Dab tsi yog Cov Txheej Txheem Rau Exporting Qhov ncauj qhov ntswg rau txawv teb chaws

Export rau Tebchaws Meskas

US Food and Drug Administration (FDA) tau teev tseg tias cov khoom siv kho mob, zaub mov, cawv, tshuaj thiab lwm lub chaw ua haujlwm sab nraum Tebchaws Meskas yuav tsum tau sau npe thiab ib tus neeg sawv cev hauv tebchaws Meskas yuav tsum raug xaiv ua ntej lawv teev npe hauv Tebchaws Meskas.

21CFR Tshooj 807.40 (A) qhia tias ib qho chaw tsim khoom txawv teb chaws Asmeskas koom nrog hauv kev tsim, npaj, ua ke lossis ua tiav cov khoom siv kho mob thiab xa khoom tuaj rau Tebchaws Meskas yuav tsum tau ua tiav Daim Ntawv Tso Cai Tsim Kho thiab Cov Ntawv Kho Mob.Thaum tso npe rau lub Hoobkas, cov chaw tsim khoom yuav tsum tau tshaj tawm cov ntaub ntawv ntawm US tus neeg sawv cev rau FDA hauv daim ntawv hluav taws xob hauv kev sau npe thiab sau npe (FURLS system), suav nrog lub npe, chaw nyob, xov tooj, fax thiab email ntawm US tus neeg sawv cev.

Rau txhua yam khoom, cov lag luam yuav tsum tau sau npe thiab sau cov khoom.

Rau Chav Kawm I cov khoom lag luam (suav txog li 47%), Kev Tswj Xyuas Kev Tswj Xyuas yog siv.Feem ntau ntawm cov khoom tuaj yeem nkag mus hauv Asmeskas kev lag luam tsuas yog los ntawm kev sau npe, sau npe thiab siv GMP cov lus qhia tshwj xeeb (ob peb ntawm lawv raug zam los ntawm GMP, thiab qee qhov ntawm cov khoom tshwj tseg yuav tsum xa 510 (K) daim ntawv thov rau FDA, piv txwv li PMN (Kev Ceeb Toom Ua Ntej. ));

Export rau Nyiv

Cov tuam txhab kho mob uas xav tso lawv cov khoom lag luam hauv Nyij Pooj yuav tsum ua kom tau raws li cov cai ntawm Japanese Pharmaceutical And Medical Device Act (PMD Act).

Yog tias cov tuam txhab kho mob xav muab lawv cov khoom lag luam tso rau hauv Nyij Pooj Lag Luam, lawv yuav tsum ua kom tau raws li Txoj Cai Kho Mob thiab Kev Kho Mob (PMD Act) ntawm Nyiv.

Pharmaceutical and Medical Devices Agency (PMDA), ib lub koom haum subordinate ntawm Ministry of Health, Labor thiab Welfare (MHLW), kuj tau luam tawm ib tug me me ntawm cov kev cai ua lus Askiv.Txawm li cas los xij, teeb meem lus thiab cov txheej txheem ntawv pov thawj nyuaj tseem yog qhov nyuaj rau kev sau npe khoom siv kho mob hauv Nyij Pooj.

Raws li cov cai ntawm PMD Txoj Cai, TOROKU cov ntawv sau npe yuav tsum muaj cov tuam txhab tsim khoom hauv tsev sau npe cov ntaub ntawv hauv lub Hoobkas nrog cov neeg muaj peev xwm hauv zos tau tso cai los ntawm tsoomfwv, suav nrog cov khoom tsim, kev tsim khoom thiab cov ntaub ntawv tseem ceeb;Cov tuam txhab txawv teb chaws yuav tsum sau npe cov ntaub ntawv tsim khoom nrog PMDA.

Raws li qhov kev thov ntawm PMD Act, Toroku Registration System xav kom cov neeg tsim khoom hauv tsev sau npe rau cov ntaub ntawv Hoobkas nrog cov cai hauv zos tau tso cai los ntawm tsoomfwv, suav nrog cov khoom tsim, kev tsim khoom thiab cov ntaub ntawv tseem ceeb;Cov neeg tsim khoom txawv teb chaws yuav tsum sau npe cov ntaub ntawv chaw tsim khoom nrog PMDA.

Export rau South Kauslim

Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (MHW) hauv Kaus Lim Qab Teb, hu ua Ministry of Health luv luv, yog lub luag haujlwm tseem ceeb rau kev tswj hwm zaub mov, tshuaj, tshuaj pleev ib ce thiab khoom siv kho mob, thiab yog lub luag haujlwm tseem ceeb hauv kev saib xyuas kev noj qab haus huv.Raws li Txoj Cai Kho Mob Kho Mob, Ministry of Food and Drug Safety (MFDS) nyob rau hauv Ministry of Health thiab Welfare ntawm South Kauslim yog lub luag haujlwm rau kev saib xyuas cov cuab yeej kho mob.

Txoj Cai Kho Mob Kaus Lim Kauslim tau faib cov cuab yeej kho mob ua plaub pawg (I, II, III, IV), uas zoo ib yam li European Union cov kev faib khoom siv kho mob.

Korean Medical Devices Law faib cov cuab yeej kho mob ua plaub pawg (I, II, III thiab IV), uas zoo ib yam li European Union qhov kev faib tawm ntawm cov cuab yeej kho mob.

Chav Kawm I: cov khoom siv kho mob uas muaj kev phom sij me ntsis;

Chav Kawm II: cov khoom siv kho mob uas muaj kev phom sij tsawg;

Chav Kawm III: cov khoom siv kho mob uas muaj peev xwm txaus ntshai;

Chav Kawm IV: Cov khoom siv kho mob uas pheej hmoo siab.

Kev faib tawm ntawm cov khoom siv kho mob: kev pheej hmoo siab, thaj chaw tiv tauj thiab lub sijhawm nrog tib neeg lub cev, kev nyab xeeb thiab kev ua tau zoo ntawm cov khoom.

Cov cuab yeej siv Class I thiab II yuav tsum tau lees paub los ntawm "Medical Device Information Technology Support Center (MDITAC)", thiab qee qhov Class II (cov cuab yeej tshiab), Chav Kawm III thiab Chav Kawm IV yuav tsum tau pom zoo los ntawm Korean Food and Drug Safety Administration.

Tag nrho cov khoom siv kho mob xa tawm mus rau Australia yuav tsum tau thov rau npe TGA.TGA yog lub npe luv ntawm Kev Kho Cov Khoom Siv Kho Mob.Nws lub npe tag nrho yog Therapeutic Goods Administration.Nws yog lub chaw saib xyuas cov khoom siv kho mob (xws li tshuaj, khoom siv kho mob, genetic technology thiab cov khoom siv ntshav) hauv Australia.

Lub ntsiab lus ntawm cov cuab yeej kho mob hauv Australia yog nyob ze rau CE ntawm EU, thiab kev faib tawm yog qhov sib xws.Sib txawv ntawm US FDA, hom tsiaj tsis raug tswj los ntawm TGA.Zoo ib yam li FDA, koj yuav tsum qhia cov tiam