nkhani

Ulamuliro wa FDA pamagulu osiyanasiyana azida zamankhwala

Zofunikira za zilembo

“Kulembetsa fakitale kupanga chipangizo kapena kupeza nambala sikutanthauza kuvomereza fakitale kapena zinthu zake.Kufotokozera kulikonse komwe kumapangitsa kuganiza kuti kulembetsa kapena kupeza nambala yolembetsa kumabweretsa kuvomerezedwa ndi boma ndikosokeretsa ndipo kumakhala chizindikiritso cholakwika ”(21CFR 807.39)

Chidziwitso cha malonda ndi tsamba lawebusayiti zisaphatikizepo nambala yolembetsa ya kampani kapena kutchula kuti kampani yanu idalembetsedwa ndi FDA kapena yatsimikiziridwa.Ngati malongosoledwe omwe ali pamwambawa apezeka patsamba lazinthu kapena patsamba, akuyenera kuchotsedwa.

QSR820 ndi chiyani?

Code of Federal Regulations, Mutu 21

Gawo 820 Quality System Regulation

QSR imaphatikizapo njira zomwe zimagwiritsidwa ntchito pazida ndi zowongolera zomwe zimagwiritsidwa ntchito pakupanga zida zachipatala, kugula, kupanga, kuyika, kulemba zilembo, kusungira, kuyika, ndi ntchito.

Malinga ndi malamulo a 21CFR820, makampani onse a zida zamankhwala omwe amatumiza zinthu ku United States ndi Puerto Rico ayenera kukhazikitsa dongosolo labwino molingana ndi zofunikira za QSR.

Malinga ndi chilolezo cha FDA, CDRH ikonza oyendera kuti aziyendera mafakitale pakampaniyo.

Panthawi yolembetsa, kulembetsa mndandanda wazinthu, ndikupita poyera mukampani,

A FDA akuganiza kuti kampaniyo yakhazikitsa malamulo a machitidwe abwino;

Chifukwa chake, kuwunika kwa malamulo amachitidwe abwino nthawi zambiri kumachitika pambuyo poyambira;

Zindikirani: QSR 820 ndi ISO13485 sizingasinthidwe m'malo mwa wina ndi mnzake.

510 (k) ndi chiyani?

510 (k) imatanthawuza zikalata zaukadaulo zamsika zomwe zidatumizidwa ku US FDA katunduyo asanalowe mumsika waku US.Ntchito yake ndikuwonetsetsa kuti malondawo ali ndi chitetezo chofanana ndi chofanana ndi zinthu zomwe zimagulitsidwa movomerezeka pamsika waku US, zomwe zimadziwika kuti Substantially Equivalent SE, zomwe ndizofanana.

Zinthu zofanana kwambiri:

Kugwiritsa ntchito, kupanga, kugwiritsa ntchito kapena kutumizira mphamvu, zida, magwiridwe antchito, chitetezo, magwiridwe antchito, kulemba zilembo, kuyanjana kwachilengedwe, kutsata miyezo, ndi zina zomwe zikuyenera kugwiritsidwa ntchito.

Ngati chipangizo chomwe chikugwiritsidwa ntchito chili ndi cholinga chatsopano, sichingaganizidwe kukhala chofanana kwambiri.