Shanghai, Cuaj hlis 8, 2025 - raws li kev lag luam kho mob ntaus ntawv txuas ntxiv mus txuas ntiaj teb, nkag siab cov kev cai tswjfwm rau xws li covUS FDAthiabCov tiaj tus CECov ntawv pov thawj tau dhau los ua qhov tseem ceeb rau cov tuam ntxhab. Tuam txhab uas muag zoo liShanghai Huifeng Kho Mob Ntsuas Co., Ltd. (https://www.sh {- huaveng.com/), ib qho chaw tsim khoom lag luam ntawm high- Cov khoom siv kho mob zoo, yuav tsum ua raws cov kev cai no kom nkag mus hauv kev lag luam thoob ntiaj teb.
Teb Chaws Asmeskas FDA Daim Ntawv Pov Thawj: Ua kom muaj kev nyab xeeb thiab kev ua tau zoo
TusAsmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA)Cov khoom siv kho mob hauv qabTseem hwv cov zaub mov, tshuaj yeeb, thiab ua kom zoo nkaujCov. Cov khoom siv tau muab cais ua peb pawg raws li kev pheej hmoo:
- Chav kawm kuv (muaj pheej hmoo tsawg): Raug rau General tswj (piv txwv li, kev phais cov khoom).
- Chav Kawm Xyoo Tshiab (Kev Pheej Yig: Xav tau510 (K) Kev Ceeb Toom PremarketlossisPMA (Premarket pom zoo)(piv txwv li, kev ua twj (infusion).
- Chav kawm III (muaj pheej hmoo siab): Yuam kom nrujPaj NtawvVim lub neej -}} kev ua haujlwm (piv txwv li, pacemakers).
Cov tuam ntxhab yuav tsum rau npe lawv cov chaw, sau cov khoom, thiab ua raws liKev Cai Tswj Txoj Cai (QSR)hauv qab21 CFR Ntu 820Cov. Tsis - Ua raws cai tuaj yeem ua rau rov qab los yog kev ua lag luam.
EU CE Npav: Lub rooj sib tham MDR thiab ISDR Qauv
Hauv Tebchaws Europe, cov cuab yeej kho mob yuav tsum ua raws li covCov Ntawv Qhia Kho Mob (MDR 2017/745)lossisHauv kev tsim cov tshuaj vitro (IVDR 2017/746), hloov cov lus qhia dhau los. Cov kauj ruam tseem ceeb suav nrog:
- Ntaus Khoom Siv Ntaus Ntawv(Chav I, IIA, IIB, III) raws li kev pheej hmoo.
- Kev ntsuas kev caikoom nrog aQhia tawm lub cevRau siab dua - cov khoom siv pheej hmoo.
- Cov Ntaub Ntawv Kev Ua Haujlwmqhia kev nyab xeeb thiab kev ua yeeb yam ibKev Nyab Xeeb Kev Nyab Xeeb thiab Kev Ua Tau Zoo (GSPR).
- Post - Kev Ncig Xyuas Kev Ua Lag Luam (PMS)rau kev ua raws cai.
Huifeng Kev Cog Lus Kho Mob kom ua raws li
Shanghai Huifeng Kho Mob Ntsuas Co., Ltd. (https://www.sh {- huaveng.com/) tshwj xeeb hauvPov Tseg Kho Mob, suav nrog Txoj kev lis ntshav poob thiab koob txhaj tshuaj. Los ntawm adhering rauFDA thiab CE Txheej Txheem, HUIFAG ua kom nws cov khoom sib raws kev nyab xeeb thoob ntiaj teb thiab kev ua tau zoo, yooj yim kev lag luam hauv Asmeskas thiab EU.
Kws Muaj Txuj Ci:
"Navigating FDA thiab CE Cov kev tswjfwm tsis tas yuav muaj kev sib zog ua kom tau zoo rau kev tswj hwm zoo thiab cov ntaub ntawv," hais tias yog huifeng liam. "Peb peev hauv kev ua raws li peb txoj kev mob siab rau tus neeg mob kev nyab xeeb thiab kev sib tw thoob ntiaj teb."
Tag
Nrog Evolving cov kev cai, kev kho mob cov chaw tsim khoom lag luam yuav tsum muaj kev paub kom tswj kom ua raws li. Tuam txhab uas zoo li Huif kev kho mob kev kho mob yuav ua li cas muaj kev sib haum xeebFDA thiab CE Ua Haujlwmtuaj yeem tsav tsheb thoob ntiaj teb kev ua lag luam tau zoo thaum ua kom tus neeg mob kev nyab xeeb.
Kom paub meej ntxiv ntawm HUIFAG cov khoom lag luam uas muaj pov thawj, mus saib:
👉https://www.sh {- huaveng.com/
Media Hu:
Lisa Shao|+86-021-58084992 |
Email:Info@huifeng-co.com
Lub Vev Xaib:https://www.sh {- huaveng.com/