Ntiaj teb no-Wide Certification Update: Intra-Oral Scanners raug them raws li Nyiv lub National Health-insurance Policy, accounting tshiab lag luam prospects
Nyiv tau tso cai ntxiv cov tshuab ntsuas hauv qhov ncauj rau nws cov ntawv pov hwm kev noj qab haus huv rov qab. Kev ua lag luam xav tau rau cov khoom siv kho hniav digital no tau kwv yees kom nce siab, ua rau muaj kev xa tawm ntau thiab kev lag luam dav dav rau cov tuam txhab suav tshuaj kho mob hauv Suav teb.
Txoj Cai Keeb Kwm Keeb Kwm
Xyoo 2024, Central Social Insurance Medical Council ntawm Nyij Pooj tau tshaj tawm tsab ntawv ceeb toom zaum kawg ntawm kev hloov kho tus nqi kho mob rau tus kheej cov khoom kho mob thaum lub rooj sib tham dav dav. Optical-impression intra-oral scanners tau txais kev tsim nyog tau txais kev pov hwm kev noj qab haus huv. Txoj cai cia siab tias yuav ua rau muaj kev loj hlob sai hauv kev lag luam hauv tebchaws thiab tsim kom muaj txiaj ntsig zoo rau kev xa tawm txawv teb chaws rau cov neeg tsim khoom hauv Suav teb.
Basic Introduction to Intra-Oral Scanners
Txhais thiab Core Functions
Raws li high-precision digital kho hniav cov cuab yeej, intra-oral scanners txais laser-based lossis optical imaging thev naus laus zis los ntes cov ntaub ntawv ntawm qhov ncauj ua tiav hauv lub sijhawm luv. Cov ntaub ntawv scanned muaj cov ntaub ntawv morphological thiab xim ntawm cov tawv nqaij ntawm qhov ncauj thiab cov nqaij mos nrog rau cov hniav thiab cov gingiva, ua ib qho kev hloov pauv digital rau cov qauv siv silicone-raws li lub cev kev xav.
Lub zog sib tw tseem ceeb
Intra-oral scanners zoo heev txhim kho cov kev kho hniav ib txwm ua haujlwm, nqa kev kho mob kom zoo thiab scanning precision raws li cov khoom siv tseem ceeb rau digitized stomatology. Nrog rau qhov pom 3-D cov ntaub ntawv qhov ncauj, cov kws kho hniav tuaj yeem txheeb xyuas qhov mob ntawm qhov ncauj intuitively thiab tsim cov phiaj xwm kho tau zoo.
Tag Nrho Cov Ntawv Sau Npe Ua Haujlwm rau Intra-Oral Scanners hauv Nyij Pooj
Kauj ruam-by-step Market-access Procedures
Txheeb xyuas qhov kev faib khoom siv kho mobTxiav txim siab qib kev pheej hmoo ntawm lub tshuab nqus tsev hauv qhov ncauj raws li Nyiv PMD-Act thiab cov ntaub ntawv kho mob-cov cuab yeej coding glossary, cov kauj ruam hauv paus rau kev sau npe tom ntej.
Teem ib tus neeg sawv cev hauv zos uas tau tso caiTsim ib tus tsim nyog Kev Tso Cai Ua Lag Luam (MAH) lossis Tsim-MAH los saib xyuas kev sau npe hauv zos thiab tswj kev sib txuas lus ntawm cov tuam txhab txawv teb chaws thiab cov cai tswj hwm Nyij Pooj.
Ua kom tiav kev tso npe rau cov neeg tsim khoom txawv teb chawsCov neeg tsim khoom txawv teb chaws yuav tsum xa daim ntawv thov Kev Sau Npe Txawv Teb Chaws Chaw Tsim Khoom (FMR) mus rau Lub Chaw Haujlwm Saib Xyuas Tshuaj thiab Kho Mob (PMDA), qhov yuav tsum tau ua rau nkag mus rau hauv Nyij Pooj.
Tsim kom muaj raws li Kev Tswj Xyuas-System (QMS)Cov lag luam xav tau kev ua raws li PMD-Act thiab MHLW (Ministry of Health, Labor thiab Welfare) Ministerial Ordinance No.169, ua kom cov khoom ruaj ntseg ruaj ntseg thiab zoo ib yam.
Xa cov ntaub ntawv pov thawj ua ntej ua lag luamTua tawm daim ntawv thov kev lag luam nkag los ntawm Registered-Certification-Body (RCB) lossis xa ncaj qha PMDA.
Tau txais daim ntawv pov thawj kev lag luamTom qab kev tshuaj xyuas thiab kev tshuaj xyuas cov ntaub ntawv, cov cuab yeej tsim nyog yuav tau txais kev tso cai ua lag luam rau kev muag khoom raug cai thoob plaws Nyiv.
Yuav tsum muaj ntaub ntawv sau npe
Cov lus piav qhia ntxaws npog cov ntawv thov kev kho mob npaj
Lub npe ntawm cov khoom lag luam
Khoom qauv, tsos thiab specifications
Cov txheej txheem ua haujlwm thiab ua tiav cov txheej txheem tsim khoom
Cov ntaub ntawv khaws cia ib puag ncig thiab cov ntaub ntawv khaws cia
Yuav tsum tau Labeling Specifications
Tshooj 63 ntawm PMD-Act qhia txog cov ntaub ntawv sau npe sau rau ntawm cov thawv ntim khoom thiab cov pob khoom sab nraud:
Lub npe thiab qhov chaw nyob ntawm Tus Neeg Tso Cai Ua Lag Luam
Cov khoom siv npe
Ntau lawm batch tooj los yog manufacturing code
Nyhav, ntim los yog kom muaj nuj nqis specifications
Hnub tim kos npe
Ntxiv cov ntawv sau npe yog raug siv raws li Tshooj 41 (3) thiab Tshooj 42 (2), ua raws li cov qauv kev nyab xeeb hauv lub tebchaws.
Profile ntawm Wiselink Nyiv ceg
Wiselink JP, lub tuam txhab Nyij Pooj ntawm Wiselink, khav theeb cov kws tshaj lij hauv Nyij Pooj kev kho mob-cov cuab yeej ua raws cai thiab cov ntawv pov thawj. Nws xa cov ntawv sau npe hauv zos rau cov neeg xa khoom tawm txawv teb chaws, suav nrog cov khoom siv kho hniav, tshuaj pleev ib ce, khoom noj khoom haus qib thiab cov tshuaj kho mob.
Wiselink CN sib sau ua ke pab pawg neeg sab laj thoob ntiaj teb, nrog Dr. Derrick Beech, tus thawj coj ntawm Australia lub TGA, ua tus kws pab tswv yim. Rooted nyob rau hauv Australia-keeb kwm kev txawj ntse thiab raws li nyob rau hauv Suav teb, pab neeg ua hauj lwm thoob ntiaj teb manufacturers nrog raws li daim ntawv pov thawj thiab soj ntsuam-sim kev pab cuam rau kev kho mob cov cuab yeej, tshuaj pleev ib ce, zaub mov, khoom siv kho mob thiab cov khoom siv tshuaj suav tshuaj.
