Tshooj Lus 1" Txhawm rau tswj hwm cov lus qhia thiab cov ntawv cim ntawm cov cuab yeej siv kho mob thiab ua kom muaj kev nyab xeeb ntawm cov cuab yeej siv kho mob, cov cai no tau tsim raws li Txoj Cai ntawm Kev Saib Xyuas thiab Kev Tswj Xyuas Cov Khoom Siv Kho Mob.
Tshooj 2 Txhua cov cuab yeej siv kho mob muag thiab siv nyob hauv thaj chaw ntawm Cov Neeg' s koom pheej ntawm Tuam Tshoj yuav tsum nrog cov lus qhia thiab daim ntawv lo nrog ua raws li cov cai ntawm cov cai no.
Tshooj Lus 3 phau ntawv qhia txog khoom siv kho mob yog hais txog cov cuab yeej sau npe kho mob lossis cov ntawv kaw, uas tsim tawm los ntawm cov cuab yeej siv kho mob lossis cov ntawv kaw, thiab muab rau tus neeg siv cov khoom lag luam, npog cov ntaub ntawv tseem ceeb hais txog kev nyab xeeb thiab ua tau zoo ntawm cov khoom siv los coj muaj tseeb teeb tsa, kev debugging, kev ua haujlwm, kev siv, kev txij nkawm, thiab kev siv tshuab ua haujlwm.
Daim ntawv cim cov khoom kho mob yog hais txog cov lus piav qhia, cov duab kos, thiab cov cim uas txuas nrog cov cuab yeej kho mob lossis nws ntim khoom txhawm rau txheeb xyuas cov khoom nta thiab taw qhia cov lus ceeb toom kev nyab xeeb thiab lwm cov ntaub ntawv.
Tshooj 4 Cov ntsiab lus ntawm cov khoom siv kho mob cov lus qhia thiab cov ntawv sau yuav tsum muaj kev tshawb fawb, muaj tseeb, ua tiav, raug, thiab muaj raws li cov yam ntxwv ntawm cov khoom.
Cov ntsiab lus ntawm phau ntawv thiab daim ntawv lo ntawm cov cuab yeej kho mob yuav tsum muaj feem nrog cov ntsiab lus muaj npe tau sau lossis cov ntawv foob.
Cov ntsiab lus ntawm cov ntawv kho mob ntaus cim yuav tsum muaj raws li cov ntsiab lus tseem ceeb ntawm phau ntawv.
Tshooj Lus 5 Cov lus piav qhia txog cov npe ntawm tus kab mob, cov lus tshaj lij, kev kuaj mob thiab txheej txheem kev kho mob thiab cov txiaj ntsig ntawm cov lus qhia kho mob thiab cov ntawv sau yuav tsum lees txais cov lus tshwj xeeb los yog tsim qauv hauv lub xeev, thiab chav ntsuas ntawm cov ntsuas yuav tsum ua raws li cov qauv hauv tebchaws.
Tshooj Lus 6 Cov cim los yog cov cim xim uas siv hauv cov lus qhia thiab cov ntawv cim ntawm cov cuab yeej siv kho mob yuav tsum ua raws li cov qauv hauv tebchaws uas tsim nyog; yog tias tsis muaj cov qauv uas cuam tshuam, cov cim thiab cov cim xim yuav tsum tau piav qhia hauv cov lus qhia.
Tshooj 7 Kev muag khoom tsawg kawg nkaus ntawm cov cuab yeej siv kho mob yuav tsum nrog cov lus qhia.
Cov neeg siv kho mob cov cuab yeej siv yuav tsum siv cov cuab yeej kho mob ua raws li cov lus qhia.
Tshooj 8 Cov npe khoom lag luam ntawm cov khoom siv kho mob yuav tsum yog cov npe siv dav dav, thiab cov npe tsis raug yuav tsum ua raws li cov cuab yeej siv tshuaj kho mob uas tsim los ntawm Lub Xeev Khoom Noj thiab Tshuaj. Cov khoom lag luam ntawm Class II thiab Class III cov cuab yeej siv kho mob yuav tsum zoo ib yam nrog cov npe khoom lag luam hauv daim ntawv pov thawj khoom kho mob.
Cov khoom lag luam yuav tsum raug cim meej meej nyob hauv txoj haujlwm tseem ceeb hauv phau ntawv thiab phau ntawv lo.
Tshooj 9 Cov lus qhia kho mob cov khoom siv thiab cov ntawv cim cov ntsiab lus yuav tsum yog ua lus Suav, thiab kev siv lus Suav yuav tsum ua raws li lub teb chaws tus qauv ntawm cov lus thiab sau ntawv. Cov lus qhia kho mob ntaus cim thiab cov ntawv lo tuaj yeem txuas ua lwm hom lus, tab sis lus Suav yuav tshwm sim.
Cov ntawv, cov cim, cov ntaub ntawv, cov lej, cov duab, thiab lwm yam hauv cov lus qhia thiab cov ntawv ntawm cov cuab yeej siv kho mob yuav tsum yog qhov tseeb, meej thiab muaj qauv.
Tshooj 10 lus qhia txog khoom kho mob feem ntau yuav tsum muaj cov hauv qab no:
(1) Khoom npe, qauv, qhov tshwj xeeb;
(2) Lub npe, domicile, cov ntaub ntawv tiv tauj thiab chav pabcuam tomqab muag khoom ntawm tus neeg sau npe lossis tus neeg ua ntawv foob, thiab cov khoom siv khomob kho mob yuav tsum qhia lub npe, domicile thiab cov ntaub ntawv tiv tauj ntawm tus neeg sawv cev;
(3) Lub npe, domicile, chaw nyob ntau lawm, cov ntaub ntawv tiv toj, thiab tus naj npawb daim ntawv tso cai lossis daim ntawv pov thawj kev tsim cov ntawv pov thawj ntawm cov chaw tsim khoom. Yog hais tias ntau lawm yog tus tso siab, lub npe, domicile, chaw nyob ntau lawm, daim ntawv tso cai ntau lawm lossis cov ntawv thov ntau lawm ntawm cov lag luam muab tso tawm yuav tsum tau ntaus cim Tus lej;
(4) Kev ntaus cov ntawv pov thawj kho mob tus xov tooj lossis daim ntawv thov daim ntawv pov thawj;
(5) Tus naj npawb ntawm cov khoom lag luam xav tau;
(6) Cov khoom lag luam ua tau zoo, cov qauv sib txuas tseem ceeb lossis cov muaj pes tsawg leeg, thiab cov haujlwm ntawm daim ntawv thov;
(7) Kev cuam tshuam tsis zoo, muaj kev ceev faj, ceeb toom thiab nco;
(8) Kev teeb tsa thiab siv cov lus qhia lossis duab, cov cuab yeej siv kho mob siv los ntawm cov neeg siv lawv tus kheej yuav tsum muaj cov lus qhia tshwj xeeb rau kev siv nyab xeeb;
(9) Kev tswj hwm cov khoom lag luam thiab kev saib xyuas, cov khoom tshwj xeeb thiab kev thauj mus los thiab cov hau kev;
(kaum) hnub ntau lawm, hnub tas sijhawm lossis hnub tas sijhawm;
(11) Cov npe ntu, suav nrog cov khoom siv, cov khoom siv hloov chaw, kev hloov pauv ntawm qhov qub ntawm hnav thiab cov lus qhia rau kev hloov txheej txheem, thiab lwm yam;
(12) Kev piav qhia cov duab kos, cov cim, cov ntawv luv thiab lwm cov ntsiab lus siv hauv cov ntawv kho mob;
(13) Hnub tim muab tso ua ke lossis kho ntawm phau ntawv;
(14) Lwm cov ntsiab lus uas yuav tsum khij.
Tshooj 11 Cov kev ceev faj, ceeb toom thiab ceeb toom hauv phau ntawv kho mob phau ntawv feem ntau suav nrog:
(1) Lub homphiaj uas cov khoom lag luam siv;
(2) Muaj kev phom sij txaus ntshai thiab kev txwv kev siv;
(3) Thaum muaj xwm txheej tshwm sim thaum lub sijhawm siv cov khoom raug, kev tiv thaiv kev tiv thaiv rau tus neeg teb xov tooj thiab tus neeg siv, nrog rau cov xwm txheej ceev thiab kev tiv thaiv uas yuav tsum tau ua;
(4) Kev tshuaj xyuas tsim nyog, kev tshuaj ntsuam xyuas, thiab kev tswj;
(5) Cov khoom pov tseg yuav tsum khij nrog cov lus" ib zaug siv" lossis cov cim, cov khoom lag luam kom tsis muaj menyuam yuav tsum khij nrog txoj kev ua kom tsis huv thiab cov txheej txheem kev kho mob tom qab pob kom tsis muaj menyuam lawm, thiab cov tshuaj tua kab mob los yog kom tsis muaj menyuam yuav tsum tau hais ua ntej siv. Los yog txoj kev ua kom tsis muaj menyuam;
(6) Thaum cov khoom lag luam yuav tsum tau txhim kho los yog siv ua ke nrog lwm cov cuab yeej kho mob, qhov yuav tsum ua, kev siv thiab kev ceev faj ntawm kev sib koom tes ntawm cov cuab yeej yuav tsum tau qhia;
(7) Hauv kev siv, muaj kev cuam tshuam sib cuam tshuam nrog lwm cov khoom lag luam thiab tsim kev phom sij;
(8) Cov xwm txheej tsis zoo uas yuav tshwm sim los ntawm kev siv cov khoom lossis cov khoom xyaw lossis cov tsis muaj nyob hauv cov khoom xyaw uas yuav ua rau muaj kev phiv tshuaj;
(9) Cov teeb meem uas yuav tsum tau them sai sai rau thaum pov tseg cov cuab yeej kho mob, yog tias cov khoom lag luam xav tau pov tseg tom qab siv tas, cov txheej txheem kho yuav tsum raug qhia;
(10) Raws li cov yam ntxwv ntawm cov khoom, tus neeg teb xov tooj thiab cov neeg siv yuav tsum nco qab txog lwm yam.
Tshooj 12 Cov cuab yeej siv kho mob yuav tsum qhia meej cov txheej txheem kev kho mob ntawm kev siv rov qab rau hauv cov lus qhia, suav nrog cov hau kev ntawm kev ntxuav, kev tua tus kab mob, ntim khoom thiab kom tsis muaj menyuam, thiab tus lej ntawm kev siv dua lossis lwm yam kev txwv.
Tshooj 13 Cov ntawv kho mob ntaus ntawv feem ntau yuav suav nrog cov hauv qab no:
(1) Khoom npe, qauv, qhov tshwj xeeb;
(2) Lub npe, chaw nyob, thiab cov ntaub ntawv tiv toj ntawm tus neeg sau npe lossis tus neeg foob. Cov khoom siv kho mob tseem yuav tsum muaj lub npe, chaw kho mob thiab kev tiv tauj rau ntawm tus neeg sawv cev;
(3) Kev ntaus cov ntawv pov thawj kev kuaj mob tus naj npawb lossis cov ntawv thov daim ntawv pov thawj;
(4) Lub npe, domicile, chaw nyob ntau lawm, cov ntaub ntawv tiv toj, thiab tus lej thov daim ntawv tso cai lossis daim ntawv thov daim ntawv pov thawj ntawm tus tswv lag luam. Yog hais tias ntau lawm yog entrusted, lub npe, domicile, chaw nyob ntau lawm, daim ntawv tso cai ntau lawm lossis ntau lawm daim ntawv pov thawj ntawm cov lag luam entrusted yuav tsum tau qhia Tus lej;
(5) hnub ntau lawm, siv sijhawm lossis hnub tas sijhawm;
(6) Lub zog txuas kev sib txuas lus, cov tswv yim fais fab;
(7) Cov duab, cov cim thiab lwm cov ntsiab lus muaj feem xyuam uas yuav tsum tau cim raws li cov khoom lag luam;
(8) Cov lus ceeb toom ceeb toom thiab kev ceev faj;
(9) Kev cia tshwj xeeb, kev ua haujlwm lossis cov lus qhia;
(10) Rau cov cuab yeej siv kho mob uas tsim kev puas tsuaj rau ib puag ncig lossis muaj kev cuam tshuam tsis zoo rau ib puag ncig hauv kev siv, lawv cov ntawv cim yuav tsum muaj daim paib qhia lossis cov lus qhia ceeb toom hauv Suav;
(11) Rau cov cuab yeej siv kho mob uas nqa hluav taws xob lossis hluav taws xob, lawv cov ntawv yuav tsum muaj cov paib qhia lossis ceeb toom cov lus qhia ua lus Suav.
Yog tias cov cuab yeej siv tshuaj kho mob tsis tuaj yeem qhia tag nrho cov ntsiab lus saum toj no vim qhov chaw lossis qhov txwv qhov tsawg, tsawg kawg ntawm cov khoom lag luam npe, qauv, kev qhia meej, hnub tsim tawm thiab hnub tas sij hawm yuav tsum tau qhia, thiab cov ntawv sau yuav tsum qhia meej" saib cov lus qhia rau lwm cov ntsiab lus."
Tshooj 14 lus qhia txog khoom kho mob thiab cov ntawv lo yuav tsum tsis txhob muaj cov ncauj lus hauv qab no:
(1) Muaj kev lees paub lossis kev lav paub ntawm kev ua tau zoo xws li" cov txiaj ntsig zoo" ;," lav kho"," suav kev kho" ;," kho tau" ;," nrawm" ;," tsis muaj kuab lom cuam tshuam los ntawm" ;, thiab lwm yam.;
(2) Cov lus tsis raug thiab cov kev hais tawm xws li" technology siab tshaj" ;," feem ntau" feem ntau," thiab" zoo tshaj" ;;
(3) Lub xeev kho tus nqi lossis siv tau;
(4) Piv nrog rau qhov ua tau zoo thiab kev nyab xeeb ntawm lwm cov tuam txhab' cov khoom lag luam;
(5) Muaj cov lus cog tseg xws li" kev tuav pov hwm lub tuam txhab" ;," tsis siv nyiaj rov qab" thiab yog li ntawd;
(6) Siv lub npe lossis duab ntawm ib qho lossis ib tus kheej siv los ua pov thawj lossis kev pom zoo;
(7) Muaj cov lus teev tsis tseeb uas ua rau tib neeg xav tias lawv tau mob los ntawm qee yam kabmob, lossis nkag siab yuam kev tias tsis siv cov khoom kho mob yuav ua rau muaj qee yam kabmob lossis ua rau tus kabmob hnyav dua, thiab lwm yam tsis raug, hais tsis meej, thiab cov ntsiab lus tsis raug;
(8) Lwm cov ntsiab lus txwv tsis pub ua los ntawm cov cai thiab cov cai.
Tshooj 15 Cov lus qhia txog khoom kho mob yuav tsum raug xa mus rau Chaw Tswj Xyuas Khoom Noj thiab Yeeb Tshuaj kom tshuaj xyuas los ntawm tus neeg thov cuv npe lossis tus khaws ntaub ntawv thaum cov ntawv kho mob sau npe lossis xa. Cov ntsiab lus ntawm cov lus qhia uas tau xa yuav tsum yog nrog lwm cov ntawv sau npe lossis cov ntawv thov.
Tshooj 16 Cov ntsiab lus ntawm cov lus qhia ntawm cov khoom siv kho mob uas tau sau npe thiab tshuaj xyuas los ntawm Food and Drug Administration yuav tsis hloov pauv yam tsis tau txais kev tso cai.
Yog tias muaj kev hloov npe rau cov ntawv kho mob sau npe, tus neeg thov yuav tsum hloov cov lus qhia thiab daim ntawv lo npe raws li hloov chaw tom qab muab cov ntaub ntawv pauv hloov.
Yog tias muaj kev hloov pauv hauv lwm cov ncauj lus ntawm phau ntawv, yuav tsum sau ntawv ceeb toom mus rau chav tso cai pom zoo ntawm cov ntawv sau npe kho mob, thiab cov ntaub ntawv muaj feem cuam tshuam xws li kev piav qhia kev hloov pauv ntawm phau ntawv yuav tsum xa. Yog tias lub chaw soj ntsuam thiab kev pom zoo ua tsis tiav tsab ntawv ceeb toom ntawm kev tsis pom zoo hauv 20 hnub ua haujlwm txij hnub tau txais cov ntawv sau ceeb toom, kev hloov kho ntawm qhov kev qhia meej yuav siv.
Tshooj 17 rau cov cuab yeej siv kho mob uas tau ua, yog tias cov ntsiab lus tso rau hauv cov ntaub ntawv cov ntaub ntawv, cov kev xav tau ntawm cov khoom lag luam, thiab lwm cov ntsiab lus ntawm phau ntawv hloov, phau ntawv yuav hloov kho cov ntsiab lus muaj feem ntawm phau ntawv thiab daim ntawv lo ntawm nws tus kheej Cov.
Tshooj 18 Yog tias cov lus qhia thiab cov ntawv sau tsis tau raws li cov cai ntawm cov kev tswjfwm no, cov zaubmov noj zaubmov thiab yeeb tshuaj hauv lub nroog lossis siab dua lub nroog yuav raug rau txim raws li Txoj Cai 67 ntawm Txoj Cai Tswj Xyuas thiab Tswj Xyuas Kev Kho Mob.
Tshooj 19 Cov kev cai no yuav pib ua haujlwm txij lub Kaum Hlis 1, 2014. Cov kev cai ntawm Kev Tswj Xyuas Khoom Siv Khoom Kho Mob, Cov Ntawv Cim thiab Ntim Cim (yav tas los txiav txim No. 10 ntawm Lub Xeev Khoom Noj thiab Tshuaj Siv) tau tshaj tawm thaum Lub Xya Hli 8, 2004 yuav tsum yog tshem ib txhij.
