Ukudla nokudla kwezidakamizwa (FDA)

I-Food and Drug Administration (FDA) inesibopho sokuvikela impilo yomphakathi ngokuqinisekisa ukuphepha, ukusebenza kahle kwezidakamizwa, imikhiqizo yezokwelapha, ukuhlinzekwa kwezimo zezokwelapha, kanye nemikhiqizo ekhipha imisebe. I-FDA futhi ihlinzeka ngemininingwane enembile, esekwe kwisayensi emphakathini.

I-FDA ibonwa ngamazwe amaningi

l I-United States: Isitifiketi se-FDA siyisidingo esiyisisekelo sokuthengisa ukudla, izidakamizwa, amadivaysi ezokwelapha neminye imikhiqizo ku-U.S. imakethe.

l ECanada: ICanada eyamukelwa ngokuvamile isitifiketi se-FDA njengophawu olubalulekile lokufakazela ikhwalithi yomkhiqizo nokulandela umthetho.

l I-Europe: Yize i-Europe inohlelo lwayo lokuqinisekiswa kwalo, isitifiketi se-FDA kwesinye isikhathi lubonwa njengenzuzo eyengeziwe ngoba imele ukuthi umkhiqizo uhlangabezana namazinga aphezulu futhi usiza ekutholeni ukwamukelwa emakethe yaseYurophu.

l E-Eshiya: Amazwe ase-Asia afaka China, Japan, South Korea namanye amazwe avame ukwamukela imikhiqizo eqinisekisiwe ye-FDA, ikakhulukazi amadivaysi ezokwelapha kanye nezidakamizwa.

l ENingizimu Melika: Amazwe amaningi aseNingizimu Melika abuye abone isitifiketi se-FDA futhi asibheke njengesiqinisekiso sekhwalithi yomkhiqizo.

Ukuhlukaniswa kwamadivayisi wezokwelapha

I-FDA ihlukanisa amadivaysi ezokwelapha kwelinye lamakilasi amathathu – Ikilasi I, II, noma i-III – Ngokusekelwe ebungozini abo nasezilawulweni zokulawula ezidingekayo ukuhlinzeka ngokuqiniseka okunengqondo kokuphepha kanye nokusebenza ngempumelelo. Amadivayisi I-Class I amadivayisi ngokuvamile abeka engcupheni ephansi kakhulu kwisiguli kanye / noma amadivayisi weklasi nama-III abeka engcupheni ephezulu kakhulu.

I-Sunsired yi-FDA Isigaba II sibhalisiwe 

I-Sunsred ingumkhiqizi oqeqeshiwe ogxile emkhiqizweni weRed Light Therapy Therapy (RLT), ungowamadivayisi wezokwelapha, siyi-FDA Class Kubhaliswe

Imvamisa, amaklayenti  ingabheka imininingwane yokubhalisa ye-FDA ngesixhumanisi esingezansi , vele uthayiphe ikhodi yomnikazi / opharetha bese useshe Lapho-ke unga mphumela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm

Uma kukhona eminye imibuzo Sicela uxhumane nomqondisi wethu wokuthengisa nge   ushikukazi Ahannah @ ushikukazi assyred. c amathize ,  Ngiyabonga.