FDA ndi United States Food and Drug Administration. Ndi limodzi mwa mabungwe akuluakulu okhazikitsidwa ndi boma la US mkati mwa Dipatimenti ya Zaumoyo wa Anthu (PHS) mkati mwa Dipatimenti ya Zaumoyo ndi Zaumoyo (DHHS). Udindo ndikuwonetsetsa chitetezo cha chakudya, zodzoladzola, mankhwala, biologics, zida zamankhwala, ndi zinthu zotulutsa ma radioactive zomwe zimapangidwa kapena kutumizidwa ku United States. FDA imagawidwa makamaka magawo awiri: kuyesa ndi kulembetsa. Zida zamankhwala, zodzoladzola, zakudya ndi mankhwala osokoneza bongo zimafunikira kulembetsa kwa FDA.
一 Ndi mitundu yanji yazinthu zomwe FDA imayang'anira?
Kuyang'anira ndi kuyang'anira chakudya, mankhwala (kuphatikizapo mankhwala a Chowona Zanyama), zipangizo zamankhwala, zowonjezera zakudya, zodzoladzola, zakudya zanyama ndi mankhwala osokoneza bongo, zakumwa za vinyo zomwe zili ndi mowa pansi pa 7%, ndi zinthu zamagetsi; ma ion ndi osapanga ma ion omwe amapangidwa pakugwiritsa ntchito kapena kugwiritsa ntchito zinthu Kuyesa, kuyang'anira ndi kutsimikizira zotsatira za radiation paumoyo wa anthu ndi chitetezo.
Chiphaso cha FDA chogulitsira kwaulere padziko lonse lapansi sizomwe zimangopereka ziphaso zapamwamba kwambiri ku US FDA certification, komanso chiphaso chodziwika bwino chazakudya ndi mankhwala chovomerezeka ndi World Trade Organisation (WTO). Ndilo lokhalo lomwe liyenera kuvomerezedwa mokwanira ndi US FDA ndi World Trade Organisation lisanaperekedwe. chiphaso cha certification. Chitsimikizochi chikapezeka, katunduyo akhoza kulowa m'dziko lililonse la membala wa WTO bwino, ndipo ngakhale chitsanzo cha malonda, boma la dziko limene liri sililoledwa kusokoneza.
二 Kodi pali kusiyana kotani pakati pa kuyesa kwa FDA, kulembetsa kwa FDA, ndi chiphaso cha FDA?
• Kuyesa kwa FDA
Nthawi zambiri, pazogulitsa zomwe zili m'magulu olamulidwa monga zida zolumikizirana ndi chakudya (monga makapu amadzi, mabotolo a ana, tableware, etc.), zodzoladzola, mankhwala, ndi zina zotero, lipoti la mayeso a FDA limafunikiranso kuwonetsa kuti malondawo akukwaniritsa zofunikira. Kuyesa kwa FDA ndikulembetsa kapena kulembetsa, ndipo palibe satifiketi yomwe imaperekedwa.
• Kulembetsa kwa FDA
Kulembetsa kwa FDA kumatengera mtundu wolengeza umphumphu, ndiko kuti, opanga ali ndi udindo pazogulitsa zawo zomwe zimakwaniritsa zofunikira ndi chitetezo, ndikulembetsa patsamba la federal la US. Ngati china chake sichikuyenda bwino ndi mankhwalawo, ayenera kukhala ndi maudindo ofanana. Chifukwa chake, pazinthu zambiri zolembetsedwa ndi FDA, palibe chifukwa chotumizira zitsanzo kuti ziyesedwe ndipo palibe ziphaso zomwe zimaperekedwa.
• Chitsimikizo cha FDA
Kunena zowona, palibe certification ya FDA. Awa ndi mwambi wamba. Ndilo dzina lophatikizana la kuyesa kwa FDA ndi kulembetsa kwa FDA, zonse zomwe zitha kutchedwa certification FDA.
三 Kodi Amazon ikufuna chiphaso cha FDA kapena kulembetsa kwa FDA?
Zimatsimikiziridwa makamaka potengera zinthu za wogulitsa. Mukalemba magulu azinthu monga zolumikizirana ndi chakudya (zophika, makapu amadzi, mabotolo a ana, ndi zina zotero), zodzoladzola, mankhwala, ndi zinthu zaumoyo patsamba la Amazon ku US, nthawi zambiri mumayenera kupereka lipoti loyesa la FDA. Ingopezani bungwe loyesa lachitatu lomwe limadziwika ndi Amazon kuti lipange malipoti oyenera.
Kwa makampani omwe amatumiza chakudya, mankhwala ndi zida zachipatala ku United States, ayenera kulembetsa ku FDA ndikulemba mndandanda wamakampani ndi zinthu, apo ayi miyambo siyichotsa katunduyo. Ndi chinthu chofunikira.
四 Kodi magulu omwe amapezeka papulatifomu ya Amazon ndi ati?
1.Food FDA kulembetsa
Mitundu yazinthu zomwe anthu amamwa ndi monga mowa, zopangira zokometsera, zakumwa, maswiti, chimanga, tchizi, chokoleti kapena koko, khofi kapena tiyi, mitundu yazakudya, zakudya zanthawi zonse kapena m'malo mwa chakudya kuphatikiza zakudya zopatsa thanzi, zakudya zogwira ntchito (kuphatikiza mankhwala azitsamba aku China) , zokometsera. , zinthu zam'madzi, zowonjezera zakudya, zotsekemera, zipatso ndi zinthu zawo, ma gels, ayisikilimu, zotsatsira mkaka, pasitala, nyama, mkaka, msuzi kapena kupanikizana, mtedza, mazira, masamba ndi zinthu zawo, mafuta a masamba, nyama yofananira, ufa kapena wowuma, ndi zina zotero. Zakudya za nyama zimaphatikizapo: chimanga, mbewu zamafuta, nyemba, amino acid, zinthu zanyama, zofukiza, zoteteza, zipatso za citrus, mankhwala osungunula, michere, mafuta, thovu, zinthu zam'madzi, mkaka, mchere, Molasses, sanali mapuloteni nayitrogeni mankhwala, chiponde zinthu, zonyansidwa ndi zinyalala zanyama, tchipisi toyesa, mavitamini, yisiti, chakudya cha ziweto, etc.
Makampani azakudyawa akuyenera kulembetsa ku US FDA kuti apeze nambala ya FFRN (Food Facility Registration Number) ndi PIN. Mukalembetsa kulembetsa, munthu yemwe amakhala ku United States ayenera kusankhidwa kukhala wothandizila waku US.
Nthawi yomweyo, zaka ziwiri zilizonse, nambala yolembetsa ya FDA yoyambirira imayenera kusinthidwa pakati pa 12:01 am pa Okutobala 1 ndi 11:59 pm pa Disembala 31 chaka chomwe chikutha mu nambala yofananira, apo ayi nambala yolembetsa yoyambirira idzakhala. zosavomerezeka.
Pazakudya zamzitini zokhala ndi asidi otsika komanso zokhala ndi asidi, kuphatikiza kulembetsa ndi FDA kuti apeze nambala ya FFRN ndi PIN, ayeneranso kulengeza njira yawo yopangira kuti apeze Chizindikiritso Chopereka (Nambala ya SID).
Pazakudya zathanzi, kuphatikiza kulembetsa ndi FDA kuti mupeze nambala ya FFRN ndi PIN, zinthu zathanzi zimafunikanso kunena zomwe zimagwira ntchito. Makampani ayenera kutumiza zonena zogwira ntchito ku FDA kuti ziwunikenso ndikusungitsa pasanathe masiku 30 malondawo atakhazikitsidwa.
Mafamu oikira mazira, molingana ndi zofunikira za lamulo la 21 CFR 118.1 (a), ali ndi nkhuku zoposa 3,000 ndipo samagulitsa mazira mwachindunji kwa ogula, ndipo ayenera kulembetsa ndi FDA ngati bizinesi. Mabizinesi amayenera kulembetsa kaye ndi Food Enterprise FDA molingana ndi zofunikira zamabizinesi wamba wamba, kuwonjezera pa nambala ya FFRN ndi PIN, kenako kulembetsa nambala ya famu ya mazira (Shell Egg Producer Registration).
Zakudya zikalembedwa pa nsanja ya Amazon, mudzafunsidwa kuti mupereke manambala olembetsa awa.
2.zodzikongoletsera
Malinga ndi malamulo a zodzoladzola a US FDA ndi zofunikira mwaufulu pakulembetsa zodzoladzola, makampani opanga zodzoladzola amatha kulembetsa zodzoladzola kudzera pakompyuta ya VCRP kapena kutumiza zikalata zamapepala mankhwalawo asanatulutsidwe kapena atatha ku United States. Pambuyo polembetsa, kampaniyo idzakhala ndi kalembera wa bizinesi (nambala yolembetsa), ndi nambala ya fomula yazinthu (CPIS). Zomwe kampani ikuyenera kupereka zikuphatikizanso zambiri za kampani (monga dzina, adilesi, munthu amene amayang'anira, zidziwitso zolumikizirana, ndi zina zotero), zambiri zamalonda (monga chizindikiro, fomula, nambala ya CAS, ndi zina zambiri).
Zodzoladzola zikayikidwa pa nsanja ya Amazon, mudzafunsidwa kuti mupereke manambala olembetsa awa.
3.zida zamankhwala
US FDA imagawa zida zamankhwala m'magulu atatu: Kalasi I, Kalasi II, ndi Gulu lachitatu malinga ndi kuchuluka kwa chiwopsezo.
Zogulitsa za Class l ndizinthu zomwe zili pachiwopsezo chochepa, ndipo zinthu zambiri za Class I ndizinthu zosatulutsidwa 510K. Malingana ngati makampani amalembetsa makampani awo ndi mindandanda yazogulitsa ndi FDA, ndikupeza nambala yolembetsa, zinthuzo zitha kuyikidwa pamsika.
Monga zida zambiri zopangira opaleshoni, stethoscopes, zida zamankhwala, mikanjo ya opaleshoni, zisoti za opaleshoni, masks, matumba otolera mkodzo, ndi zina zambiri.
Zogulitsa za Class II ndizomwe zimakhala pachiwopsezo chapakatikati. Zogulitsa zambiri za Class II zimayenera kufunsira FDA 510K kuti ziyikidwe pamsika. Mukapeza nambala ya 510K, kulembetsa mabizinesi ndi mndandanda wazogulitsa kumachitika. Pambuyo polandira nambala yolembetsa, akhoza kuikidwa pamsika (mawu omveka bwino mu mfundo 5 pansipa);
Monga ma thermometers, zowunikira kuthamanga kwa magazi, zothandizira kumva, zolumikizira mpweya, makondomu, singano za acupuncture, zida za electrocardiographic diagnostic, zida zosagwiritsa ntchito zowunikira, ma endoscopes owoneka, zida zodziwira akupanga, zowunikira zokha za biochemical, zoyezera kutentha kosalekeza, zida zonse zochizira mano. , thonje lamankhwala loyamwa, chopyapyala chamankhwala, etc.
Gulu la III lili ndi chiopsezo chachikulu kwambiri. Zogulitsa zambiri za Class III ziyenera kufunsira PMA zisanayikidwe pamsika. Mankhwalawa ayenera kuyesedwa kuchipatala. Pambuyo popeza nambala ya PMA, kampaniyo iyenera kulembetsedwa ndipo malondawo alembedwa. Mukapeza nambala yolembetsa, ikhoza kuyikidwa pamsika;
Monga ma pacemakers, extracorporeal shock wave lithotripsy, makina owunikira odwala, magalasi a intraocular, ma endoscopes, ma scalpels akupanga, zida zamtundu wa ultrasound, zida za opaleshoni ya laser, ma electrosurgery apamwamba kwambiri, zida zochizira ma microwave, zida zachipatala za MRI, Kugonana kwa kulowetsedwa. seti, zoikamo magazi, zida za CT, etc.
Zogulitsa zamankhwala zikalembedwa pa nsanja ya Amazon, adzafunika kupereka nambala yolembetsa.
4. Mankhwala osokoneza bongo
A FDA ali ndi ndondomeko yathunthu yotsimikizira za mankhwala opangira mankhwala kuti atsimikizire chitetezo ndi mphamvu ya mankhwala atsopano. Chofala kwambiri ndikuyang'ana kwambiri mankhwala a OTC ndikulembetsa NDC (Nambala Yotsimikizira Zamankhwala Yadziko Lonse).
5.Kodi a510 (k)? Kodi kuchita?
Ngati mankhwalawo atsimikiziridwa kuti ndi chipangizo chachipatala cha Class II, 510 (k) fayilo ikufunika.
Chikalata cha 510 (k) ndi chikalata chofunsira msika chisanachitike chomwe chatumizidwa ku FDA. Cholinga chake ndikutsimikizira kuti chipangizo chomwe chimagwiritsidwa ntchito potsatsa ndi chotetezeka komanso chogwira ntchito ngati chida chogulitsidwa mwalamulo chomwe sichimakhudzidwa ndi kuvomereza kusanachitike msika (PMA), ndiko kuti, ndi chipangizo chofanana (chofanana kwambiri). Wopemphayo afanizire chipangizo chomwe chimagwiritsidwa ntchito potsatsa ndi chimodzi kapena zingapo zofananira zomwe zili pamsika waku US, ndikujambula ndikutsimikizira kuti chipangizocho ndi chofanana.
五 Ndi chidziwitso chiti chomwe chimafunika kuti mulembetse fayilo ya 510 (k)?
01 Kalata yofunsira
Kuphatikizira zidziwitso zoyambira za wofunsayo (kapena munthu wolumikizana naye) ndi kampani, cholinga cha 510(K) kutumiza, dzina, chitsanzo ndi zidziwitso zamagawo a chipangizocho chomwe chagwiritsidwa ntchito pamndandanda, dzina lachidziwitso (Predicate Chipangizo) chambiri. kuyerekezera kofanana ndi Nambala yake 510(K);
02 Catalog
Ndiko kuti, mndandanda wazidziwitso zonse zomwe zili mufayilo ya 510 (k) (kuphatikiza zomata);
03 Chidziwitso Chotsimikizika Chowona
FDA ikhoza kupereka zitsanzo zokhazikika;
04 Dzina lazida
Ndiko kuti, dzina wamba mankhwala, FDA gulu gulu, ndi malonda malonda dzina;
05 Nambala yolembetsa
Ngati kampaniyo idalembetsa kampaniyo potumiza 510(K), chidziwitso cholembetsa chiyenera kuperekedwa. Ngati sichinalembetsedwe, chiyeneranso kudziwidwa;
06 Gulu
Ndiko kuti, gulu lamagulu, gulu, nambala ya kasamalidwe ndi kachidindo ka mankhwala;
07 Miyezo Yogwirira Ntchito
Miyezo yogwirira ntchito, yovomerezeka kapena yodzifunira yomwe chinthu chimakumana nacho;
08 Chidziwitso chazinthu
Kuphatikizira ma logo amakampani, malangizo ogwiritsira ntchito, zida zonyamula, zolemba zamakampani, ndi zina zambiri;
09 SE
kufananiza kwakukulu;
10 Mawu
510(k) Chidule kapena Chidule;
11 Kufotokozera Zamalonda
Kuphatikizira ntchito yomwe mukufuna kugwiritsa ntchito, mfundo yogwirira ntchito, gwero lamagetsi, zigawo, zithunzi, zojambula, zojambula zapamsonkhano, makonzedwe apangidwe, ndi zina zambiri;
12 Zotetezeka komanso zothandiza
Chitetezo ndi magwiridwe antchito azinthu, kuphatikiza mamangidwe osiyanasiyana ndi kuyesa deta;
13 mayesero wamba
Kugwirizana kwachilengedwe; magwiridwe antchito;
14 ikugwira ntchito
Zowonjezera zamtundu (ngati zilipo);
Kutsimikizira kwa mapulogalamu (ngati kuli kotheka);
15 Kutseketsa
Kutsekereza (ngati kuli kotheka), kuphatikiza kufotokoza kwa njira yoletsa kutsekereza, kutsimikizira kutsekereza kwazinthu ndi kulemba zilembo, ndi zina.
Zitha kuwoneka kuti njira yofunsira 510(k) ya zida zachipatala za Class II ndi yayitali kwambiri, ikutenga pafupifupi theka la chaka. Zogulitsa zomwe timalemba kuti FDA zilembetsedwe zili mu Gulu 1, Gulu 2 limafuna kulembetsa 510(k), ndipo Gawo 3 ndilovuta kwambiri.
六 Ndi mafunso ati omwe amafunsidwa kawirikawiri okhudza kulembetsa kwa FDA?
• Ndi bungwe liti lomwe limapereka satifiketi ya FDA?
Yankho: Kulembetsa kwa FDA kulibe satifiketi. Mankhwalawa adzalandira nambala yolembetsa polembetsa ndi FDA. A FDA adzapatsa wopemphayo kalata yoyankha (yosaina ndi wamkulu wa FDA), koma palibe satifiketi ya FDA.
• Kodi FDA imafuna kusankhidwacertified laboratory kuyezetsa?
Yankho: FDA ndi bungwe lazamalamulo, osati bungwe lothandizira. FDA ilibe mabungwe otsimikizira ntchito zoyang'ana pagulu kapena malo opangira ma laboratories, komanso ilibe "labotale yosankhidwa". Monga bungwe lazamalamulo la federal, a FDA sangathe kuchita nawo zinthu monga woweruza komanso wothamanga. FDA ingozindikira mtundu wa GMP wama labotale oyesa ntchito ndikupereka ziphaso zofananira ndi oyenerera, koma "sidzasankha" kapena kupangira labotale kapena ma laboratories kwa anthu.
• Kodi kulembetsa kwa FDA kumafuna wothandizila waku US?
Yankho: Inde, ofunsira ku China ayenera kusankha nzika yaku US (kampani / gulu) ngati wothandizira polembetsa ndi FDA. Wothandizirayo ali ndi udindo wochita ntchito ku United States ndipo ndiye mkhalapakati pakati pa FDA ndi wopemphayo.
• Kodi nambala yolembetsa ya FDA ndi yovomerezeka kwa nthawi yayitali bwanji?
Yankho: Palibe nthawi yovomerezeka ya malipoti a chakudya cha US. Chofunikira pakufunsiranso lipoti ndikuti katunduyo amayenera kutumizidwanso kuti akayesedwe ngati zinthu zomwe zasinthidwa kapena malamulo asinthidwa.
Nthawi yovomerezeka yakulembetsa kwa FDA pazida zamankhwala nthawi zambiri imakhala chaka chimodzi, pomwe Okutobala 1 chaka chilichonse amakhala malire. Ngati idzagwiritsidwa ntchito pasanafike pa 1 October, muyenera kulipira chindapusa chokonzanso pakati pa Okutobala ndi Disembala. Ngati itayikidwa pambuyo pa Okutobala 1st, iyenera kukonzedwanso ndi mwezi wotsatira. Ndalama zolembetsera ziyenera kulipidwa pakati pa Okutobala ndi Disembala pachaka kuti akonzenso. Ngati chindapusa sichilipidwa pofika tsiku lotha ntchito, kulembetsa kudzakhala kosavomerezeka.
• Zotsatira za kusakhala ndi nambala yolembetsa ya FDA ndi chiyani?
Yankho: Chotsatira chachikulu ndi chakuti ngati nsanja idziwa, idzaletsa mwachindunji chilolezo chake chogulitsa; chachiwiri, FDA nthawi zambiri imayang'ana zakudya, mankhwala, ndi zodzoladzola zomwe zimalowa ku United States (chiwerengero choyendera mwachisawawa ndi 3-5%). Ngati zitsanzo zowunikira mwachisawawa zili zoyenerera, gulu lazinthu zitha kutulutsidwa; ngati zitsanzo zowunikira mwachisawawa zili zosayenera, gululo "lidzamangidwa".
Ngati zovuta zomwe zapezeka pakuwunika ndizovuta (monga zizindikiro zosayenerera, ndi zina zotero), wobwereketsa akhoza kuloledwa kuzisamalira kwanuko ndikuzimasula pambuyo poyang'ananso; koma ngati mavuto omwe apezeka panthawi yowunika akugwirizana ndi thanzi labwino ndi chitetezo, ndiye kuti Palibe kumasulidwa kumaloledwa. Iyenera kuwonongedwa kwanuko kapena kubwezeredwa kudziko lotumiza kunja ndi wotumiza kunja, ndipo sangathe kusamutsidwa kumayiko ena. Kuphatikiza pakuwunika mwachisawawa, a FDA alinso ndi muyeso, kutanthauza kuti, zinthu zomwe zimatumizidwa kunja zomwe zili ndi zovuta zomwe zitha kuwonedwa zimayenera kuyesedwa batch ndi batch (m'malo moyang'ana mwachisawawa) polowa m'milandu, yomwe ndi muyeso wa "kutsekereza".
Nthawi yotumiza: Dec-22-2023