Txhawm rau txhawm rau txhawm rau txhim kho kev hloov kho ntawm cov cuab yeej kho mob tshuaj xyuas thiab kev pom zoo, raws li kev txhim kho ntawm kev lag luam khoom siv kho mob thiab kev saib xyuas thiab kev tswj xyuas cov cuab yeej kho mob, raws li "Cov Cai Tswj Xyuas Kev Tswj Xyuas thiab Kev Tswj Xyuas Cov Khoom Siv Kho Mob" , "Kev faib cov cuab yeej kho mob Catalog Dynamic Adjustment Work Procedures", Lub Xeev Lub Tuam Txhab Tshuaj tau txiav txim siab los kho qee cov ntsiab lus ntawm "Kev faib Catalog ntawm Cov Khoom Siv Kho Mob".Cov teeb meem cuam tshuam tau tshaj tawm raws li hauv qab no:
Kev hloov kho ntawm 58 chav kawm ntawm cov cuab yeej kho mob ntsig txog cov ntsiab lus ntawm "Kev Kho Mob Cov Khoom Siv Kho Mob Catalog", cov kev hloov kho tshwj xeeb tau qhia hauv daim ntawv txuas ntxiv.
Kev yuav tsum tau ua
(I) Rau cov kev hloov kho nyob rau hauv Annex hais txog 01-01-03 "ultrasonic surgical khoom accessories" nyob rau hauv lub "ultrasonic txiav thiab hemostasis lub taub hau, ultrasonic mos ntaub so ntswg phais taub hau, ultrasonic suction phais taub hau" thiab 01-01-06 "lub mis rotary excision biopsy system thiab khoom siv" uas tau tswj hwm raws li Chav Kawm III cov cuab yeej kho mob, txij li hnub tshaj tawm cov lus tshaj tawm no, lub chaw tswj hwm tshuaj yuav tsum, raws li "Kev Sau Npe Kho Mob thiab Cov Khoom Siv", "cov koob tshuaj tiv thaiv lub mis rotary excision puncture koob thiab accessories ".Lub mis rotary excision biopsy system thiab cov khoom siv" hauv "Lub mis rotary excision puncture koob thiab cov khoom siv", txij li hnub tshaj tawm no, lub chaw saib xyuas tshuaj thiab kev tswj xyuas raws li "Kev Sau Npe Tshuaj Kho Mob thiab Kev Tswj Xyuas Kev Ntsuas" "Ntawm Tshaj Tawm ntawm Cov Kev Xav Tau rau Kev Sau Npe Cov Khoom Siv Kho Mob thiab Hom Ntawv Pom Zoo" thiab lwm yam.Kev Tshaj Tawm Txog Kev Tshaj Tawm Txog Kev Tshaj Tawm Txog Kev Sau Npe Kho Mob thiab Hom Ntawv Tso Cai ", thiab lwm yam, lub tuam tsev tswj hwm tshuaj yuav lees txais daim ntawv thov rau npe ntawm cov cuab yeej kho mob raws li qib kho.
Rau qhov kev tshaj tawm tau txais kev pom zoo ua ntej ua tiav kev tso npe tso npe pom zoo (nrog rau thawj qhov kev tso npe thiab kev sau npe txuas ntxiv) ntawm cov cuab yeej siv kho mob, cov chaw saib xyuas tshuaj thiab kev tswj xyuas txuas ntxiv mus saib xyuas thiab pom zoo raws li thawj qhov kev lees paub ntawm qeb, kev tso npe tso cai, kev tshaj tawm daim ntawv pov thawj ntawm cov cuab yeej siv kho mob, txwv rau kev siv tau ntawm daim ntawv pov thawj ntawm kev sau npe ntawm cov cuab yeej kho mob rau lub sijhawm kawg ntawm lub Kaum Ob Hlis 31, 2025, thiab hauv kab ntawv sau npe cov lus hais tom qab kev hloov kho ntawm qeb ntawm kev tswj cov khoom.Rau tau txais daim ntawv pov thawj ntawm cov khoom siv kho mob Class II, ua ntej Lub Kaum Ob Hlis 31, 2025 cov khoom lag luam daim ntawv pov thawj kev sau npe tseem siv tau, tus neeg sau npe yuav tsum tau koom nrog raws li cov kev cai ntawm pawg tswj hwm coj los ua kom muaj kev hloov pauv ntawm kev sau npe. daim ntawv pov thawj, ua ntej lub Kaum Ob Hlis 31, 2025 kom ua tiav qhov hloov dua siab tshiab.Ua haujlwm hloov dua siab tshiab thaum lub sij hawm daim ntawv pov thawj kev kho mob thawj zaug tas sij hawm, nyob rau hauv cov khoom muaj kev ruaj ntseg thiab ua tau zoo thiab teev nyob rau hauv lub chaw ua hauj lwm ntawm tsis muaj teeb meem loj tshwm sim los yog tsis zoo xwm txheej, tus sau npe yuav ua tau raws li cov thawj tswj cov yam ntxwv thiab pawg rau tus thawj. Lub tuam tsev pom zoo los thov kev ncua ntxiv, txuas ntxiv, qhov siv tau ntawm daim ntawv pov thawj kev kho mob thawj zaug yuav tsum tsis pub tshaj lub Kaum Ob Hlis 31, 2025.
Txij li thaum Lub Ib Hlis Ntuj Tim 1, 2026, cov khoom no yuav tsum tsis txhob raug tsim, xa tawm thiab muag yam tsis tau txais daim ntawv pov thawj rau npe rau Class III cov cuab yeej kho mob raws li txoj cai.Cov tuam txhab tsim khoom lag luam yuav tsum ua kom zoo siv lub luag haujlwm tseem ceeb rau cov khoom lag luam zoo thiab kev nyab xeeb kom ntseeg tau tias muaj kev nyab xeeb thiab ua tau zoo ntawm cov khoom teev tseg.
(B) rau kev hloov kho cov ntsiab lus ntawm lwm yam khoom, txij li hnub tshaj tawm tsab ntawv tshaj tawm no, kev saib xyuas tshuaj thiab kev tswj xyuas raws li "Sau npe thiab xa cov khoom siv kho mob" "ntawm cov lus tshaj tawm ntawm cov cai rau kev sau npe ntawm cov cuab yeej kho mob tshaj tawm cov ntaub ntawv thiab kev pom zoo ntawm hom ntawv ntawm cov ntaub ntawv" "ntawm kev ua ntaub ntawv ntawm Class I cov cuab yeej kho mob ntawm kev tshaj tawm txog cov teeb meem cuam tshuam" thiab lwm yam, raws li qeb kho kom lees txais daim ntawv thov rau npe ntawm cov cuab yeej kho mob lossis rau daim ntawv.
Rau qhov lees paub tseem tsis tau ua tiav daim ntawv tso cai rau kev tso npe (nrog rau thawj daim ntawv sau npe thiab rov ua dua tshiab) ntawm cov cuab yeej kho mob, kev saib xyuas tshuaj thiab kev tswj xyuas txuas ntxiv mus xyuas thiab pom zoo raws li cov thawj qeb ntawm kev lees txais, kev tso npe tso npe, tso tawm ntawm daim ntawv pov thawj ntawm cov cuab yeej kho mob, thiab nyob rau hauv daim ntawv pov thawj daim ntawv pov thawj cov lus hais tom qab kev hloov kho ntawm pawg tswj cov khoom.
Rau cov khoom siv kho mob tau sau npe, nws pawg tswj hwm los ntawm chav kawm thib peb tau hloov kho mus rau chav kawm thib ob, daim ntawv pov thawj kho mob sau npe hauv lub sijhawm siv tau tseem siv tau.Yog tias koj xav tau txuas ntxiv, tus neeg sau npe yuav tsum nyob rau hauv daim ntawv pov thawj kev kho mob daim ntawv pov thawj yuav tas sij hawm 6 lub hlis ua ntej hnub tas sij hawm, raws li qeb tom qab kev hloov pauv mus rau lub chaw saib xyuas tshuaj thiab kev tswj xyuas kom tsim nyog rau kev thov rov ua dua kev sau npe, tso cai rau kev rov ua dua tshiab. ntawm kev sau npe, raws li kev hloov kho qeb ntawm kev tswj xyuas cov khoom lag luam tawm los ntawm daim ntawv pov thawj ntawm cov cuab yeej siv kho mob.
Rau cov khoom siv kho mob tau sau npe, nws pawg tswj hwm los ntawm chav kawm thib ob tau hloov kho rau thawj chav kawm, daim ntawv pov thawj kev kho mob rau lub sijhawm siv tau txuas ntxiv mus.Ua ntej hnub tas sij hawm ntawm daim ntawv pov thawj sau npe, tus neeg sau npe tuaj yeem thov rau cov ntaub ntawv cov khoom mus rau lub tuam tsev sib raug.
Daim ntawv pov thawj ntawm cov cuab yeej siv kho mob hauv qhov kev siv tau ntawm kev hloov pauv kev sau npe, tus neeg sau npe yuav tsum tau thov rau thawj qhov chaw sau npe los hloov daim ntawv sau npe.Yog tias daim ntawv pov thawj kev tso npe thawj zaug raug muab tso rau raws li tus thawj "Cov Khoom Siv Kho Mob Classification Catalog", cov lus tshaj tawm no cuam tshuam txog kev hloov pauv ntawm cov ntaub ntawv sau npe cov khoom yuav tsum tau qhia hauv kab lus tom qab ua raws li cov lus tshaj tawm ntawm pawg tswj hwm cov khoom.
(C) Lub chaw saib xyuas tshuaj thiab kev tswj hwm ntawm txhua qib kom ntxiv dag zog rau "Medical Device Classification Catalog" kev hloov kho cov ntsiab lus ntawm kev tshaj tawm thiab kev cob qhia, thiab ua haujlwm zoo txog kev tshuaj xyuas cov khoom thiab kev pom zoo, ua ntaub ntawv thiab kev saib xyuas tom qab kev lag luam.
Post lub sij hawm: Aug-24-2023