Medical Device Operation Permit Application nyob rau hauv Suav teb
Yuav tsum tau thov rau Class II Medical Device Operation Permit
Muaj peb chav kawm ntawm cov khoom siv kho mob. Rau Chav Kawm I, lub tuam txhab yuav tsum muaj feem cuam tshuam txog kev lag luam; Raws li rau Chav Kawm II, lub tuam txhab yuav tsum tau thov rau cov ntaub ntawv ua haujlwm; thiab rau Chav Kawm III, lub tuam txhab yuav tsum thov rau daim ntawv tso cai ua haujlwm.
1. Tau txais lub tuam txhab sau npe nrog kev lag luam ntawm "muag khoom siv kho mob Class II".
2. Tsawg kawg yog ib tus neeg ua haujlwm uas muaj daim ntawv kho mob lossis kws kho mob lossis siab dua (cov ntawv sau rov qab, daim ntawv tso cai, thiab pov thawj ntawm kev kawm).
3. Lub tsev khaws khoom tsis tu ncua nrog thaj tsam ntawm 45㎡ thiab tag nrho thaj tsam ntawm ntau tshaj 100㎡.
4. Ib daim ntawv pov thawj ntawm cov khoom vaj khoom tsev thiab daim ntawv cog lus xauj tsev (nqi xauj hauv lub tuam txhab npe).
5. Tus neeg yuav khoom yuav tsum muab: ib daim qauv ntawm daim ntawv tso cai ua lag luam, daim ntawv pov thawj ntawm cov khoom lag luam, daim ntawv pov thawj zoo, daim ntawv tso cai (stamped nrog cov ntaub ntawv pov thawj).
6. Daim ntawv tso cai ua lag luam nrog kev foob, thiab lwm yam.
Enterprise Service Case
Yuav tsum tau thov rau Class III Medical Device Operation Permit
Peb yuav tsum tau kuaj xyuas daim ntawv pov thawj ntawm cov khoom siv kho mob Class III ua ntej, muab cov ncauj lus kom ntxaws ntxiv rau koj siv.
1. Tau txais lub tuam txhab sau npe nrog kev lag luam ntawm "muag khoom siv kho mob Class III".
2. Cov neeg ua haujlwm: Tag nrho ntawm 9 txoj haujlwm tau teeb tsa hauv Chav Kawm III cov cuab yeej kho mob uas ua haujlwm zoo ib yam, suav nrog cov neeg sawv cev raug cai, tus thawj coj ua lag luam, tus thawj coj zoo, tus thawj coj zoo ntawm lub koom haum kev tswj hwm, tus neeg soj ntsuam, kev muag khoom, kev muag khoom tom qab, kev tswj cov khoom lag luam, thiab lub computer. kev tswj hwm. Cov haujlwm no tuaj yeem tuav tau ib txhij, tab sis tsawg kawg yog 3 tus neeg ua haujlwm, nrog rau cov ntaub ntawv xws li tus thawj thiab daim ntawv pov thawj thiab daim ntawv pov thawj kev kawm. Lub caij no, tus thawj tswj hwm zoo yuav tsum muaj 3 xyoos ntawm kev tswj hwm thiab kev kho mob ntsig txog kev kawm.
Yog tias lub tuam txhab yuav ua haujlwm hauv vitro diagnostic reagent, implants thiab interventional cov cuab yeej kho mob, hu rau lub lens lossis lwm yam khoom siv kho mob tshwj xeeb, yuav tsum muaj ntau dua rau cov neeg ua haujlwm. Thov hu rau peb cov kws pab tswv yim kom paub ntau ntxiv.
2. Kev tswj cov cuab yeej kho mob software (yuav tsum tau yuav daim ntawv them nqi).
3. Ib daim ntawv pov thawj ntawm cov khoom vaj khoom tsev thiab daim ntawv cog lus xauj tsev (nqi xauj hauv lub tuam txhab npe).
4. Tus neeg yuav khoom yuav tsum muab: thawj thiab luam theej daim ntawv pov thawj ntawm kev sau npe thiab cov khoom lag luam ntsig txog kev tsim nyog (daim ntawv tso cai ua lag luam, daim ntawv pov thawj kev kho mob daim ntawv pov thawj), stamped nrog official foob (muab cov chaw tsim khoom lossis daim ntawv pov thawj ntawm tus neeg sawv cev sau npe).
5. Kev tswj hwm kev lag luam, kev pab cuam tom qab muag, kev cob qhia cov neeg ua haujlwm.
6. Daim ntawv tso cai ua lag luam nrog kev foob, thiab lwm yam.
Peb muaj peev xwm muab qhov chaw sau npe rau peb cov neeg siv khoom uas xav koom nrog kev lag luam kho mob tab sis tseem tsis tau xauj chaw ua haujlwm. Nrog peb yuav luag 20 xyoo kev lag luam kev lag luam thiab cov peev txheej ntau, peb yuav pab koj mus dhau txoj kev ua haujlwm zoo.