I-FDA ikhiphe isaziso esinesihloko esithi "Ukubhaliswa Kwedivayisi nohlu" kuwebhusayithi yayo esemthethweni ngomhla zingama-23 Juni, okugcizelele ukuthi:
I-FDA ayikhiphi izitifiketi zokubhalisa kwizikhungo zedivayisi yezokwelapha. I-FDA ayiqinisekisi ukubhaliswa nohlu
Imininingwane yamafemu abhalisile futhi abhalwe phansi. Ukubhalisa nohlu akusho ukuvunyelwa noma imvume yefemu
noma amadivayisi abo.
Izingqinamba esidinga ukunaka ukubhaliswa ekubhalisweni kwe-FDA zimi ngokulandelayo:
Umbuzo 1: Yikuphi i-ejensi ekhishwe isitifiketi se-FDA?
A: Asikho isitifiketi sokubhaliswa kwe-FDA. Uma umkhiqizo ubhaliswe nge-FDA, kuzotholakala inombolo yokubhalisa. I-FDA izonikeza umenzi wesicelo incwadi impendulo (esayinwe yisikhulu esiphezulu se-FDA), kepha asikho isitifiketi se-FDA.
Ukumenyezelwa kukaFda kwalesi saziso ngalesi sikhathi kuyisikhumbuzo esiqinile! Ngenxa yokuthuthukiswa kwakamuva kwesimo se-ebhubhane e-United States, isidingo semikhiqizo yokuvimbela ubhubhane lwezokwelapha ethunyelwa e-United States sikhuphuke kakhulu, futhi isidingo sokubhaliswa kwamanye amazwe siye sanda
Lapho amanye amabhizinisi elingisa izitifiketi kubakhiqizi, amanye amabhizinisi okushicilela angathola izitifiketi ezingamanga "ze-FDA lapho bebonisana nabakhiqizi.
Umbuzo 2: Ngabe i-FDA idinga ilabhorethri eqinisekisiwe?
A: I-FDA yi-ejensi yokuqinisa umthetho, hhayi inhlangano yenkonzo. Uma umuntu ethi i-FDA Certification Labhorator, okungenani bangabathengi abadukisayo, ngoba i-FDA ayinazo izisebenzi zomphakathi
Ama-ejensi wokuqinisekiswa kwezocansi kanye nama-laboratories, alikho elenzelwe lealabhoratri ebizwa ngokuthi ". Njengomthetho we-Federal Law Enformement ejensi, i-FDA akufanele ibambe iqhaza ezintweni ezinjengokuthi yomabili onolwazi nomsubathi. I-FDA izovivinya kuphela inkonzo
Ikhwalithi ye-GMP yelebhu izobonwa, futhi ofanelekayo uzonikezwa isitifiketi, kepha ngeke "aqokwe" noma anconywe emphakathini.
Umbuzo 3: Ngabe ukubhaliswa kwe-FDA kudinga i-ejenti yaseMelika?
A: Yebo, ibhizinisi kufanele liqoke isakhamuzi saseMelika (inkampani / inhlangano) njenge-ejenti yayo lapho ibhalisela ne-FDA. Umenzeli ubhekele izinsizakalo zenqubo ezitholakala e-United States, okuyizindaba zokuxhumana ne-FDA kanye nomenzi wesicelo.
Amaphutha ajwayelekile ukubhaliswa kwe-FDA
1. Ukubhaliswa kwe-FDA kuhlukile kwesitifiketi se-CE. Imodi yayo yesitifiketi ihlukile ku-CE CEETICTION PROCTIFACTION PROCTION TEATICT + Imodi yokubika isitifiketi. Ukubhaliswa kwe-FDA empeleni kwamukele imodi yokumemezela yobuqotho, okungukuthi, unemodi enhle yokumemezela ukholo kwimikhiqizo yakho
Ngokuhambisana namazinga nezidingo zokuphepha ezifanele, futhi ebhaliswe kuwebhusayithi ye-US Federal, uma kunengozi ngomkhiqizo, khona-ke kufanele sithwale umthwalo ohambisanayo. Ngakho-ke, ukubhaliswa kwe-FDA emikhiqizweni eminingi, akukho okuthunyelwe kwesampula
Kanye nesitatimende sesitifiketi.
2. Isikhathi sokuvunyelwa sokubhaliswa kwe-FDA: Ukubhaliswa kwe-FDA kusebenza unyaka owodwa. Uma kungaphezu konyaka owodwa, kudinga ukuhanjiswa kabusha ukuze kubhaliswe, futhi imali yonyaka ebandakanyekayo nayo idinga ukukhokhwa futhi.
3. Ingabe i-FDA ibhalisiwe isitifiketi?
Eqinisweni, asikho isitifiketi sokubhaliswa kwe-FDA. Uma umkhiqizo ubhaliswe nge-FDA, kuzotholakala inombolo yokubhalisa. I-FDA izonikeza umenzi wesicelo incwadi impendulo (esayinwe yisikhulu esiphezulu se-FDA), kepha asikho isitifiketi se-FDA.
Isitifiketi esivame ukubona ukuthi sikhishwe yi-Agency Agency (Umenzeli wokubhalisa) kumenzi ukufakazela ukuthi usize umenzi ukuthi aqedele "ukubhaliswa kohlobo lomkhiqizo" okudingeka nge-FDA
(Ukusungulwa kokusungulwa kanye nohlu lwedivayisi), uphawu oluqediwe ukusiza abakhiqizi bathole inombolo yokubhaliswa kwe-FDA.
Ngokwamazinga ehlukene wobungozi, i-FDA ihlukanisa amadivaysi ezokwelapha ngezigaba ezintathu (i, ii, iii), kanye ne-Class III inezinga eliphakeme kakhulu lengozi.
I-FDA ichaze ngokucacile ukuhlukaniswa komkhiqizo kanye nezidingo zokuphatha idivaysi ngayinye yezokwelapha. Njengamanje, kunezinhlobo ezingaphezu kuka-1700 zekhathalogi yedivayisi yezokwelapha. Uma noma iyiphi idivaysi yezokwelapha ifuna ukungena emakethe yase-US, kufanele iqale ukucacisa ukuhlukaniswa kanye nezidingo zokuphatha zemikhiqizo esetshenziselwa ukumaketha.
Ngemuva kokucacisa imininingwane engenhla, ibhizinisi lingaqala ukulungiselela izinto ezifanele zohlelo lokusebenza, futhi libike kwi-FDA ngokwezinqubo ezithile zokuthola imvume. Kunoma yimuphi umkhiqizo, amabhizinisi adinga ukubhalisa nohlu lwemikhiqizo.
Emikhiqizweni yeklasi i-Class I imikhiqizo (accounting cishe 47%), kusetshenziswa amandla ajwayelekile. Iningi lemikhiqizo lidinga ukubhaliswa kuphela, okusohlwini futhi kusetshenziswe amazinga we-GMP, futhi imikhiqizo ingangena emakethe yase-US (bambalwa kakhulu abaxhumeke nge-GMP)
Inani elincane kakhulu lemikhiqizo egciniwe lidinga ukuhambisa uhlelo lwe-510 (k) ku-FDA, okungukuthi i-PMN (Isaziso se-Premarket));
Ngemikhiqizo yeklasi II (accounting cishe 46%), kusetshenziswa okukhethekile kokulawulwa. Ngemuva kokubhalisa nohlu, amabhizinisi adinga ukusebenzisa i-GMP futhi athumele uhlelo lokusebenza lwe-510 (k) (imikhiqizo embalwa (k));
Ngemikhiqizo yeklasi iii (cishe ngo-7%), kusetshenziswa ilayisense yangaphambi kokuthengisa. Ngemuva kokubhalisa nohlu, amabhizinisi kumele asebenzise i-GMP futhi ahambise uhlelo lokusebenza lwe-PMA (Premarket application) ku-FDA (Ingxenye III)
Pmn).
Emikhiqizweni yeklasi ikilasi, ngemuva kokuthi ibhizinisi lihambisa imininingwane efanelekile ku-FDA, i-FDA kuphela yenza isimemezelo, futhi akukho sitifiketi esifanelekile esinikezwa ibhizinisi; kumadivayisi we-Class II ne-III, ibhizinisi kumele lilethe i-PMN noma i-PMA, ne-FDA
Nikeza i-Enterprise Incwadi Yokuvunyelwa Ukufinyelela Kwemakethe okusemthethweni, okungukuthi, vumela amabhizinisi ukuthi athengise ngqo imikhiqizo yawo eMakethe yedivayisi yezokwelapha yase-US ngegama layo.
Ukuthi uya ebhizinisini lokuhlola i-GMP kwinqubo yohlelo lokusebenza unqunywe yi-FDA ngokuya ngezinga lobungozi bomkhiqizo, izidingo zokuphatha kanye nempendulo yemakethe nezinye izinto eziphelele.
Ukusuka okungenhla, siyabona ukuthi iningi lemikhiqizo lingathola isitifiketi se-FDA ngemuva kokubhalisa, uhlu lomkhiqizo kanye nokuqaliswa kwe-GMP yamadivayisi wezokwelapha, noma ukulethwa kwesicelo se-510 (k).
Ungahlola kanjani ukuthi ngabe umkhiqizo ufakwe kuhlu lwe-FDA noma ubhalisiwe ngo-510k?
Indlela kuphela egunyaziwe: Bheka kuwebhusayithi ye-FDA
Isikhathi sePosi: Jan-09-2021