FDA ndiyo United States Food and Drug Administration. Ndiyo imwe yemasangano makuru akagadzwa nehurumende yeUS mukati meDhipatimendi rePublic Health (PHS) mukati meDhipatimendi reHutano neHuman Services (DHHS). Basa nderekuona kuchengetedzwa kwechikafu, zvekuzora, zvinodhaka, biologics, midziyo yekurapa, uye zvigadzirwa zveradioactive zvinogadzirwa kana kutumirwa kuUnited States. FDA inonyanya kukamurwa kuita zvikamu zviviri: kuyedza uye kunyoresa. Zvishandiso zvekurapa, zvekuzora, chikafu uye zvigadzirwa zvezvinodhaka zvinoda kunyoreswa kweFDA.
一 Mhando dzezvigadzirwa zvinotarisirwa neFDA?
Kutarisa uye kuongororwa kwezvokudya, zvinodhaka (kusanganisira veterinary drugs), zvigadzirwa zvemishonga, zvinowedzera zvekudya, zvipfeko, zvokudya zvemhuka nemishonga, zvinwiwa zvewaini zvine doro pasi pe7%, uye zvigadzirwa zvemagetsi; ions uye asiri-ion anogadzirwa panguva yekushandiswa kana kushandiswa kwezvigadzirwa Kuedza, kuongorora uye kupihwa chitupa chemwaranzi mhedzisiro pahutano hwevanhu nekuchengetedzeka.
Iyo FDA yepasirese yemahara rezinesi rezenisi haisi iyo yepamusoro nhanho yechitupa muUS FDA certification, asiwo yakajairika chitupa chechikafu nemishonga inotenderwa neWorld Trade Organisation (WTO). Ndiyo yega inofanirwa kubvumidzwa zvizere neUS FDA neWorld Trade Organisation isati yapihwa. chitupa chitupa. Kana chitupa ichi chawanikwa, chigadzirwa chinogona kupinda chero nyika yenhengo yeWTO mushe, uye kunyangwe mhando yekushambadzira, hurumende yenyika iyo iripo haibvumidzwe kupindira.
二 Ndeupi musiyano uripo pakati pekuyedzwa kweFDA, kunyoreswa kweFDA, uye FDA certification?
• Kuongororwa kweFDA
Kazhinji, kune zvigadzirwa zviri pasi pezvikamu zvakadzorwa senge chikafu chekubata (senge makapu emvura, mabhodhoro evana, tableware, nezvimwewo), zvekuzora, mishonga, nezvimwewo, FDA test report inodiwawo kuratidza kuti chigadzirwa chinosangana nemhando zvinodiwa. FDA kuyedzwa kunyoresa kana kunyoreswa, uye hapana chitupa chinopihwa.
• FDA kunyoresa
Kunyoreswa kweFDA kunotora modhi yekuzivisa yekuvimbika, kureva kuti, vagadziri vane basa rekuti zvigadzirwa zvavo zvikwane zvinoenderana nemitemo uye kuchengetedza zvinodiwa, uye kunyoresa pawebhusaiti yemubatanidzwa weUS. Kana chimwe chinhu chisina kunaka pachigadzirwa, vanofanirwa kutakura mabasa anoenderana. Naizvozvo, kune zvakawanda zvigadzirwa zvakanyoreswa neFDA, hapana chikonzero chekutumira masampula ekuongororwa uye hapana zvitupa zvinopihwa.
• FDA certification
Kunyatsotaura, hapana FDA certification. Ichi chirevo chinozivikanwa. Iri chaizvo zita remubatanidzwa rekuyedza FDA uye kunyoreswa kweFDA, ese ari maviri anogona kunzi FDA certification.
三 Ko Amazon inoda FDA certification kana FDA kunyoreswa?
Zvinonyanya kutsanangurwa zvichibva pane zvigadzirwa zvemutengesi. Kana uchinyora zvikamu zvezvigadzirwa zvakadai sezvekudya zvekushandisa (kitchenware, makapu emvura, mabhodhoro evana, nezvimwewo), zvekuzora, mishonga, uye zvigadzirwa zvehutano panzvimbo yeAmazon US, iwe kazhinji unofanirwa kupa FDA test report. Ingotsvaga yechitatu-bato rekuyedza agency inozivikanwa neAmazon kuita mishumo yakakodzera.
Kune makambani anoendesa kunze chikafu, zvinodhaka nemidziyo yekurapa kuUnited States, vanofanirwa kunyoresa neFDA uye kunyora kambani uye zvigadzirwa, zvikasadaro tsika hadzizobvisa zvinhu. Icho chinhu chinosungirwa.
四 Ndeapi akajairwa zvigadzirwa zvikamu paAmazon platform?
1.Food FDA kunyoresa
Mhando dzezvigadzirwa zvinonwiwa nevanhu zvinosanganisira doro, zvigadzirwa zvemaconfectionery, zvinwiwa, zvihwitsi, zviyo, chizi, chokoreti kana cocoa, kofi kana tii, mavara echikafu, chikafu chenguva dzose kana kudya kunotsiva kunosanganisira chikafu chakapindwa, chikafu chinoshanda (kusanganisira Chinese mishonga yemakwenzi) , condiments. , zvigadzirwa zvemumvura, zvinowedzerwa zvekudya, zvinotapira, michero uye zvigadzirwa zvavo, gels, ice cream, yekutevedzera yemukaka zvigadzirwa, pasta, nyama, mukaka, muto kana jamu, nzungu, mazai, miriwo uye zvigadzirwa, mafuta emuriwo, inofananidzwa nyama, hupfu kana starch, etc. Zvokudya zvemhuka zvinosanganisira: zviyo, mhodzi dzemafuta, alfalfa, amino acids, zvigadzirwa zvemhuka, zvigadzirwa zvakabikwa, zvinochengetedza, zvigadzirwa zvecitrus, zvigadzirwa zvakanyungudutswa, maenzayimu, mafuta, zvigadzirwa zvakaviriswa, zvigadzirwa zvemumvura, zvigadzirwa zvemukaka, zvicherwa, Molasses, zvisiri -protein nitrogen zvigadzirwa, zvigadzirwa zvenzungu, tsvina yemhuka yakadzokororwa zvigadzirwa, kuongorora machipisi, mavhitaminzi, mbiriso, chikafu chemhuka, nezvimwe.
Aya makambani echikafu anofanirwa kuendesa kunyoreswa kuUS FDA kuti atore nhamba yeFFRN (Food Facility Registration Number) nePIN. Kana uchinyorera kunyoreswa, munhu anogara muUnited States anofanira kusarudzwa semumiriri weUS.
Panguva imwecheteyo, makore maviri ega ega, iyo yekutanga FDA nhamba yekunyoresa inoda kuvandudzwa pakati pe12:01 am muna Gumiguru 1 na11:59 pm musi waZvita 31 wegore rinopera mune imwe nhamba, zvikasadaro nhamba yekutanga yekunyoresa ichave. invalid.
Zvekudya zvakaderera-asidhi zvemumagaba uye zvine acidified, pamusoro pekunyoresa neFDA kuti vawane nhamba yeFFRN nePIN, vanofanirwawo kuzivisa maitiro avo ekugadzirisa kuti vawane Submission Identifier (Nhamba yeSID).
Zvekudya zvehutano, pamusoro pekunyoresa neFDA kuti uwane iyo FFRN nhamba nePIN, zvigadzirwa zvehutano zvinodawo kuita zvichemo zvinoshanda. Makambani anofanirwa kuendesa zvichemo zvinoshanda kuFDA kuti iongororwe uye inyore mukati memazuva makumi matatu chigadzirwa chatangwa.
Mapurazi anokandira mazai, zvinoenderana nezvinodiwa nemutemo 21 CFR 118.1 (a), ane huku dzinopfuura zviuru zvitatu uye haatengese mazai zvakananga kune vatengi, uye anofanirwa kunyoresa neFDA sebhizinesi. Mabhizinesi anofanirwa kutanga anyoresa neFood Enterprise FDA zvinoenderana nezvinodiwa nemabhizinesi akajairwa echikafu, kuwedzera kune nhamba yeFFRN nePIN, uyezve kunyoresa purazi rezai (Shell Egg Producer Registration) nhamba.
Kana chikafu chakanyorwa papuratifomu yeAmazon, iwe uchakumbirwa kuti upe idzi nhamba dzekunyoresa.
2.cosmetic
Zvinoenderana neUS FDA cosmetics mirau uye nekuzvidira zvinodiwa pakunyoreswa kwezvizoro, makambani ezvekuzora anogona kunyoresa zvekuzora kuburikidza nemagetsi system VCRP kana kuendesa mapepa emapepa chigadzirwa chisati chatanga kana mushure mekutanga muUnited States. Mushure mekunyoresa, kambani ichange iine bhizinesi rekunyoresa (nhamba yekunyoresa), uye chigadzirwa formula nhamba (CPIS). Ruzivo rwunoda kupihwa nekambani runosanganisira ruzivo rwekambani (senge zita, kero, munhu anotarisira, ruzivo rwekutaura, nezvimwewo), ruzivo rwechigadzirwa (senge chiratidzo chekutengesa, fomula, nhamba yeCAS, nezvimwewo) .
Kana zvekuzora zvaiswa paAmazon papuratifomu, iwe unozokumbirwa kuti upe idzi nhamba dzekunyoresa.
3.medical zviridzwa
Iyo US FDA inokamura michina yekurapa kuita nhanho nhatu: Kirasi I, Kirasi II, uye Kirasi III zvichienderana nehuwandu hwenjodzi.
Zvigadzirwa zveKirasi l zvigadzirwa zvine njodzi yakaderera, uye zvizhinji zveKirasi I zvigadzirwa 510K zvisingabhadharwe zvigadzirwa. Chero bedzi makambani achinyoresa makambani avo uye zvinyorwa zvechigadzirwa neFDA, uye kuwana nhamba yekunyoresa, zvigadzirwa zvinogona kuiswa pamusika.
Zvakadai sezvishandiso zvakawanda zvekuvhiya, stethoscopes, midziyo yekurapa, machira ekuvhiya, makepisi ekuvhiya, masks, mabhegi ekuunganidza weti, nezvimwe.
Zvigadzirwa zveKirasi II zvigadzirwa zvine njodzi yepakati. Zvizhinji zveKirasi II zvigadzirwa zvinoda kunyorera kuti FDA 510K iiswe pamusika. Mushure mekuwana iyo nhamba ye510K, kunyoreswa kwebhizinesi uye kunyorwa kwechigadzirwa kunoitwa. Mushure mekuwana nhamba yekunyoresa, vanogona kuiswa pamusika (yakadzama sumo muchikamu 5 pazasi);
Zvakadai sema thermometers, blood pressure monitors, zvinoyamura kunzwa, oxygen concentrators, makondomu, acupuncture tsono, electrocardiographic diagnostic equipment, non-invasive monitoring equipment, optical endoscopes, portable ultrasonic diagnostic equipment, zvizere otomatiki biochemical analyzers, inogara tembiricha incubators, yakazara mazino kurapwa chiridzwa. , donje rinosveta zvekurapa, gauze rekurapa rinopinza, nezvimwe.
Kirasi III ine yakanyanya njodzi nhanho. Zvizhinji zveKirasi III zvigadzirwa zvinofanirwa kunyorera PMA zvisati zvaiswa pamusika. Chigadzirwa chacho chinofanira kuedzwa nekliniki. Mushure mekunge chigadzirwa chawana iyo PMA nhamba, kambani inofanirwa kunyoreswa uye chigadzirwa chichanyorwa. Mushure mekuwana nhamba yekunyoresa, inogona kuiswa pamusika;
Zvakadai seanodyarwa pacemakers, extracorporeal shock wave lithotripsy, invasive murwere yekutarisa masisitimu, intraocular lenses, invasive endoscopes, ultrasonic scalpels, color ultrasound imaging michina, laser yekuvhiya michina, yakakwira-frequency electrosurgery, microwave kurapwa Zvishandiso, zvekurapa MRI, kushandiswa kwepabonde kwekupinza. seti, seti yekuisira ropa, CT michina, nezvimwe.
Kana zvigadzirwa zvekurapa zvakanyorwa papuratifomu yeAmazon, ivo vanozodikanwa kuti vape nhamba yekunyoresa.
4.Drugs
Iyo FDA ine yakazara seti yezvitupa zvitupa zvezvigadzirwa zvemishonga kuti ive nechokwadi chekuchengetedza uye kushanda kwemishonga mitsva. Iyo inonyanya kuzivikanwa ndeyekutarisa paOTC mishonga uye kunyoresa NDC (National Drug Verification Number).
5.Chii chinonzi a510(k)? Kuita sei?
Kana chigadzirwa chakatemerwa kuve Kirasi II mudziyo wekurapa, 510 (k) faira inodiwa.
Iyo 510 (k) gwaro igwaro rekunyorera rekutanga musika rakatumirwa kuFDA. Chinangwa ndechekuratidza kuti mudziyo wakashandisirwa kushambadzira wakachengeteka uye unoshanda semudziyo unotengeswa zviri pamutemo usingakanganisike nepre-market approval (PMA), kureva kuti, mudziyo wakaenzana (zvakanyanya kuenzana). Munyoreri anofanirwa kuenzanisa chishandiso chakashandisirwa kushambadzira nechimwe kana zvimwe zvakafanana zvishandiso parizvino pamusika weUS, uye dhirowa nekutsigira mhedziso yekuti mudziyo wakaenzana.
五 Ndeupi ruzivo runodiwa kunyorera 510 (k) faira?
01 Tsamba yekunyorera
Kusanganisira ruzivo rwekutanga rwemunyoreri (kana munhu wekubata) nekambani, chinangwa che510 (K) kutumira, zita, modhi uye ruzivo rwemhando yemudziyo wakanyorerwa kunyorwa, zita rechigadzirwa (Predicate Chishandiso) kune yakakura. kuenzana kuenzanisa uye yayo 510(K) Nhamba;
02 Catalog
Ndiko kuti, runyoro rwese ruzivo rwuri mu510(k) faira (kusanganisira zvakabatanidzwa);
03 Kutendeseka Guarantee Chirevo
FDA inogona kuburitsa zviyero zvakajairwa;
04 Zita rekushandisa
Ndiko kuti, zita rechigadzirwa, FDA classification zita, uye chigadzirwa chekutengesa zita;
05 Kunyoresa nhamba
Kana iyo kambani yakanyoresa kambani painoendesa iyo 510 (K), ruzivo rwekunyoresa runofanira kupihwa. Kana iyo isina kunyoreswa, inofanirwawo kucherechedzwa;
06 Category
Ndiko kuti, boka rezvikamu, chikamu, nhamba yehutungamiri uye kodhi yechigadzirwa chechigadzirwa;
07 Maitiro Ekuita
Maitiro ekuita, zvinosungirwa kana zvekuzvidira zviyero zvinosangana nechigadzirwa;
08 Kuzivikanwa kwechigadzirwa
Kusanganisira emakambani ekurongedza marogo, mirairo yekushandisa, kurongedza accessories, zvigadzirwa zvinyorwa, nezvimwe;
09 SE
kuenzanisa kukuru;
10 Chirevo
510(k) Pfupiso kana Chirevo;
11 Product Description
Kusanganisira chigadzirwa chinotarisirwa kushandiswa, musimboti wekushanda, sosi yemagetsi, zvikamu, mapikicha, kudhirowa kwemaitiro, kudhirowa kwegungano, zvimiro zvehurongwa, nezvimwe;
12 Yakachengeteka uye inoshanda
Kuchengetedzwa kwechigadzirwa uye kushanda, kusanganisira kwakasiyana dhizaini uye yekuyedza data;
13 miedzo yenguva dzose
Biocompatibility; kugadzirwa kwechigadzirwa;
14 inoshanda
Mavara ekuwedzera (kana zvichibvira);
Kuongororwa kwesoftware (kana zvichibvira);
15 Kubereka vana
Sterilization (kana zvichibvira), kusanganisira tsananguro yenzira ye sterilization, sterilization verification chigadzirwa kurongedza uye kunyora, nezvimwe.
Zvinogona kuoneka kuti 510 (k) maitiro ekunyorera eKirasi II zvigadzirwa zvemishonga yekurapa akareba kwazvo, achitora ingangoita hafu yegore. Zvigadzirwa zvatinowanzo kunyorera FDA kunyoreswa ndezveChikamu 1, Chikamu 2 chinoda kunyorera 510(k), uye Chikamu 3 chakanyanya kuoma.
六 Ndeipi mibvunzo inowanzo bvunzwa nezve FDA kunyoresa?
• Nderipi sangano rinopa chitupa cheFDA?
Mhinduro: FDA kunyoresa haina chitupa. Chigadzirwa chinowana nhamba yekunyoresa nekunyoresa neFDA. Iyo FDA ichapa munyoreri tsamba yekupindura (ine siginicha yeFDA mukuru mukuru), asi hapana chitupa cheFDA.
• Ko FDA inoda kusarudzwacertified laboratory test?
Mhinduro: FDA isangano rekuchengetedza mutemo, kwete sangano rebasa. FDA haina masangano akatarisana neruzhinji ekupa zvitupa kana marabhoritari, uye haina "rabhoritari yakasarudzwa". Semubatanidzwa wezvemitemo wezvemitemo, iyo FDA haigone kuita zvinhu zvakadai semuridzi nemumhanyi. FDA inongoziva mhando yeGMP yemarabhoritari ekuongorora masevhisi uye kuburitsa zvitupa zvekuenderana kune vanokwanisa, asi haizo "sarudza" kana kukurudzira yakananga marabhoritari kana marabhoritari kune veruzhinji.
• Kunyoreswa kweFDA kunoda mumiriri weUS here?
Mhinduro: Hongu, vanyoreri veChinese vanofanirwa kudoma mugari weUS (kambani/sosaiti) semumiriri wavo kana vachinyoresa neFDA. Mumiririri ane basa rekuita masevhisi muUnited States uye ndiye murevereri pakati peFDA nemunyoreri.
• Nhamba yekunyoresa yeFDA inoshanda kwenguva yakareba sei?
Mhinduro: Hapana nguva yechokwadi yeUS chikafu giredhi mishumo. Chinodiwa chekunyorera zvakare rondedzero ndechekuti chigadzirwa chinoda kuendeswazve kuti chiongororwe kana chigadzirwa chachinja kana mirau yakagadziridzwa.
Iyo nguva yechokwadi yekunyoreswa kweFDA yezvishandiso zvekurapa kazhinji igore rimwe, naGumiguru 1st wegore rega rega semuganho. Kana ikashandiswa pamberi paGumiguru 1st, unofanirwa kubhadhara mubhadharo wekuvandudza pakati paGumiguru naZvita. Kana ikashandiswa mushure meGumiguru 1st, inofanirwa kuvandudzwa nemwedzi unotevera. Mari yekunyoresa inofanira kubhadharwa pakati paGumiguru naZvita wegore kuitira kuvandudzwa. Kana mubhadharo usina kubhadharwa nezuva rekupera, kunyoreswa kunenge kusiri kushanda.
• Ndeipi mhedzisiro yekusava nenhamba yeFDA yekunyoresa?
Mhinduro: Mhedzisiro huru ndeyekuti kana chikuva chikaziva, chinodzima zvakananga mvumo yekutengesa; chechipiri, iyo FDA inowanzo ongorora zvisina tsarukano pachikafu, zvinodhaka, uye zvizorwa zvinopinda muUnited States (yero yekuongorora isingaite i3-5%). Kana iyo isina kujairika yekuongorora samples inokodzera, iyo batch yezvigadzirwa inogona kuburitswa; kana masampuli ekuongorora asina kukodzera, batch "inosungwa".
Kana matambudziko akawanikwa panguva yekuongorora ari matambudziko akajairwa (akadai sezviratidzo zvisina kukodzera, nezvimwewo), mutengi anogona kubvumidzwa kuzvibata munharaunda uye obva azvisunungura mushure mekupasa kuongororwazve; asi kana matambudziko akawanikwa panguva yekuongorora ane hukama nehutano hwehutano nekuchengeteka, saka Hapana kusunungurwa kunobvumirwa. Inoda kuparadzwa munharaunda kana kutakurwa kudzokera kunyika inotengeswa kunze kwenyika, uye haigoni kuendeswa kune dzimwe nyika. Pamusoro pekuongorora zvisina tsarukano, iyo FDA inewo chiyero, ndiko kuti, zvigadzirwa zvinotengeswa kunze kwenyika zvine matambudziko angangodaro zvinofanirwa kuongororwa batch nebatch (panzvimbo yekuongorora zvisina tsarukano) kana ichipinda mutsika, inova "otomatiki detention" chiyero.
Nguva yekutumira: Zvita-22-2023