FDA n’ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge muri Amerika. Nimwe mu nzego nyobozi zashyizweho na guverinoma y’Amerika mu ishami ry’ubuzima rusange (PHS) mu ishami ry’ubuzima n’ibikorwa bya muntu (DHHS). Inshingano ni ukurinda umutekano w’ibiribwa, kwisiga, ibiyobyabwenge, ibinyabuzima, ibikoresho by’ubuvuzi, n’ibicuruzwa bikoresha radiyo byakozwe cyangwa bitumizwa muri Amerika. FDA igabanijwemo ibice bibiri: kugerageza no kwiyandikisha. Ibikoresho byubuvuzi, kwisiga, ibiryo nibiyobyabwenge bisaba kwiyandikisha FDA.
一 Ni ubuhe bwoko bw'ibicuruzwa FDA ishinzwe?
Kugenzura no kugenzura ibiryo, ibiyobyabwenge (harimo imiti yubuvuzi bwamatungo), ibikoresho byubuvuzi, inyongeramusaruro, kwisiga, ibiryo byamatungo nibiyobyabwenge, ibinyobwa bya divayi birimo inzoga ziri munsi ya 7%, nibicuruzwa bya elegitoroniki; ion na non-ion byakozwe mugihe cyo gukoresha cyangwa gukoresha ibicuruzwa Kugerageza, kugenzura no kwemeza ingaruka zimirasire kubuzima bwabantu numutekano.
Uruhushya mpuzamahanga rwo kugurisha FDA ntabwo arirwo rwego rwo hejuru rwicyemezo cyo muri Amerika FDA, ahubwo ni icyemezo gikunze kugaragara ku biribwa n’ibiyobyabwenge byemejwe n’umuryango w’ubucuruzi ku isi (WTO). Nicyo cyonyine kigomba kwemezwa byimazeyo na FDA yo muri Amerika n’umuryango w’ubucuruzi ku isi mbere yuko gitangwa. Icyemezo. Iki cyemezo kimaze kuboneka, ibicuruzwa birashobora kwinjira mu gihugu icyo aricyo cyose cy’abanyamuryango ba WTO, ndetse n’uburyo bwo kwamamaza, guverinoma y’igihugu giherereye ntabwo yemerewe kwivanga.
Ni irihe tandukaniro riri hagati yo kwipimisha FDA, kwiyandikisha kwa FDA, no kwemeza FDA?
Ikizamini cya FDA
Mubisanzwe, kubicuruzwa biri mubyiciro bigenzurwa nkibikoresho byo guhuza ibiryo (nkibikombe byamazi, amacupa yumwana, ibikoresho byo kumeza, nibindi), kwisiga, ibiyobyabwenge, nibindi, raporo yikizamini cya FDA nayo irasabwa kwerekana ko ibicuruzwa byujuje ubuziranenge. Ikizamini cya FDA ni kwiyandikisha cyangwa kwiyandikisha, kandi nta cyemezo gitangwa.
• Kwiyandikisha kwa FDA
Kwiyandikisha kwa FDA mubyukuri byerekana uburyo bwo gutangaza ubunyangamugayo, ni ukuvuga, ababikora bashinzwe ibicuruzwa byabo byujuje ubuziranenge nibisabwa byumutekano, kandi biyandikisha kurubuga rwa leta zunzubumwe za Amerika. Niba hari ibitagenda neza kubicuruzwa, bagomba kwitwara neza. Kubwibyo, kubicuruzwa byinshi byanditswe na FDA, nta mpamvu yo kohereza ingero zo kwipimisha kandi nta cyemezo gitangwa.
Icyemezo cya FDA
Mu magambo make, nta cyemezo cya FDA. Iri ni imvugo isanzwe. Nukuri ni izina rusange ryo kwipimisha FDA no kwiyandikisha kwa FDA, byombi bishobora kwitwa icyemezo cya FDA.
Amazon Ese Amazon irashaka icyemezo cya FDA cyangwa kwiyandikisha kwa FDA?
Igenwa cyane cyane ishingiye kubicuruzwa. Mugihe urutonde rwibicuruzwa nkibikoresho byo guhuza ibiryo (ibikoresho byo mu gikoni, ibikombe byamazi, amacupa yumwana, nibindi), kwisiga, imiti, nibicuruzwa byubuzima kurubuga rwa Amazone muri Amerika, muri rusange ugomba gutanga raporo yikizamini cya FDA. Gusa shakisha ikigo cya gatatu cyipimisha cyemewe na Amazon kugirango ukore raporo zingirakamaro.
Ku masosiyete yohereza ibicuruzwa muri Amerika ibiryo, ibiyobyabwenge n’ibikoresho by’ubuvuzi, agomba kwiyandikisha muri FDA akanashyiraho urutonde rw’ibicuruzwa n’ibicuruzwa, bitabaye ibyo gasutamo ntizahanagura ibicuruzwa. Ni itegeko.
Ni ibihe byiciro bisanzwe byibicuruzwa kurubuga rwa Amazone?
1.Kwiyandikisha neza FDA
Ubwoko bwibicuruzwa byokurya byabantu birimo inzoga, ibicuruzwa, ibiryo, ibinyobwa, bombo, ibinyampeke, foromaje, shokora cyangwa cakao, ikawa cyangwa icyayi, amabara y'ibiryo, indyo isanzwe cyangwa gusimbuza amafunguro harimo ibiryo bivura imiti, ibiryo bikora (harimo n'imiti y'ibyatsi yo mu Bushinwa), ibyifuzo , ibicuruzwa byo mu mazi, inyongeramusaruro, ibijumba, imbuto nibicuruzwa byabo, geles, ice cream, kwigana amata yigana, makaroni, inyama, amata, umufa cyangwa jam, imbuto, amagi, imboga nibicuruzwa byabo, amavuta yimboga, inyama yigana, ifu cyangwa ibinyamisogwe, n'ibindi -ibicuruzwa bya azote bikomoka kuri poroteyine, ibikomoka ku butaka, imyanda y’inyamaswa zongera gukoreshwa, ibipapuro byerekana, vitamine, umusemburo, ibiryo by'amatungo, n'ibindi.
Izi sosiyete zita ku biribwa zigomba gutanga kwiyandikisha muri FDA yo muri Amerika kugirango zibone nomero ya FFRN (nimero yo kwiyandikisha mu biribwa) na PIN. Iyo usabye kwiyandikisha, umuntu uba muri Amerika agomba kugenwa nkintumwa ya Amerika.
Muri icyo gihe, buri myaka ibiri, nimero yambere yo kwiyandikisha ya FDA igomba kuvugururwa hagati ya 12:01 am ku ya 1 Ukwakira na 11:59 pm ku ya 31 Ukuboza umwaka urangira nimero imwe, bitabaye ibyo nimero yambere yo kwiyandikisha izaba bitemewe.
Kubiribwa bya acide nkeya hamwe na acide, usibye kwiyandikisha muri FDA kugirango ubone numero ya FFRN na PIN, bagomba kandi gutangaza uburyo bwabo bwo gutunganya kugirango babone Ikiranga (nomero ya SID).
Kubiribwa byubuzima, usibye kwiyandikisha muri FDA kugirango ubone nomero ya FFRN na PIN, ibicuruzwa byubuzima nabyo bigomba gutanga ibisabwa bikora. Ibigo bigomba gutanga ibyifuzo byimikorere muri FDA kugirango bisuzumwe kandi bitange mugihe cyiminsi 30 ibicuruzwa bitangijwe.
Imirima itera amagi, ikurikije ibisabwa n’amabwiriza 21 CFR 118.1 (a), ifite inkoko zirenga 3.000 kandi ntizigurisha amagi ku baguzi ku buryo butaziguye, kandi igomba kwiyandikisha muri FDA nk’umushinga. Ibigo bigomba kubanza kwiyandikisha mubucuruzi bwibiryo FDA bikurikije ibisabwa ninganda zisanzwe zibiribwa, hiyongereyeho numero ya FFRN na PIN, hanyuma bikandikisha nimero yumurima wamagi (Shell Egg Producer Registration).
Mugihe ibiryo byashyizwe kumurongo wa Amazone, uzasabwa gutanga iyi nimero yo kwiyandikisha.
Kwisiga
Dukurikije amabwiriza yo kwisiga yo muri Amerika FDA hamwe n’ibisabwa ku bushake kugira ngo yandike amavuta yo kwisiga, amasosiyete yo kwisiga ashobora kwandikisha amavuta yo kwisiga akoresheje sisitemu ya elegitoroniki VCRP cyangwa agatanga impapuro mbere cyangwa nyuma y’ibicuruzwa byatangijwe muri Amerika. Nyuma yo kwiyandikisha, isosiyete izaba ifite iyandikisha ryubucuruzi (nimero yo kwiyandikisha), numero yibicuruzwa (CPIS). Amakuru isosiyete ikeneye gutanga ikubiyemo amakuru yisosiyete (nkizina, aderesi, umuntu ubishinzwe, amakuru yamakuru, nibindi), amakuru yibicuruzwa (nk'ikirangantego, formula, ibikoresho fatizo CAS nimero, nibindi).
Iyo kwisiga bishyizwe kumurongo wa Amazone, uzasabwa gutanga iyi nimero yo kwiyandikisha.
3.ibikoresho byubuvuzi
FDA yo muri Amerika igabanya ibikoresho byubuvuzi mubyiciro bitatu: Icyiciro cya I, Icyiciro cya II, nicyiciro cya III ukurikije urwego rwibyago.
Ibicuruzwa byo mu rwego rwa l nibicuruzwa bifite ibyago bike, kandi ibicuruzwa byinshi byo mucyiciro cya mbere nibicuruzwa 510K bisonewe. Igihe cyose ibigo byandika ibigo byabo hamwe nu rutonde rwibicuruzwa hamwe na FDA, kandi bikabona nimero yo kwiyandikisha, ibicuruzwa birashobora gushyirwa ku isoko.
Nkibikoresho byinshi byo kubaga, stethoskopi, ibikoresho byubuvuzi, amakanzu yo kubaga, imipira yo kubaga, masike, imifuka yo gukusanya inkari, nibindi.
Ibicuruzwa byo mu cyiciro cya II nibicuruzwa byoroheje. Ibicuruzwa byinshi byo mu cyiciro cya II bigomba gusaba FDA 510K gushyirwa ku isoko. Nyuma yo kubona nimero 510K, kwandikisha ibigo no gutondekanya ibicuruzwa birakorwa. Nyuma yo kubona nimero yo kwiyandikisha, barashobora gushirwa kumasoko (intangiriro irambuye kumurongo wa 5 hepfo);
Nkibipimo bya termometero, monitor yumuvuduko wamaraso, ibyuma byumva, ibyuma bya ogisijeni, agakingirizo, inshinge za acupuncture, ibikoresho byo gupima electrocardiografique, ibikoresho byo kugenzura bidateye, ibikoresho bya endoskopi optique, ibikoresho byifashishwa mu gusuzuma indwara ya ultrasonic, isesengura ryihuse ryibinyabuzima, ibyuma byangiza amenyo, ibikoresho byose bivura amenyo , imiti ivura imiti, imiti ya gazi, nibindi.
Icyiciro cya III gifite urwego rwinshi rwibyago. Ibicuruzwa byinshi byo mu cyiciro cya III bigomba gusaba PMA mbere yo gushyirwa ku isoko. Igicuruzwa kigomba gukorerwa ibizamini byamavuriro. Ibicuruzwa bimaze kubona nimero ya PMA, isosiyete igomba kwiyandikisha kandi ibicuruzwa bigomba gushyirwa ku rutonde. Nyuma yo kubona nimero yo kwiyandikisha, irashobora gushyirwa kumasoko;
Nka pacemakers zatewe, lithotripsy ya extraitorporeal, sisitemu yo gukurikirana abarwayi itera, lens les intraocular, endoscopes, scalpels, ultrasonic scalpels, ibikoresho byo gufata amashusho ya ultrasound, ibikoresho byo kubaga lazeri, ibikoresho bya elegitoroniki yo kuvura, ibikoresho bya muganga bya MRI, gukoresha imibonano mpuzabitsina amaseti, gushiraho amaraso, ibikoresho bya CT, nibindi
Mugihe ibicuruzwa byubuvuzi byashyizwe kumurongo wa Amazone, bazasabwa gutanga nimero yo kwiyandikisha.
4.Ibiyobyabwenge
FDA ifite uburyo bwuzuye bwo gutanga ibyemezo byibicuruzwa bikoreshwa mu bya farumasi kugirango umutekano w’ibikorwa bishya bigerweho. Igikunze kugaragara cyane ni kwibanda ku biyobyabwenge bya OTC no kwandikisha NDC (Numero yigihugu yo kugenzura ibiyobyabwenge).
5.Ni iki a510 (k)? Nigute?
Niba ibicuruzwa byiyemeje kuba ibikoresho byubuvuzi byo mu cyiciro cya II, birasabwa gutanga 510 (k).
Inyandiko 510 (k) ninyandiko isaba mbere yisoko yashyikirijwe FDA. Ikigamijwe ni ukugaragaza ko igikoresho cyakoreshejwe mu kwamamaza gifite umutekano kandi gifite akamaro nkigikoresho cyacuruzwa mu buryo bwemewe n’amategeko kidafite ingaruka ku cyemezo kibanziriza isoko (PMA), ni ukuvuga ko ari igikoresho gihwanye (cyane cyane gihwanye). Usaba agomba kugereranya igikoresho cyakoreshejwe mu kwamamaza hamwe n’ibikoresho kimwe cyangwa byinshi bisa kuri ubu ku isoko ry’Amerika, kandi agashushanya kandi agashyigikira umwanzuro ko igikoresho gihwanye.
五 Ni ayahe makuru akenewe kugirango usabe dosiye 510 (k)?
01 Ibaruwa isaba
Harimo amakuru yibanze yabasabye (cyangwa umuntu wavugana) hamwe nisosiyete, intego yo gutanga 510 (K), izina, icyitegererezo hamwe namakuru yo gutondekanya ibikoresho byashyizwe kumurongo, izina ryibicuruzwa (Predicate Device) kubintu byinshi kugereranya kuringaniza numubare wacyo 510 (K);
02 Cataloge
Ni ukuvuga, urutonde rwamakuru yose akubiye muri dosiye 510 (k) (harimo imigereka);
03 Itangazo ryubwishingizi bwukuri
FDA irashobora gutanga ingero zisanzwe;
04 Izina ryibikoresho
Nukuvuga, ibicuruzwa bisanzwe, izina rya FDA, nizina ryubucuruzi;
05 Inomero yo kwiyandikisha
Niba isosiyete yiyandikishije isosiyete mugihe itanga 510 (K), amakuru yo kwiyandikisha agomba gutangwa. Niba itanditswe, igomba no kumenyekana;
06 Icyiciro
Nukuvuga, itsinda ryitsinda, icyiciro, nimero yubuyobozi hamwe nibicuruzwa byibicuruzwa;
07 Ibipimo ngenderwaho
Ibipimo ngenderwaho, itegeko cyangwa itegeko kubushake ibicuruzwa byujuje;
Kumenyekanisha ibicuruzwa
Harimo ibirango byo gupakira ibigo, amabwiriza yo gukoresha, ibikoresho byo gupakira, ibirango byibicuruzwa, nibindi.;
09 SE
kugereranya uburinganire bukomeye;
10 Itangazo
510 (k) Incamake cyangwa Itangazo;
11 Ibisobanuro ku bicuruzwa
Harimo ibicuruzwa bigenewe gukoreshwa, ihame ryakazi, isoko yimbaraga, ibice, amafoto, ibishushanyo mbonera, ibishushanyo mbonera, ibishushanyo mbonera, nibindi.;
12 Umutekano kandi neza
Umutekano wibicuruzwa nibikorwa neza, harimo ibishushanyo bitandukanye no gupima amakuru;
Ibizamini 13 bisanzwe
Biocompatibilité; imikorere y'ibicuruzwa;
14 birashoboka
Inyongera y'amabara (niba bishoboka);
Kugenzura software (niba bishoboka);
15 Kurimbuka
Kuringaniza (niba bishoboka), harimo gusobanura uburyo bwo kuboneza urubyaro, kugenzura ibicuruzwa bipfunyika hamwe na label, nibindi.
Birashobora kugaragara ko gahunda yo gusaba 510 (k) kubikoresho byubuvuzi byo mucyiciro cya kabiri ari birebire cyane, bifata hafi igice cyumwaka. Ibicuruzwa dusaba muri FDA kwiyandikisha mubyiciro 1, Icyiciro cya 2 bisaba gusaba 510 (k), kandi icyiciro cya 3 kiragoye.
Ni ibihe bibazo bikunze kubazwa kubyerekeye kwiyandikisha kwa FDA?
• Ni ikihe kigo gitanga icyemezo cya FDA?
Igisubizo: Kwiyandikisha kwa FDA ntabwo bifite icyemezo. Ibicuruzwa bizabona nimero yo kwiyandikisha wiyandikishije muri FDA. FDA izaha usaba ibaruwa isubiza (hamwe n'umukono w'umuyobozi mukuru wa FDA), ariko nta cyemezo cya FDA.
• Ese FDA isaba kugenwakwipimisha muri laboratoire?
Igisubizo: FDA nikigo gishinzwe kubahiriza amategeko, ntabwo ari ikigo cya serivisi. FDA ntabwo ifite ibigo byemeza serivisi rusange cyangwa laboratoire, nta nubwo ifite "laboratoire yabigenewe". Nkikigo gishinzwe kubahiriza amategeko, FDA ntishobora kwishora mubibazo nkumusifuzi numukinnyi. FDA izemera gusa ubuziranenge bwa GMP bwa laboratoire yo gupima serivisi kandi itange ibyemezo byerekana ko yujuje ibyangombwa, ariko ntabwo "izashyiraho" cyangwa ngo isabe rubanda cyangwa laboratoire yihariye.
• Kwiyandikisha kwa FDA bisaba umukozi wa Amerika?
Igisubizo: Yego, abasaba Ubushinwa bagomba gushyiraho umunyamerika (sosiyete / societe) nkumukozi wabo mugihe biyandikishije muri FDA. Intumwa ishinzwe gukora serivisi zikorwa muri Amerika kandi ni umuhuza hagati ya FDA nuwabisabye.
• Numero yo kwiyandikisha FDA ifite igihe kingana iki?
Igisubizo: Nta gihe cyemewe kuri raporo y'ibiribwa byo muri Amerika. Ibisabwa kugirango wongere usabe raporo ni uko ibicuruzwa bigomba kongera gutangwa kugirango bipimishe niba ibicuruzwa byahindutse cyangwa amabwiriza avugururwa.
Igihe cyemewe cyo kwiyandikisha kwa FDA kubikoresho byubuvuzi ni umwaka umwe, hamwe na 1 Ukwakira buri mwaka nkumupaka. Niba ikoreshwa mbere yitariki ya 1 Ukwakira, ugomba kwishyura amafaranga yo kongererwa hagati yUkwakira na Ukuboza. Niba ikoreshwa nyuma yitariki ya 1 Ukwakira, igomba kuvugururwa ukwezi gukurikira. Amafaranga yo kwiyandikisha agomba kwishyurwa hagati yUkwakira na Ukuboza umwaka kugirango yongere. Niba amafaranga atishyuwe nitariki yo kurangiriraho, kwiyandikisha bizaba impfabusa.
• Ni izihe ngaruka zo kutagira numero ya FDA?
Igisubizo: Ingaruka nini nuko niba urubuga rubimenye, ruzahagarika byimazeyo uruhushya rwo kugurisha; icya kabiri, muri rusange FDA ikora igenzura ridasanzwe kubiribwa, ibiyobyabwenge, no kwisiga byinjira muri Amerika (igipimo cyo kugenzura ni 3-5%). Niba icyitegererezo cyo kugenzura cyujuje ibyangombwa, icyiciro cyibicuruzwa gishobora kurekurwa; niba ibyitegererezo byubugenzuzi bitemewe, icyiciro "kizafungwa".
Niba ibibazo byavumbuwe mugihe cyigenzura aribibazo rusange (nkibimenyetso byujuje ibyangombwa, nibindi), uwatumije ibicuruzwa arashobora kwemererwa kubikemura mugace hanyuma akabirekura nyuma yo gutsinda ubugenzuzi; ariko niba ibibazo byavumbuwe mugihe cyigenzura bifitanye isano nubuziranenge bwubuzima n’umutekano, noneho Nta kurekurwa biremewe. Igomba gusenywa mu karere cyangwa ikajyanwa mu gihugu cyohereza ibicuruzwa hanze, kandi ntishobora kwimurirwa mu bindi bihugu. Usibye ubugenzuzi butunguranye, FDA ifite kandi ingamba, ni ukuvuga ko ibicuruzwa bitumizwa mu mahanga bifite ibibazo bishobora guterwa bigomba kugenzurwa nitsinda (aho kugenzurwa ku buryo butunguranye) igihe ryinjiye muri gasutamo, ni cyo cyemezo "cyo gufunga byikora".
Igihe cyo kohereza: Ukuboza-22-2023