Txij Lub Ib Hlis 1, 2022, txhua yam khoom siv kho mob tshiab nkag mus rau Eurasian Economic Union lub teb chaws xws li Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, thiab lwm yam yuav tsum tau sau npe raws li Union EAC MDR cov cai. Tom qab ntawd lees txais daim ntawv thov rau daim ntawv pov thawj kev kho mob rau ib lub tebchaws. Cov cuab yeej kho mob uas tau sau npe hauv Lavxias Federation tuaj yeem siv txuas ntxiv, lossis daim ntawv pov thawj sau npe tuaj yeem hloov kho kom txog thaum 2027.
EAC MDR Product Classification
Raws li cov qib kev pheej hmoo sib txawv, EAC MDR tuaj yeem muab faib ua Chav Kawm I, Chav Kawm IIa, Chav Kawm IIb, Chav Kawm III, ntawm chav kawm III muaj qhov pheej hmoo siab tshaj plaws, zoo ib yam li European Union. Qhov siab dua qhov kev pheej hmoo, qhov siab dua cov txheej txheem sau npe thiab cov cai.
EAC MDR Certification Process
1. Kev txiav txim siab txog qib kev pheej hmoo thiab hom npe siv 2. Kev txiav txim siab ntawm cov ntaub ntawv txheeb xyuas 3. Kev sau cov pov thawj ntawm kev nyab xeeb thiab kev ua tau zoo 4. Kev xaiv cov xwm txheej siv thiab kev txheeb xyuas
5. Them kev lis kev cai
6. Xa cov ntaub ntawv
7. Kev tshuaj xyuas ntau lawm ntawm cov khoom siv kho mob, thiab lwm yam.
8. Cov txheej txheem pom zoo
9. Kev sau npe ntawm cov cuab yeej kho mob
Cov ntaub ntawv pov thawj EAC MDR
Daim ntawv teev cov ntaub ntawv hauv qab no yog xaiv tau, nyob ntawm qhov kev pheej hmoo ntawm cov khoom kom paub meej tias nws yuav tsum tau muab.
1. Thov nyob rau hauv daim ntawv teev npe nyob rau hauv daim ntawv ntxiv
2 thiab 3 ntawm "Kev Sau Npe thiab Cov Cai Ua Haujlwm rau Kev Nyab Xeeb, Zoo thiab Ua Haujlwm ntawm Cov Khoom Siv Kho Mob"
3. Daim ntawv tso cai sawv cev rau kev txaus siab ntawm cov chaw tsim khoom thaum tso npe
4. Ib daim ntawv theej ntawm cov chaw tsim khoom siv kho mob daim ntawv pov thawj kev tswj hwm kev ua tau zoo (ISO 13485 lossis cov qauv hauv cheeb tsam lossis lub teb chaws cov qauv ntawm cov tswv cuab hauv lub xeev)
5. Cov cuab yeej kho mob kev nyab xeeb thiab kev ua tau zoo raws li kev tshaj tawm lossis cov ntaub ntawv sib npaug
6. Daim ntawv pov thawj sau npe tau muab los ntawm lub teb chaws tsim khoom (Daim ntawv pov thawj ntawm kev muag khoom dawb, daim ntawv pov thawj xa tawm (tshwj tsis yog cov khoom siv kho mob ua ntej tsim nyob rau hauv thaj chaw ntawm Lub Xeev Cov Tswv Cuab)) thiab txhais ua lus Lavxias
7. Daim ntawv luam ntawm cov ntaub ntawv pov thawj kev tso npe hauv lwm lub tebchaws
8. Daim ntawv pov thawj kho mob hais txog cov cuab yeej kho mob Scope, siv, cov yam ntxwv luv luv, versions thiab accessories (cov ntaub ntawv)
9. Kev kos npe thiab ntim cov ntaub ntawv (cov xim tag nrho ntawm cov ntim thiab cov ntawv cim, cim cov ntawv hauv Lavxias thiab cov lus tseem ceeb ntawm cov tswv cuab hauv lub xeev)
10. Kev tsim kho thiab kev tsim cov ntaub ntawv: kev tsim cov txheej txheem kos duab, Cov kauj ruam tseem ceeb ntawm kev tsim khoom, ntim, kev sim thiab cov txheej txheem tso tawm cov khoom kawg
11. Cov ntaub ntawv hais txog cov chaw tsim khoom: lub npe, hom kev ua haujlwm, chaw nyob raws cai, daim ntawv ntawm kev ua tswv cuab, kev tswj hwm, cov npe ntawm cov tuam haujlwm thiab cov koom haum, thiab cov lus piav qhia ntawm lawv cov xwm txheej thiab lub zog
12. Incidents and Recall report (tsis muab cov ntaub ntawv qhia txog cov khoom siv kho mob uas tau tsim thiab tsim tshiab): cov npe ntawm cov xwm txheej tsis zoo lossis xwm txheej cuam tshuam nrog kev siv cov cuab yeej, thiab qhia txog lub sijhawm uas cov xwm txheej no tshwm sim, yog tias muaj Muaj ntau qhov xwm txheej tsis zoo, tej zaum yuav tsim nyog rau Hom Teeb Meem Muab cov ntsiab lus luv luv thiab qhia tag nrho cov xwm txheej qhia rau txhua hom A daim ntawv teev cov lus pom thiab / lossis cov lus piav qhia rau kev lag luam khoom siv kho mob thiab piav qhia txog qhov xwm txheej, cov txheej txheem los daws lawv thiab cov chaw tsim khoom hauv txhua rooj plaub Qhov kev daws teeb meem piav qhia txog kev tshuaj xyuas thiab / lossis kev kho kom raug coj los teb rau cov xwm txheej no 13. Daim ntawv teev cov qauv uas cov cuab yeej kho mob ua raws (nrog cov ntaub ntawv cuam tshuam)
14. Cov kev cai dav dav, cov ntawv sau npe thiab cov ntaub ntawv xav tau los ntawm cov ntaub ntawv ua haujlwm (tom qab no hu ua - cov kev cai dav dav)
15. Cov ntaub ntawv tsim kom muaj cov yam ntxwv ntawm cov cuab yeej siv kho mob 16. Cov ntawv ceeb toom ntawm cov kev sim ntsuas tau ua los ua kom pom kev ua raws li cov kev cai dav dav
17. Cov txheej txheem rau kev tshawb fawb (kev ntsuam xyuas) los ntsuam xyuas cov teebmeem lom ntawm cov khoom siv kho mob, Lub hom phiaj ua kom pom kev ua raws li cov kev cai dav dav
18. Cov ntaub ntawv pov thawj kho mob qhia txog kev ua tau zoo thiab kev nyab xeeb ntawm cov cuab yeej kho mob
19. Daim ntawv qhia txog kev pheej hmoo
20. Cov ntaub ntawv tshuaj nyob rau hauv cov khoom siv kho mob (tshuaj muaj pes tsawg leeg, kom muaj nuj nqis, cov ntaub ntawv siv tshuaj thiab cov khoom siv kho mob, kev sau npe ntawm cov khoom siv tshuaj hauv lub tebchaws)
21. Biosafety cov ntaub ntawv
22. Sterilization txheej txheem cov ntaub ntawv, suav nrog cov txheej txheem validation, microbiological xeem tau (theem ntawm bioburden), pyrogenicity, sterility (yog tias tsim nyog), thiab xeem cov lus qhia thiab ntim cov ntaub ntawv ntawm validation cov ntaub ntawv (sterile khoom)
23. Cov ntaub ntawv software tshwj xeeb (yog tias muaj): Chaw tsim khoom cov ntaub ntawv ntawm software validation
24. Daim ntawv qhia txog kev ruaj ntseg - nrog cov lus txhais lus Lavxias ntawm cov txiaj ntsig kev xeem thiab cov lus xaus rau cov khoom nrog lub txee lub neej
25. Siv nyob rau hauv lub teb chaws lees paub Kev khiav hauj lwm cov ntaub ntawv los yog cov lus qhia rau kev siv cov cuab yeej kho mob nyob rau hauv lub teb chaws hom lus (yog tias tsim nyog) thiab nyob rau hauv Lavxias teb sab
26. Cov ntawv qhia kev pabcuam (nyob rau hauv cov ntaub ntawv ntawm cov khoom siv kho mob) - thaum tsis muaj cov ntaub ntawv hauv cov ntaub ntawv ua haujlwm
27. Kev tshuaj xyuas ntau lawm 28. Kev npaj rau kev sau thiab tshuaj xyuas cov ntaub ntawv ntawm kev nyab xeeb thiab kev ua tau zoo ntawm cov cuab yeej siv kho mob nyob rau theem tom qab kev lag luam