Iyo FDA yakapihwa ziviso yakanyorwa
FDA haabudise zvitupa zvekunyoresa kuZviratidzo zvekushandisa zvekurapa. FDA haatauri kunyoresa uye kunyora
ruzivo rwefemu dzakanyoreswa uye dzakanyorwa. Kunyoresa uye kunyorwa hazviratidze kubvumidzwa kubvumidzwa kana kubviswa kweiyo firm
kana michina yavo.
Nyaya dzatinoda kutarisisa kuFDA kunyoreswa ndizvo zvinotevera:
Mubvunzo 1: Ndeipi agency yakapa chitupa FDA?
A: Hapana chitupa cheFDA kunyoreswa. Kana chigadzirwa chakanyoreswa naFDA, iyo nhamba yekunyoresa ichawanikwa. FDA ichapa iye anonyorera tsamba yekupindura
Chiziviso chaFDA checherechedzo zvakadaro panguva ino chiyeuchidzo chakasimba! Nekuda kwekuvandudzwa kwechiripo kune mamiriro ezvinhu eUnited States, kudiwa kwechigadzirwa chekurapa kwekudzivirira kwekudzivirira chinotumirwa kuUnited States kwakawedzera, uye kudiwa kwekunyoreswa kwekunze kwakawedzera
Kana mamwe mabhizinesi anotevedzera FDA kuburitsa zvitupa kune vagadziri, mamwe mabhizinesi anogovera anogona kuwana fake "FDA zvitupa" pavanobvunza vagadziri.
Mubvunzo 2: FDA Inoda Rabhoritari Yakasimbiswa?
A: FDA ndeye mutemo wekusimbisa mutemo, kwete musangano webasa. Kana mumwe munhu akati ivo vari FDA Certification Laboratory, ivo vanonyengera vatengi, nekuti FDA haina basa reruzhinji
Zvepabonde zvitupa masangano nemarabherati, hapana anonzi "laboratori yakarongedzwa.". Semubatanidzwa wemubatanidzwa wekusimbisa mubatanidzwa, FDA haafanire kuve ari kuita zvinhu zvakadaro seanotungamira uye mutambi. FDA ichangobvunza chete basa
Iyo gmp mhando yemarabhoritari ichazivikanwa, uye imwe inokwanisa ichapihwa nechitupa, asi haizo "sarudzwa" kana kukurudzirwa kuruzhinji.
Mubvunzo 3: Ko FDA Kunyoreswa kunoda mumiririri weUS?
A: Ehe, bhizinesi rinofanira kugadza mugari weUS (Kambani / Association) Semumiriri wayo paunenge uchinyoresa naFDA. Iyo mumiririri ane mhosva yemasevhisi anoitwa muUnited States, ndeipi midhiya yekubata FDA uye iye anonyorera.
Zvikanganiso zvakajairika muFDA Kunyoresa
1. FDA Kunyoreswa kwakasiyana kubva kuCer Certification. Yayo Certification mode yakasiyana neCE Certification Chigadzirwa Kuedza + Kushuma Chitupa Mode. FDA Kunyoresa Chaizvoizvo anotora kutendeka kuzivisa maitiro, ndiko kuti, iwe une yakanaka yekutenda yekuzivisa maitiro ezvigadzirwa zvako
Mukuwirirana nezviyero zvakakodzera uye zvinodiwa zvekuchengetedza, uye zvakanyoreswa muUS federal webhusaiti, kana paine tsaona nechigadzirwa, ipapo inofanira kutakura mutoro unoenderana. Naizvozvo, FDA Kunyoreswa kwezvigadzirwa zvakawanda, hapana kutumira kwekutumira bvunzo
Uye chirevo chegwaro.
2. Nguva yekubvumidzwa yeFDA Kunyoresa: FDA Kunyoresa inoshanda kwegore rimwe. Kana iri rinopfuura gore rimwe, rinoda kuendeswa kunyoreswa, uye mubhadharo wepagore raisanganisirawo rinoda kubhadharwa zvakare.
3. FDA yakanyoreswa nechitupa?
Muchokwadi, hapana chitupa chekunyoresa FDA kunyoreswa. Kana chigadzirwa chakanyoreswa naFDA, iyo nhamba yekunyoresa ichawanikwa. FDA ichapa iye anonyorera tsamba yekupindura
Chitupa chatinowanzoona chakaburitswa neyekunyoreswa Agency
.
Maererano nemazinga akasiyana, FDA
FDA yakanyatsotsanangura zvakajeka kuiswa kwechigadzirwa uye manejimendi zvinodiwa kune yega yega yekurapa mudziyo. Parizvino, kune anopfuura mazana manomwe emhando dzemhando dzekurapa kabhodhi. Kana paine chero chokurapa chishandiso chichida kupinda mumusika weUS, chinofanira kutanga kujekesa kuiswa kwekurongedzwa uye manejimendi zvinodiwa zvezvigadzirwa zvinoshandiswa kushambadzira.
Mushure mekujekesa ruzivo pamusoro apa, bhizinesi rinogona kutanga kugadzirira zvinhu zvinoshandiswa zvekushandisa, uye taura nezve fda maererano nemaitiro ezvimwe nzira kuti awane mvumo. Kune chero chigadzirwa, mabhizinesi anoda kunyoresa uye zvinyorwa zvigadzirwa.
Yekirasi ini zvigadzirwa (accounting yeanenge 47%), kudzora kwakawanda kunoitwa. Iyo yakakura yakawanda yezvigadzirwa zvinongoda kunyoreswa, zvakanyorwa uye zvakanyorwa zviyero zveGMP, uye zvigadzirwa zvinogona kupinda mumusika weUS (vashoma kwazvo vakabatana neGMP)
Nhamba diki kwazvo yezvigadzirwa zvakachengeterwa zvinoda kuendesa 510 (K) application kuFDA, NAME PMN (Premarket Kuzivisa));
Kune kirasi ii zvigadzirwa (accounting kweanosvika 46%), kutonga kwakakosha kunoitwa. Mushure mekunyoreswa uye kunyora, mabasa anodiwa kuti aise GMP uye kuendesa 510 (K) application (zvigadzirwa zvishoma ndeye 510 (k) kuregererwa);
Kune kirasi III zvigadzirwa (anenge 7%), pre yekushambadzira rezinesi rinoitwa. Mushure mekunyoreswa uye kunyora, mabhizinesi anofanirwa kuita gmp uye kuendesa PMA (Premarket application) application kuenda kuFDA (Chikamu III)
PMN).
Kwekirasi ini zvigadzirwa, mushure mekunge bhizinesi rinoburitsa ruzivo rwakakodzera kuFDA, FDA zvinongoita chiziviso, uye hapana chitupa chakakodzera chinopihwa kune bhizinesi; yekirasi II uye III Midziyo, Enterprise inofanira kuendesa PMN kana PMA, uye FDA Ichavo
Ipa bhizinesi remubhadharo musika wekuwana tsamba tsamba, kureva kuti, bvumira bhizinesi rekutengesa zvakananga zvigadzirwa muUS Medical mudziyo musika muZita rayo.
Kunyangwe kuenda kune Enterprise yeGMP kuongorora mune yekunyorera maitiro inosarudzwa neFDA maererano neiyo Chigadzirwa Ngozi Level, manejimendi zvinodiwa nemusika mhinduro uye zvimwe zvinhu zvakazara.
Kubva pane zviri pamusoro, tinogona kuona kuti zvigadzirwa zvakawanda zvinogona kuwana FDA CRECTION mushure mekunyoresa, chigadzirwa chekunyora kweGMP zvekushandisa zvekurapa, kana kutumira kwe510 (K) application.
Maitiro ekutarisa kuti chigadzirwa chave chakanyorwa naFDA) kana kunyoreswa mu510k?
Iyo chete inonyanyopa nzira: Tarisa pane iyo FDA webhusaiti
Kutumira Nguva: Jan-09-2021