadokotela kanye nemithi ethengwayo, njll
3.7 Izithako zokudla, izithasiselo zokudla, njll
3.8 Iziphuzo
3.9 Izinsiza ezihlobene nokudla
3.10 Ukuhlolwa kwe-FDA kanye nesitifiketi semikhiqizo yokumboza
3.11 Ukuhlolwa Nokugunyazwa Kwemikhiqizo Yezingxenyekazi Zekhompyutha ye-FDA
3.12 Ukuhlolwa kwe-FDA kanye nesitifiketi semikhiqizo ye-rubber resin
3.13 Ukuhlolwa Kwezinto Ezisetshenziswayo ze-FDA kanye Nesitifiketi
3.14 Ukuhlolwa kwe-FDA kanye nezitifiketi zezithasiselo zamakhemikhali
3.15 Imikhiqizo Ye-Laser Radiation
3.16 Izimonyo: Izithasiselo zombala, izinto zokuthambisa isikhumba, nezinto zokuhlanza, njll.
3.17 Imikhiqizo yezilwane: izidakamizwa zezilwane, ukudla kwezilwane ezifuywayo, njll
3.18 Imikhiqizo kagwayi
Ilebhu yokuhlola ye-BTF, inkampani yethu inamalabhorethri ahambisana nogesi, izimiso zokuphepha Ilabhorethri, Ilabhorethri yefrikhwensi yomsakazo, Ilabhorethri yebhethri, Ilabhorethri yamakhemikhali, I-SAR Laboratory, I-HAC Laboratory, njll. Sithole iziqu nokugunyazwa okufana ne-CMA, CNAS, CPSC, A2LA, I-VCCI, njll. Inkampani yethu inethimba lobunjiniyela bezobuchwepheshe abanolwazi nochwepheshe, elingasiza amabhizinisi ukuxazulula inkinga. Uma unezidingo ezifanele zokuhlola nezitifiketi, ungathintana ngqo nabasebenzi bethu bokuhlola ukuze uthole amakhotheshini anemininingwane yezindleko kanye nolwazi lomjikelezo!
Ukubhaliswa kwe-FDA yezokwelapha
Isikhathi sokuthumela: Aug-14-2024
